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He got his cheek swabbed at 24. Nothing happened for 14 years. – Las Vegas Review-Journal

By daniellenierenberg

Cade Cridland thought a lot about fate as he sat tethered to a machine that drained blood from one arm and pumped it back into his body through the other arm.

After four hours, blood stem cells processed by the machine would be flown thousands of miles to a young child he has never met. A child whose name he does not know.

A child battling blood cancer.

This story unfolded in a Denver hospital in September. But it began 14 years earlier with a split-second decision in Las Vegas when Cridland was 24.

Before the child was born.

Im not a religious person by any means, Cridland, now 38, said. But I do believe that theres a lot of fate that takes place in our actions on a day-to-day basis.

The year is 2006. George W. Bush is president.

And Cridland, a recent UNLV graduate with a bachelors degree in journalism and media studies, had just left his part-time job with Vegas PBS for a full-time job with the local chapter of the Leukemia and Lymphoma Society.

Through his new job, Cridland soon found himself at a donation drive, hosted by a charity called Be the Match, for a family desperately searching for a bone marrow donor.

For patients diagnosed with leukemia or lymphoma, a bone marrow or cord blood transplant may be their only hope for a cure.

Cridland was there to work the event, but he drew inspiration from those around him getting swabbed. Whats the harm, he thought.

That day, his DNA was packaged and shipped off to be entered in the National Bone Marrow Registry.

He wasnt a match. Life went on, and eventually Cridland forgot about the swab.

In the meantime, he moved on to a job with the Clark County School District, got married, adopted a dog, had two children, bought a house, got another dog.

Fourteen years came and went, and now it was 2020.

The phone call

The call came at the best time, during arguably one of the worst years in modern history. The 2020 pandemic was in full swing. Protests over racism and police brutality had taken hold of a divided nation.

Cridland, a spokesman for the school district, needed something good to focus on.

But when that something good came calling earlier this year, he almost didnt answer. A toll-free number lit up the screen. A telemarketer maybe, or a scam?

Cridland surprised himself and took the call.

I dont know if you remember this, Cridland recalled a woman on the other end explaining. But you gave a cheek swab at one of our events, and theres a possibility that this cheek swab is a match for a child in need of stem cells or marrow to help them fight blood cancer.

The woman, an employee of Be the Match, ended the call with a question: Would you be willing to donate?

She gave Cridland the weekend to think it over. But for Cridland and his wife, who have two young children, it was a no-brainer.

Not long after, a second cheek swab confirmed what the woman had told Cridland during their phone call.

He was a match for the patient. In this case, that meant at least eight specific genetic markers in Cridlands DNA, called human leukocyte antigens, matched the patients DNA.

Every one individual has their own unique genetic DNA code, said Erica Sevilla, a spokeswoman for Be the Match. What were looking to attach to that code is protein markers that tell your body what cells belong in the body and what cells do not. Essentially, youre looking to match immune systems between the donor and the patient.

From there, the patients doctor will decide the best course for treatment.

According to Be the Match, many believe that the only way to donate blood stem cells is through a surgical procedure, during which the donor receives anesthesia and a needle is used to extract liquid marrow from the pelvic bone. But 79 percent of donations are done through a nonsurgical procedure known as a peripheral blood stem cell donation.

The doctor in Cridlands donation case chose the nonsurgical route.

During the week leading up to the donation, Be the Match sent a nurse to Cridlands home in Henderson once a day for five consecutive days to administer injections of a medication that increased the number of blood-forming cells in Cridlands bloodstream.

Cridland and his wife were flown to Denver for the procedure.

At times throughout the donation process, which spanned about five months from the first phone call to the day of the procedure, Cridland would find himself moved to tears, overcome by his gratitude for the chance to help save a young child.

To me, the crazy thing about all this is that my actions from 14 years ago have had a dramatic effect on how somebody else is living in 2020, he said in an interview this month at his home. With all the negativity weve seen this year, this one family may look at 2020 as the best year of their lives because of this one specific moment in my life that took place 14 years ago.

Even now, three months removed from donation day, Cridland at random will break down in tears.

Sometimes he thinks about his blood pumping through the childs body. How a piece of him will always be with that child. How someone he has never met, and may never meet, could be such a close genetic match to him.

How were all more alike than we think.

Epilogue

I wish I could take this feeling, put it in a can and throw a lid on top, Cridland said of his experience donating stem cells.

If that were possible, Cridland said, he would pass it around like a party favor but he cant.

So instead, hes hoping his story will inspire others, especially people of color, to join the registry and give the gift of a cure to another patient in need.

Currently, there is a severe shortage of diverse donors in the national registry, which consists of 22 million donors. More than 13 percent of the American population is Black, for example, yet only about 4 percent of registered donors are Black.

And the disparity is costing lives.

Matching is based on genetic markers that can be traced back to your grandparents and your great-grandparents, said Sevilla, the spokeswoman for Be the Match. Theyre traced back to the very origins of your family, so thats why people who are of European descent have an easier time finding a match, whereas people who descended from slavery, for example, have a harder time.

To join the National Bone Marrow Registry and request a cheek swab kit, visit http://www.join.bethematch.org.

Meanwhile, as of mid-December, Cridland knew only that the patient had received his stem cells. He wasnt sure, even, if hed ever meet the child.

Both parties must consent to meeting, and different countries operate under varied cooling-off periods. For some countries, a patient and a donor must wait two years before they can meet or even speak.

As a donor, Cridland was told the patients age, specific diagnosis and city and country of residence. But he is not allowed to disclose that information to protect the patients privacy.

According to Be The Match, 50 percent of all marrow or stem cell donations are international.

We are either exporting cells or importing cells, said Sevilla, the charity spokeswoman.

Cridland gave his consent for the patients family to reach out to him in the future. For now, its a waiting game.

If the moment comes that they try to connect, Ill be there, he said.

Contact Rio Lacanlale at rlacanlale@reviewjournal.com or 702-383-0381. Follow @riolacanlale on Twitter.

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Study clarifies the impact of getting old on hematopoietic stem cells – Microbioz India

By daniellenierenberg

By shifting mouse elderly hematopoietic stem cells (aged HSCs) to the environment of young mice (bone marrow niche), it was shown that the pattern of stem cell gene expression was rejuvenated to that of young hematopoietic stem cells. On the other hand, the function of elderly HSCs failed to recover in the young bone marrow niche. The epigenome (DNA methylation) of aged HSCs didnt change significantly even in the young bone marrow niche, and DNA methylation profiles were found to be a better index than the gene expression pattern of aged HSCs.

A research group headed by Professor Atsushi Iwama in the Division of Stem Cell and Molecular Medicine, The Institute of Medical Science, The University of Tokyo (IMSUT) declared these world-first Outcomes and was published in the Journal of Experimental Medicine (online) on November 24th.

The results will contribute to the development of treatments for age-related blood diseases.

Professor Atsushi Iwama, Lead Scientist, IMSUT

The research group investigated whether rejuvenating aged HSCs in a young bone marrow market environment would rejuvenate.

Tens of thousands of elderly hematopoietic stem/progenitor cells gathered from 20-month-old mice were transplanted into 8-week-old young mice without pretreatment like irradiation. After two months of follow-up, they collected bone marrow cells and performed flow cytometric analysis.

The research team also transplanted 10-week-old young mouse HSCs for comparison. In addition, engrafted aged HSCs were fractionated and RNA sequence analysis and DNA methylation analysis were conducted.

They discovered that engrafted elderly HSCs were less capable of producing hematopoietic cells compared to younger HSCs. They also showed that differentiation of aged HSCs into multipotent progenitor cells was persistently impaired even in the young bone marrow market, and that the direction of differentiation was biased. It was found that the transfer of aged HSCs into the young bone marrow market does not enhance their stem cell function.

A more detailed analysis may reveal mechanisms that irreversibly affect aged HSC functionAging studies focusing on HSCs have been chased in mice with a bone marrow transfer model. However, the effect of aging on HSCs remains to be clarified.

Professor Iwama says as follows. This analysis has a substantial impact because it clarified the effect of aging on HSCs. Our results are expected to contribute to further elucidation of the mechanism of aging in HSCs and comprehension of the pathogenic mechanism of age-related blood disorders.

Source:

Journal reference:

Kuribayashi, W.,et al.(2020) Limited rejuvenation of aged hematopoietic stem cells in young bone marrow niche.Journal of Experimental Medicine.doi.org/10.1084/jem.20192283.

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Scientists find new class of drugs that may treat blood, bone marrow cancer – Business Standard

By daniellenierenberg

A group of scientists in the US, including an Indian-American from the prestigious Cleveland Clinic, have identified a potential new class of drugs that may prove effective in treating certain common types of blood and bone marrow cancers.

First published in the latest edition of Blood Cancer Discovery, the decade long research which reports that a new pharmacological strategy to preferentially target and eliminate leukemia cells with TET2 mutations, was carried out by Jaroslaw Maciejewski and his collaborator Babal Kant Jha from the Cleveland Clinic Department of Translational Hematology & Oncology Research.

Myeloid leukemias are cancers derived from stem and progenitor cells in the bone marrow that give rise to all normal blood cells.

One of the most common mutations involved in driving myeloid leukemias are found in the TET2 gene, which has been investigated for the last decade by Maciejewski and Jha.

In preclinical models, we found that a synthetic molecule called TETi76 was able to target and kill the mutant cancer cells both in the early phases of disease--what we call clonal hematopoiesis of indeterminate potential, or CHIP--and in fully developed TET2 mutant myeloid leukemia," said Dr Maciejewski.

According to a media release, the research team designed TETi76 to replicate and amplify the effects of a natural molecule called 2HG (2-hydroxyglutarate), which inhibits the enzymatic activity of TET genes.

The TET DNA dioxygenase gene family codes for enzymes that remove chemical groups from DNA molecules, which ultimately changes what genes are expressed and can contribute to the development and spread of disease.

While all members of the TET family are dioxygenases, the most powerful enzymatic activity belongs to TET2, the press release said.

Even when TET2 is mutated, however, its related genes TET1 and TET3 provide residual enzymatic activity.

While significantly less, this activity is still enough to facilitate the spread of mutated cancer cells.

Maciejewski's and Jha's new pharmacologic strategy to selectively eliminate TET2 mutant leukemia cells centers on targeting their reliance on this residual DNA dioxygenase activity, it said.

We took lessons from the natural biological capabilities of 2HG, explained Jha, a principal investigator.

We studied the molecule and rationally designed a novel small molecule, synthesized by our chemistry group headed by James Phillips, PhD. Together, we generated TETi76a similar, but more potent version capable of inhibiting not just TET2, but also the remaining disease-driving enzymatic activity of TET1 and TET3, Jha said.

Cleveland Clinic said that the researchers studied TETi76's effects in both preclinical disease and xenograft models (where human cancer cells are implanted into preclinical models). Additional studies will be critical to investigate the small molecule's cancer-fighting capabilities in patients.

We are optimistic about our results, which show not just that TETi76 preferentially restricts the growth and spread of cells with TET2 mutations, but also gives survival advantage to normal stem and progenitor cells, Jha said.

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

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CAR T-Cell Therapies Are Set to Expand Into More Hematologic Malignancy Indications – Targeted Oncology

By daniellenierenberg

Multiple chimeric antigen receptor (CAR) T-cell therapies for the treatment of lymphomas and multiple myeloma have moved forward in the regulatory process, with 1 new FDA approval in 2020 and others anticipated in the near future.

In July, brexucabtagene autoleucel (Tecartus; KTEX19) received accelerated approval for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) based on the results of the phase 2 ZUMA-2 trial (NCT02601313), bringing the treatment landscape of this hematologic malignancy into a new era.1

This approval is only the very beginning, and we are walking into a sophisticated CAR T-cell therapy era with many constructs being designed with [different mechanisms of action], Michael Wang, MD, said in an interview with Targeted Therapies in Oncology (TTO).

Additional actions by the FDA this year included granting priority review designations to lisocabtagene maraleucel (liso-cel) for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma, after at least 2 prior therapies,2 as well as to idecabtagene vicleucel (ide-cel; bb2121)as treatment of adult patients with multiple myeloma who have received at least 3 prior therapies, including an immunomodulatory drug (IMiD), a proteasome inhibitor (PI), and an anti-CD38 antibody.3

The approval of brexucabtagene autoleucel, an antiCD19 CAR T-cell product, in MCL was based on objective response rate (ORR) data from patients treated on a single-arm trial who had previously received anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 antibody, and a Bruton tyrosine kinase inhibitor (n = 74).2,4 Eligible patients received leukapheresis and optional bridging therapy, followed by conditioning chemotherapy and a single infusion of brexucabtagene autoleucel 2 106CAR T cells/kg.

The results of ZUMA-2 were published in the New England Journal of Medicine in April and demonstrated a 93% (95% CI, 84%-98%) ORR in 60 response-evaluable patients, 67% (95% CI, 53%-78%) of whom had a complete response (CR). ORRs were consistent across key patient subgroups. Two patients (3%) each had stable and progressive disease.

Progression-free and overall survival (OS) rates at 12 months were 61% and 83%, respectively, and 57% of patients remained in remission at the 12.3-month median follow-up.4 Cytokine release syndrome (CRS) was the most concerning adverse event, occurring in 91% of patients; grade 3 or higher CRS occurred in 15%.

Notably, the patient cohort comprised patients with a median of 3 prior lines of therapy (range, 1-5) and more than half (56%) were considered to have intermediateor high-risk features by the simplified Mantle Cell Lymphoma International Prognostic Index at baseline.

Before CAR T-cell therapy, we did not have any effective means [of getting patients with high-risk MCL into remission]. We used allogeneic transplantation [and] were able to put some of the patients into a long-term remission, but at a heavy price of mortality, said Wang, a professor in the Department of Lymphoma & Myeloma, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center in Houston. Overall, this brings hope to the high-risk patient population. It looks as though fewer patients are relapsing.

Lisocabtagene Maraleucel In February, the FDA granted liso-cel a priority review designation, an action supported by the safety and efficacy findings of the phase 1 TRANSCEND-NHL-001 trial (NCT02631044).2

Histologic subtypes eligible for treatment included diffuse large B-cell lymphoma (DLBCL); high-grade double- or triple-hit B-cell lymphoma; transformed DLBCL from indolent lymphoma; primary mediastinal B-cell lymphoma; and grade 3B follicular lymphoma. Patients were administered 2 sequential infusions of CD8+ and CD4+ CAR T cells following optional bridging therapy and lymphodepleting chemotherapy and were assigned to 1 of 3 target dose levels: 50 106 (1 or 2 doses), 100 106 , or 150 106 CAR-positive T cells. Investigators determined that the recommended target dose was 100 106 CAR-positive T cells.

In the 256 patients who received at least 1 dose of liso-cel and were included in the efficacy-evaluable group, the ORR was 73% (95% CI, 67%-78%), with 53% (95% CI, 47%-59%) achieving a CR. Investigators observed all-grade CRS (42%) and neurological events (30%), but most cases were grade 1 or 2 in severity.

Due to relatively low rates of CRS and neurological events, the administration of liso-cel has been explored in both the inpatient and outpatient settings. One that included a cohort of patients treated in the outpatient setting with proper monitoring versus the traditional inpatient setting demonstrated consistent safety.6

Based on these results, the indication is that you can deliver [liso-cel] in the outpatient setting and the outcomes are good compared with those treated in the inpatient setting, explained study author Carlos R. Bachier, MD, the director of cellular research at Sarah Cannon in Nashville, Tennessee, in an interview with TTO. Aside from that, they also showed that liso-cel could be safely administered outside of university programs and in more community-based programs, most of them being aligned [with] or part of stem cell and bone marrow transplant programs.

The target action date for a decision on the biologics license application (BLA) for liso-cel was extended twice in 2020 and remains under review. In May, the FDA moved the Prescription Drug User Fee Act (PDUFA) goal date out 3 months from its original August deadline.2,7 Bristol Myers Squibb, the company responsible for developing the product, submitted additional information to the agency following the initial BLA submission, which resulted in more review time. Once again, the target action date was pushed in November, this time due to incomplete manufacturing facility inspections resulting from ongoing travel restrictions due to COVID-19. The FDA provided no new action date.8

For patients with multiple myeloma, the B-cell maturation antigen (BCMA)-targeting CAR T-cell therapy idecel is currently under review for approval in patients who have received at least 3 prior therapiesincluding an immunomodulatory drug (IMiD), a proteasome inhibitor (PI), and an anti-CD38 antibodybased on results of the phase 2 KarMMa trial (NCT03361748).9

Updated trial results were presented at the American Society of Clinical Oncology 2020 Virtual Scientific Program, and showed that both the primary and key secondary end points of ORR and CR rate were 75% and 33%, respectively. The median duration of response was 10.7 months, and the median progression-free survival was 8.8 months in all patients receiving ide-cel. Corresponding medians were 19.0 and 20.2 months among those achieving a CR or stringent CR. The median OS was 19.4 months in all treated patients.

The 128 patients treated received 1 of 3 target dose levels: 150, 300, or 450 106 CAR-positive T cells. The investigators noted that the highest efficacy outcomes were seen in patients in the 450 106 CAR-positive T-cell group, with an ORR of 82% and a 39% CR rate.

The incidence of CRS was 84% across the treatment cohort and increased with higher target doses. Overall, less than 6% of patients have grade 3 or higher CRS and only 1 patient in the highest target dose cohort had a grade 5 event. Neurological toxicity was low across target doses, with no grade 4 or 5 events reported.

At baseline, the majority of patients (51%) had high tumor burden, 39% had extramedullary disease, and 35% had high-risk cytogenetics including deletion 17p or translocations in t(4;14) or t(14;16).

In May, the FDA issued a refusal letter regarding the BLA for ide-cel because the Chemistry, Manufacturing, and Control (CMC) module required more information before they could complete the review.10 In September, the resubmitted application received a priority review and the agency assigned a PDUFA action date of March 27, 2021.11

If approved, ide-cel would be the first CAR T-cell therapy available for the treatment of patients with multiple myeloma.

References:

1. FDA approves brexucabtagene autoleucel for relapsed or refractory mantle cell lymphoma. FDA. Updated July 27, 2020. Accessed November 18, 2020. https://bit. ly/3pEDQV5

2. US Food and Drug Administration (FDA) accepts for priority review Bristol-Myers Squibbs biologics license application (BLA) for lisocabtagene maraleucel (liso-cel) for adult patients with relapsed or refractory large B-cell lymphoma. Press release. Bristol Myers Squibb. February 13, 2020. Accessed November 18, 2020. https:// bit.ly/37ruQbs

3. US Food and Drug Administration (FDA) accepts for priority review Bristol Myers Squibb and bluebird bio application for anti-BCMA CAR T cell therapy idecabtagene vicleucel (ide-cel, bb2121). Press release. Bristol Myers Squibb. September 22, 2020. Accessed November 18, 2020. https://bit.ly/3kDhakH

4. Wang M, Munoz J, Goy A, et al. KTE-X19 CAR T-cell therapy in relapsed or refractory mantle-cell lymphoma. N Engl J Med. 2020;382(14):1331-1342. doi:10.1056/ NEJMoa1914347

5. Abramson JS, Palomba ML, Gordon LI, et al. Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study. Lancet. 2020;396(10254):839-852. doi:10.1016/ S0140-6736(20)31366-0

6. Bachier CR, Palomba ML, Abramson JA, et al. Outpatient treatment with lisocabtagene maraleucel (liso-cel) in 3 ongoing clinical studies in relapsed/refractory (R/R) large B cell non-Hodgkin lymphoma (NHL), including second-line transplant noneligible (TNE) patients: Transcend NHL 001, Outreach, and PILOT. Paper presented at: 2020 Transplantation & Cellular Therapy Meetings; February 19-23, 2020; Orlando, FL. Abstract 29. Accessed November 18, 2020. bit.ly/37I7DC9

7. Bristol Myers Squibb provides update on biologics license application (BLA) for lisocabtagene maraleucel (liso-cel). Press release. Bristol Myers Squibb. May 6, 2020. Accessed November 18, 2020.https://bit.ly/2YFWAs8

8. Bristol Myers Squibb provides regulatory update on lisocabtagene maraleucel (liso-cel). News release. Business Wire. November 16, 2020. Accessed November 18, 2020. https://bwnews.pr/3pKQMZI

9. Bristol Myers Squibb and bluebird bio announce submission of biologics license application (BLA) for anti-BCMA CAR T cell therapy idecabtagene vicleucel (ide-cel, bb2121) to FDA. Press release. Bristol Myers Squibb. March 31, 2020. Accessed November 18, 2020. https://bit.ly/2JwKbxO

10. Bristol Myers Squibb and bluebird bio provide regulatory update on idecabtagene vicleucel (ide-cel, bb2121) for the treatment of patients with multiple myeloma. News release. Business Wire. May 13, 2020.Accessed November 18, 2020. https:// bwnews.pr/3cpgJa1

11. US Food and Drug Administration (FDA) accepts for priority review Bristol Myers Squibb and bluebird bio application for anti-BCMA CAR T cell therapy idecabtagene vicleucel (ide-cel, bb2121). Press release. Bristol Myers Squibb. September 22, 2020. Accessed November 18, 2020. https://bit.ly/3kDhakH

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Getting to the root of why hair goes gray – messenger-inquirer

By daniellenierenberg

Marco Kaltofen was 11 when he noticed his first white hairs. As his hair grew whiter, his middle-school friends started calling him the professor. By his mid-30s, it was completely white, as it had been for three of his grandparents. His parents went white in their 40s, so I had no chance of avoiding this, Kaltofen says.

Now 61, he is a civil engineer who lives in Boston. He wears his white hair in a ponytail. White hair is part of my identity, and I am completely at peace with it, he says.

Then there is Joe Rees, 75, a retired customs attache who lives in Washington. He is balding, but the hair that remains on the sides and in the back is the same dark brown it always has been. He jokingly attributes this to clean living and a pure heart, although, like Kaltofen, it probably is genetic. His mothers black hair didnt start to go gray until she was in her 70s, and was 50/50 when she died at 88, he says.

Still, Id rather be gray than bald, he says. That way, I wouldnt have to worry about wearing a hat all the time.

To be sure, Rees and Kaltofen are exceptions, since most people start graying in their 50s and 60s. Nevertheless, their experiences are among the many mysteries of gray, white or silver-looking hair that scientists are exploring to learn more about aging. They want to know why some people turn gray early and others late or not at all and what this might signal about their health. They also want to understand the factors that hasten graying, and even whether gray hair is reversible which could be a boon to those allergic to hair dye, or who hate spending money to keep the gray away.

Most important, studying gray hair could point to new approaches in promoting healthier aging, says Candace Kerr, health scientist administrator in the National Institute on Agings Division of Aging Biology.

While graying is one of the markers of aging aging is the ultimate risk factor for why hair goes gray it highlights the need for better understanding of the mechanisms that drive aging and age-related diseases, she says. To be able to target these pathways will be critically important for our aging population to live longer and happier lives.

Hair that looks gray, white or silver actually is colorless. Hair color comes from melanin, a pigment produced by cells in the hair follicles. Over time, these cells suffer damage and become depleted, losing their ability to make melanin. This results in new hair without pigment meaning, no color.

People use gray, white and silver interchangeably to describe hair that is turning or has turned. Its appearance whether it looks, gray, white or silver depends on how much natural color, or pigment, remains, experts say. Hair that has lost all its color typically appears white.

Studies have identified a number of factors that also may speed up gray hair, including smoking, diet, stress and genetics.

Our hair color depends on a set of specialized stem cells called melanocyte stem cells, and every time a new hair grows, these melanocyte stem cells have to divide in two and make a new melanocyte, [or] pigment cells, explains Melissa Harris, assistant professor of biology at the University of Alabama at Birmingham. These pigment cells stay in the base of your hair and their job is to produce pigment. These melanocytes reach out skinny arms, called dendritic processes, that shuttle the pigment to the hair shaft as it grows. So if all your melanocyte stem cells disappear, so do your melanocytes and so does your hair pigment. Thus gray hair.

Because stem cells directly influence hair color, studying gray hair can provide insights about why stem cells age and ultimately fail, offering important clues about the workings of other stem cells in the body for example, those found in muscles, bones and organs. In turn, these ultimately could point to whether gray hair could be a marker for disease, or the opposite, a longer life. Previous studies have not shown a relationship between life span and gray hair, including whether late onset of gray hair predicts longevity. Some research, however, indicates that gray or white hair can be a sign of early heart disease, regardless of age.

In some people, gray hair could potentially serve as indication of their health for instance when caused by stress, or a signal for those who may be developing cardiovascular disease, Kerr says. We still need to learn more about whether and, if so, how late onset of gray hair can signal better health and longevity in some people under certain circumstances, as well as whether early graying means stem cells might be aging.

There are many different stem cells in our body which may or may not age by different means, she says. How stem cells mark aging overall and how they could interact to promote aging is an important question.

This is why scientists who study gray hair regard it as a valuable research tool.

As gray hair researchers, we often have to defend why we study a cosmetic characteristic, rather than a life-threatening disease, Harris says. But what is very cool about gray hair from a scientific point of view is that we can see it with our own eyes, meaning we dont have to take invasive biopsies, and it doesnt kill you. We have asked a lot of important and interesting questions about stem cells by studying gray hair in mice. And, we are constantly on the lookout for gray-haired mice so we can use our scientific skills to find out what makes them gray.

A 2018 mouse study by Team Hair-Us (Harris nickname for her lab colleagues) found a connection between MITF (microphthalmia), a transcription factor (a protein involved in gene expression) important in managing pigment production, and the innate immune system, suggesting that some peoples hair may turn gray in response to serious illness or chronic stress. They discovered a relationship between genes involved in hair color and those that trigger an immune response to a viral infection, suggesting this interaction could increase the chances of developing gray hair.

MITF, in a sense, shields melanocyte stem cells from our own immune system, she says. Normally our immune system protects our bodies from infection. But for melanocyte stem cells, too much immune response is bad for their health, and this leads to their loss and to gray hair. Why melanocyte stem cells are so sensitive to our own natural means for protection, we still dont know.

Im very curious to see whether we see an uptick in individuals with gray hair due to coronavirus infection, she says. Unfortunately, we probably wont know because gray hair is rarely documented clinically, unless it is very extreme.

Scientists still dont know why some people turn gray early, late, or not at all, although they suspect genes, nutrients and possibly the immune system play a role in depleting melanocyte stem cells.

There is still much to learn about what regulates these stem cells and what may contribute to their loss, says Ya-Chieh Hsu, associate professor of stem cell and regenerative biology at Harvard University and principal faculty member of the Harvard Stem Cell Institute.

Among other things, Hsu studies the effect of stress on graying. Most of us are familiar with those before-and-after photographs of U.S. presidents most recently Barack Obama showing a striking increase in gray hair during their terms, even in relatively young presidents. Its known as the Marie Antoinette Syndrome, after the 18th-century French queen whose hair allegedly turned white overnight before she went to the guillotine and her death at age 38 during the French Revolution.

With the aging process, we gradually lose melanocyte stem cells one-by-one over a very long period of time, Hsu says. What we found in our research was that the stress can accelerate that process.

Hsu and her colleagues found that stress stimulates the same nerves that trigger the fight-or-flight response, which in turn causes permanent damage to the pigment-producing cells in hair follicles. The fight or flight response is thought to be a good thing in stressful situations because it can drive us and other organisms to respond to danger rapidly, Hsu says. This activation causes a spike in the neurotransmitter norepinephrine. Norepinephrine raises our heartbeat and allows us to react quickly to danger without having to think about it.

But norepinephrine also tells melanocyte stem cells to pump up their activity and proliferate, and too much norepinephrine, in this case triggered by stress, causes the melanocyte stem cells to burst into so much activity it leads to rapid depletion of the stem cell reservoir, she says. If all the stem cells are depleted, no more pigment-producing cells can be produced anymore, and the hair turns gray.

Other stress hormones, ACTH (adrenocorticotropic hormone) for example, can cause melanocyte stem cells to migrate away from the hair follicle before they can produce the melanocytes needed for hair and skin color, according to research. Such hormones are known to increase in the body after stress, and may have the potential to promote the loss of these cells, regardless of age, says study author Mayumi Ito, associate professor in the departments of cell biology and dermatology at the New York University Grossman School of Medicine.

Hsu believes the connection between stress and hair color could reveal additional information about how stress affects other biological processes. How stress affects our tissues is still poorly understood, and one of the powerful aspects about the melanocyte is that it provides a visible and highly trackable system to study stress, she says.

Ito also found that certain cell signaling proteins called endothelins (substances known to constrict blood vessels and raise blood pressure) bind to melanocyte stem cells and, in doing so, keep them healthy. Interrupting the process causes cell loss and early graying in mice. They are studying whether the same happens in human hair follicles, hoping to find ways to preserve or regenerate the key stem cells that give hair its color.

All of this raises the intriguing possibility that scientists could discover ways to prevent or reverse gray hair.

Team Hair-Us recently published a paper describing a topical drug combination that increased melanocyte stem cells in gray mice, ridding them of their gray and restoring their original fur color perhaps for good. Because the treatment originally developed to regrow hair replenished pigment-producing stem cells, the effects could be long-lasting, Harris says.

We didnt keep the mice forever so we dont know, says Harris, who plans more studies. This has made us very interested in whether gray hair really is permanent, and if we can do something about it. We really want to know and so does everyone else we talk to is whether and when we can bring this to humans.

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What causes chafing rash? Remedies, treatment, and prevention – Medical News Today

By daniellenierenberg

Chafing occurs when the skin rubs against something, such as clothing, for a prolonged period. The friction can cause a painful rash that typically resolves when the chafing stops.

A person can experience chafing on any part of the body that encounters friction. The resulting rash is often minor, but there are some possible complications.

In this article, we look at what causes chafing rash and how to treat it. We also look at how a person can prevent chafing from occurring.

A chafing rash occurs anywhere on the body where the skin is rubbing against clothing or other skin.

Mild chafing rashes tend not to be too painful, but more serious rashes could bleed, crust, or blister. Chafing can occur anywhere where there is friction, but some areas of the body are more prone to chafing than others.

Areas where chafing is most likely to happen are generally moist or generate friction. They include the:

The direct cause of chafing is the skin is rubbing against something for a prolonged period. This could happen, for instance, when someone is walking and their inner thighs are rubbing together.

Chafing is more likely to occur in particular areas of the body, and it tends to happen during physical activity, such as running.

Others causes of chafing include:

Additionally, an infant or toddler wearing a diaper may experience chafing due to the added moisture and movement in the area.

Learn more about the types of diaper rash here.

Chafing causes a burning or stinging rash to occur where the skin is rubbing against something. The rash will not spread to other areas.

Possible complications of chafing rashes include:

Bacteria could enter through the broken or damaged skin around a chafing rash and cause an infection. For that reason, a person should make sure that they take care of the rash and keep it clean. The Centers for Disease Control and Prevention (CDC) list several symptoms of a skin infection, which include:

Chafing rashes will typically clear up within a few days if a person stops the activity causing the chafing or takes action to prevent further chafing.

Excessive moisture and skin friction may lead to skin breakdown. Patting the skin dry to remove excess moisture may prevent complications of chafing rash.

A person may also wish to consider applying shea butter lotion to the rash. A 2012 study found that shea butter has anti-inflammatory properties, which could make it a good option for people who want to soothe a chafing rash with cream.

For pain, a person can try applying aloe vera to the skin, as it may soothe sore skin and help prevent infections.

People have also traditionally used a range of other plant oils, including olive oil and coconut oil, to treat skin-related issues. Further research is necessary to confirm the benefits of each of these oils.

Unless the skin becomes infected, doctors do not have a standard way of treating chafing rash. A person should avoid the activity that caused the chafing. If they cannot avoid the activity, they should take steps to prevent further chafing from occurring.

If a person needs treatment, a doctor may prescribe or recommend a corticosteroid cream or ointment to help reduce the inflammation resulting from the rash.

It is not always possible to prevent chafing from occurring, but a person can take certain steps to reduce the risk.

According to the American Academy of Dermatology Association, these steps include:

Other steps a person can take to help prevent chafing include:

Additionally, the findings of an older study suggest that a person can apply petroleum jelly to the skin to minimize friction and prevent chafing rash.

If a person develops a rash that spreads, it is likely not a chafing rash. A person should consider seeing their doctor if the rash does not go away within a few days of home treatment.

A person should also talk to their doctor if they suspect that their rash has become infected. A doctor can examine the rash and determine whether additional treatment is necessary.

A chafing rash is often a mild rash that occurs when skin rubs against clothing or other areas of skin. Many cases are mild and will go away when a person stops the activity causing the chafing.

A possible complication of chafing rash is a skin infection. A person should speak with their doctor if the rash is severe or they think that it has become infected.

At-home treatments for chafing rash include aloe vera and other soothing ointments. A person can take preventive steps to reduce the risk of a rash forming, such as wearing moisture-wicking clothing and applying petroleum jelly to areas prone to chafing.

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Rash on black skin: Pictures, symptoms, and treatments – Medical News Today

By daniellenierenberg

Rashes can appear differently on different skin tones. For example, a heat rash on darker skin may look like a series of gray or white spots, while many medical sources describe them as red.

It is crucial for medical professionals to understand how health issues can present on the full range of skin tones. A lack of this understanding can lead to misdiagnoses.

It is generally advisable to contact a doctor about any rash that lasts longer than a week. The Skin of Color Society offer a database of dermatologists in the United States who have experience treating conditions in people of color.

In this article, we explore what rashes can look like on skin of color. We also describe the symptoms and treatments of specific issues.

The appearance of a rash varies with skin tone. On skin of color, a rash may be purple, gray, or white while medical texts often simply describe these rashes as red. Some redness may appear, but typically not very much.

This is due to melanin, a molecule that gives the skin and hair their color. Generally, the more melanin a person has in their skin, the darker their skin tone. It affects how the skin reacts to sunlight, damage, and health conditions that cause rashes.

Some doctors are unaware of how skin conditions present on darker skin. A 2018 study of four major medical textbooks found that darker skin tones were underrepresented in the imagery.

The studys authors report that while, at the time, 20.4% of the U.S. population was Black, only 4.5% of the photographs in the textbooks showed people with dark skin. They suggest that this is likely an example of racial bias in the healthcare system.

Below, we explore how various health issues can appear in skin of color.

Heat rash, sweat rash, and prickly heat are all common names for miliaria, a skin condition that occurs when the skins sweat ducts become blocked.

The symptoms of heat rash include:

On darker skin, the blisters may be gray or white.

This rash often occurs due to heat and humidity, but intense exercise, nonbreathable clothing, and medical dressings can also cause it. The condition typically improves within 12 days.

Cooling down, wearing more breathable clothing, and changing or, if recommended, removing dressings can help.

Eczema causes patches of dry, itchy skin, and the affected area may also be flaky or scaly. If the skin is very dry, it may crack or bleed.

In darker skin tones, patches of eczema may be red, pink, magenta, or darker than surrounding skin.

Eczema is also more likely to form in specific ways in people of color. For example, there is a higher chance that the rash may be papular, characterized by a series of small bumps like goosebumps.

There are several types of eczema, including:

This occurs when the skin comes into contact with an irritant, such as poison ivy, nickel, or fragrance. The skin may itch, sting, burn, or blister.

People with certain jobs have a higher risk of contact dermatitis. These jobs may involve regular contact with chemicals, food, or water. People with a higher risk may include:

Avoiding contact with the trigger, such as a specific chemical, is the best approach. A dermatologist can also describe products that can help and perform skin allergy testing to identify the trigger.

Atopic dermatitis is eczema with no clear cause. The condition often begins in childhood and may not last into adulthood. In the U.S., it appears to be more common among African Americans, Asian Americans, and Pacific Islanders than other groups.

There is no cure for atopic dermatitis, but there are ways of alleviating and preventing the rash from forming.

This typically involves using a non-irritating moisturizer regularly, after bathing or showering. It is also important to avoid fragranced products, food allergens, and irritating fabrics, such as wool. In addition, a person may need a topical corticosteroid, which a doctor can recommend or prescribe.

Learn more about eczema on black skin and its treatments.

Psoriasis is a long-term inflammatory condition that causes thickened patches of skin. On skin of color, these patches may be red or violet and have a top layer of silver or gray scales.

In the U.S., psoriasis is more common in white people than Black people. However, in Black people, it may be more likely to cover larger areas of the body.

Psoriasis can affect the nails as well as the skin, and a significant portion of people with psoriasis also have arthritis.

There is no cure, but it is possible to manage the symptoms. Among the range of options are:

Learn more about psoriasis on black skin and its treatments.

Lichen planus causes a series of bumps to form on the skin. Each bump is shiny, raised, and has a flat top. On skin of color, these bumps may be gray-brown or purple.

The most commonly affected areas are the back, neck, lower legs, ankles, and the insides of the wrists. In 20% of cases, lichen planus causes no symptoms beyond the bumps, but in others, it causes intense itching.

Lichen planus can last for months or years, and there is no known cure. Treatments that can relieve the symptoms include:

Learn more about the causes and treatments of lichen planus.

Vitiligo is a condition that causes patches of skin to lose its color, or become depigmented. If the condition affects areas with hair, the hair may turn white, too.

The condition occurs when the immune system attacks melanocytes, the cells that produce melanin. Scientists are not sure why this happens, but they believe that it could stem from an autoimmune response.

Areas commonly affected by vitiligo include:

Vitiligo can affect anyone, but it is more noticeable in people with darker skin. People with vitiligo are more likely to have a family history of autoimmune disorders.

The depigmentation often stops or slows over time. Treatments focus on reducing the spread of depigmentation and restoring color to the skin. This may include the use of medicated creams or light therapy.

Shingles is caused by the same virus as chickenpox. Anyone who has had chickenpox can develop shingles later on. One symptom that most people with shingles develop is a rash of small blisters.

The symptoms of shingles are:

Some people also experience a fever, headaches, muscle aches, stomach pain, or nausea and vomiting.

On highly pigmented skin, a shingles rash may be red, the same color as the skin, or slightly darker. The scabs may be grey.

While the rash often heals within 24 weeks, it is important for anyone with shingles symptoms to see a doctor for treatment within 23 days. This is because shingles can cause long-term complications.

The doctor can prescribe antiviral medication, which can reduce the risk of complications and shorten the healing time.

Ringworm is a fungal infection of the skin. It often causes a round or ring-shaped rash with a raised border, though the rash may be shaped differently on certain areas, such as the feet or hands.

On darker skin, the ringworm rash is often gray or brown.

Ringworm is contagious, so it is important to seek treatment right away and avoid touching the rash, even if it is itchy.

Other names for this infection include:

Treatment may involve antifungal cream or, if the rash covers a large area, oral medication.

The best approach to treatment at home depends on the cause of the rash. But there are some general strategies for preventing further irritation, such as:

It is also important to protect the skin from sun damage with a product that contains SPF 30 or higher. UV light can also worsen skin irritation for people with certain conditions.

In some cases, a rash signals a medical emergency. Seek urgent medical attention if a rash:

Anyone who may have shingles or ringworm should see a doctor promptly to prevent transmission. For shingles, a person should wait no more than 23 days.

Otherwise, it is generally a good idea to contact a doctor if any rash lasts longer than a week.

The Skin of Color Society provide a database of dermatologists in the U.S. who have experience treating conditions in people of color.

In skin of color, a rash may be red, brown, purple, or gray.

Some doctors may misdiagnose skin issues in people of color due to a lack of awareness. Skin of color is often underrepresented in medical texts.

A dermatologist who understands how rashes present in the full range of skin tones is best prepared to provide the right treatment.

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Everything You’ve Ever Wanted to Know About Body Hair – Allure

By daniellenierenberg

As for your lips, we dont grow hair there because our lips are made up of a different type of cell, as theyre considered to be an extension of the gastrointestinal (GI) tract, says Mariwalla.

If having hair is so crucial to the function of our bodies, why have we been removing it for hundreds of years? Well, we have no one to blame but ourselves. We have, through communication with one another, established a globalized practice of removing hair to make women especially look very smooth and have baby-like skin; and for men to retain their body hair, says Jablonski. We tend to think, Oh, these signals are very ancient. These practices are very ancient. They're not. This is a pretty recent obsession. Jablonski estimates the practice of body hair removal started about only 500 years ago.

While modern societal standards of what femininity and masculinity are still very much linked to hairiness or lack of hairiness, weve begun to see a shift in the acceptance and normalization of body hair, thanks in part to social media, which has even helped us celebrate body hair for the first time. (Remember #freeyourpits?)

It's really wonderful when people examine those social norms and say, hold on, who started this? This is a bunch of nonsense, says Jablonski. And they realize, Hey, I can be a beautiful person inside and out without following these practices. It is tremendously liberating.

That sense of celebration seems to be more prevalent than ever before, as were living through a pandemic, which has put physical interactions between people on pause. Because of this, many of the performances we put on for others, like body hair removal, have become one-woman shows, with one-woman audiences.

So then you realize, in your heart of hearts, this is a waste of time, says Jablonski. Why should I take this time to do this thing that is socially acceptable and allows me to cleave towards a social norm? I'm doing just fine. People feel a lot of freedom now.

Of course, if you do choose to remove your body hair and thats fine too! depending on the location of the hair, there are a number of methods that will get the job done, says Mariwalla.

Shaving

For starters, theres shaving, the act of removing hair with a razor. When you shave the hair on your body (typically on the legs, underarms, and face), youre removing hair from above the top layer of skin, says Mariwalla. She recommends shaving with a cream or gel to keep the skin hydrated. The process of shaving is almost like exfoliating that top layer of skin, she says. So, it's like a two for one.

Tweezing

Tweezing, on the other hand, pulls the hair directly from the follicle. When you think about a hair follicle, it's like the little house that your hair lives in, explains Mariwalla. Any time you pull a hair from a follicle, it's always going to grow back. But its going to take longer than when you only remove it from above the skin.

Waxing and Sugaring

Waxing and sugaring use the same mechanism as tweezing but with warm substances (i.e. wax and sugar) that sit on top of the skin and around the hair to coax it out of the follicle. Its a process that is trying to warm the skin, so that the hair follicle opens up a little bit and the wax solidifies around the hair, says Mariwalla. When you remove the wax you basically rip the hair out of the follicle as you're doing it.

Depilatory Cream

There are also depilatory creams. Instead of grabbing onto the hair and pulling it, you're putting on a chemical that's dissolving the hair at the root, explains Mariwalla. So then you basically then just wipe it away.

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2020 in Neuroscience, Longevity, and AIand What’s to Come – Singularity Hub

By daniellenierenberg

Covid-19 sucked most of the oxygen out of science this year. But we still had brilliant wins.

The pandemic couldnt bring rockets or humans down: multiple missions blasted off to the red planet in the summer of Mars. Two astronauts launched to the International Space Stationand made it safely backin a game-changer for commercial space travel. NASA released dozens of findings on how space travel changes our bodies, paving the way to keep us healthy in orbitor one day, on Mars and beyond.

Back on Earth, scientists scoured mud ponds and fished out a teeny-tiny CRISPR enzyme that packs a massive punch for genome editing. AI and neuroscience became even more entwinedsometimes literally. Biological neurons got hooked up to two silicon-based artificial neurons, across multiple countries, into a fully-functional biohybrid neural network. Others tapped dopaminethe main messenger for the brains reward systemto unite electricity and chemical computing into a semi-living computer. While still largely a curiosity, these studies take brain-inspired computers to another level by seamlessly incorporating living neurons into AI hardware. Now imagine similar circuits inside the brainNeuralink sure is.

More abstractly, biological and artificial brains further fed into each other in our understandingand craftingof intelligence. This year, scientists found mini-computers in the input tree-like branches of neurons. Like entire neural networks, these cables were capable of performing complex logical calculations, suggesting our brain cells are far brainier than we previously thoughtsomething AI can learn from. On the flip side, a hotshot algorithm inspired by the brain called reinforcement learning pushed neuroscientists to re-examine how we respond to feedback as we learn. AI also helped build the most dynamic brain atlas to date, a living map that can continuously incorporate new data and capture individual differences.

As we leave 2020 behind, two main themes percolate in my mind, not just for what theyve accomplished, but as indicators of what lies ahead. These are the trends Ill be keeping my eyes on in the coming year.

Why we age is extremely complex. So are methods that try to prevent age-related diseases, or slow the aging process itself. This nth-dimensional complexity almost dictates that longevity research needs to self-segregate into lanes.

Take probing the biological mechanisms that drive aging. For example, our cells energy factory spews out bullet-like molecules that damage the cell. The genome becomes unstable. Cells turn zombie-like. Working stem cells vanish. Tissue regeneration suffers. Scientists often spend entire careers understanding one facet of a single hallmark of aging, or hunting for age-related genes. The lucky ones come up with ways to combat that one foefor example, senolytics, a family of drugs that wipe out zombie cells to protect against age-related diseases.

But aging hallmarks dont rear their heads in isolation. They work together. An increasing trend is to unveil the how of their interactions workcrosstalk, in science-speakwith hopes of multiple birds with one stone.

This year, longevity researchers crossed lanes.

One study, for example, took a stem cell playbook to rejuvenate eyesight in aged mice with vision loss. They focused on a prominent aging hallmark: epigenetics. Our DNA is dotted with thousands of chemical marks. As we age, these marks accumulate. Using gene therapy, the team introduced three superstar genes into the eyes of aged mice to revert those marks and reprogram cells to a younger state. Youve probably heard of those genes: theyre three of the four factors used to revert adult skin cells into a stem-cell-like state, or iPSCs (induced pluripotent stem cells). Resetting the epigenetic clock was so powerful it improved visual acuity in old mice, and the team has now licensed the tech to Life Biosciences in Boston to further develop for humans.

Another study combined three main puzzle pieces in agingzombie cells, inflammation, and malfunctioning mitochondriainto a full picture, with the surprise ending that senolytics has multiple anti-aging powers in cells. Talk about killing two birds with one stone. Finally, one team (which I was a part of) combined two promising approaches for brain rejuvenationexercise and young bloodto begin pushing the limits of reigniting faltering memory and cognition due to aging.

Longevity research has long been fragmented, but its starting to coalesce into a multidisciplinary field. These crossovers are just the start of a rising trajectory to combat the multi-headed Hydra thats aging. More will come.

If youre looking for a sign that AI is leaving the digital realm of Atari games and heading into the real world, this year was it.

In biotech, theres no doubt of AIs promise in drug discovery or medical diagnoses. In late 2019, a team used deep learning and generative modelssimilar to AlphaGo, the DeepMind algorithm that trounced humans at Go and wiped the Atari libraryto conjure over 30,000 new drug molecules, a feat chemists could only dream of. This year, the viral hurricane thats Covid-19 further unleashed AI-based drug discovery, such as screening existing drugs for candidates that may work against the virus, or newlydesigned chemicals to fight off SARS-CoV-2 infectionthe virus that causes Covid-19.

For now, we dont yet have an AI-designed drug on the market, an ultimate test for the technologys promise. However, although AI wasnt able to make a splash in our current pandemic battle, the scene is set for tackling the next oneand drug discovery as a whole.

In contrast, AI-based medical diagnosis had a resounding win. This year, the FDA approved a software that uses AI to provide real-time guidance for ultrasound imaging for the heart, essentially allowing those without specialized training to perform the test. The approval brings a total of 29 FDA-approved AI-based medical technologies to date. Even as the debate on trust, ethics, and responsibility for AI doctors cranked up in temperature, the Pandoras box has been opened.

Medicine aside, deep learning further honed its craft in a variety of fields. The neuroscience-AI marriage is one for the ages with no signs of fracture. Outside the brain, AI also gave synthetic biology a leg up by parsing the interactions between genes and genetic networksa mind-bending, enormously complex problem previously only achieved through trial and error. With help from AI, synthetic biologists can predict how changes to one gene in a cell could affect others, and in turn, the cells biochemistry and behavior. Bottom line: it makes designing new biological circuits, such as getting yeast to pump out green fuels or artificially hoppy beer, much easier.

But the coup de grce against AI as an overhyped technology is DeepMinds decimation of a 50-year-long challenge in biology. With a performance that shocked experts, DeepMinds AlphaFold was able to predict a proteins 3D structure from its amino acid sequencethe individual components of a proteinmatching the current gold standard. As the workhorses of our bodies, proteins dictate life. AlphaFold, in a sense, solved a huge chunk of the biology of life, with implications for both drug discovery and synthetic biology.

One more scientific brilliance this year is the use of light in neuroscience and tissue engineering. One study, for example, used lasers to directly print a human ear-like structure under the skin of mice, without a single surgical cut. Another used light to incept smell in mice, artificially programming an entirely new, never-seen-in-nature perception of a scent directly into their brains. Yet another study combined lasers with virtual reality to dissect how our brains process space and navigation, mentally transporting a mouse to a virtual location linked to a reward. To cap it off, scientists found a new way to use light to control the brain through the skull without surgerythough as of now, youll still need gene therapy. Given the implications of unauthorized mind control, thats probably less of a bug and more of a feature.

Were nearing the frustratingly slow, but sure, dying gasp of Covid-19. The pandemic defined 2020, but science kept hustling along. I cant wait to share what might come in the next year with youmay it be revolutionary, potentially terrifying, utterly bizarre* or oddly heart-warming.

* For example, Why wild giant pandas frequently roll in horse manure. Yes thats the actual title of a study. Yes, its a great read. And yes, its hilarious but has a point.

Image Credit: Greyson Joralemon on Unsplash

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Hair loss, body odor, irregular periods: Covid-19 isolation does weird things to our bodies – Vox.com

By daniellenierenberg

I am seeing tons of hair loss, Mona Gohara says.

Patients come to Gohara, a dermatologist and professor at the Yale School of Medicine, for all kinds of reasons from skin cancer screenings to cosmetic procedures. But this year more than ever, theyre worried about their hair.

Its not a coincidence. Stress like, say, that brought on by living through a deadly pandemic is known to cause hair loss. Ordinarily, 90 percent of the hairs on our head are in the growing cycle; 10 percent are in the shedding cycle, Gohara explained. But when were subject to some type of physiologic or emotional stress, that cycle shifts to where the shed outweighs the grow. The result: people notice a massive, massive shed.

And those stray hairs are part of a bigger trend. At this point, millions of Americans have spent nine months living through a public health nightmare and an unprecedented economic crisis at the same time. They have also had to cope with all this while avoiding gatherings, limiting physical contact, and, when possible, staying inside their homes. Put together, the isolation and anxiety of life in 2020 have brought with them numerous side effects. For one, they might be doing weird things to our bodies.

If youve noticed your menstrual cycle is more irregular this year, for example, youre not alone: More patients are reporting irregular periods since the pandemic began, Mary Jane Minkin, an OB-GYN who teaches at the Yale School of Medicine, told Vox. The likely culprit, as with hair loss, is the anxiety of living in such a difficult and uncertain time. When stressors come into play, Minkin said, we end up with screwy periods.

If youve spotted more gray hairs on Zoom calls, there may be a pandemic-related explanation for that too. And according to some, life in lockdown may even be changing peoples body odor.

Those are just some of the smaller effects. Some experts are also concerned because isolation has documented effects on health, increasing the risk of cardiovascular disease and even death. Humans are considered a social species, Julianne Holt-Lunstad, a professor of psychology and neuroscience at Brigham Young University who studies the impact of social relationships on health, told Vox. When we lack proximity to others, and particularly trusted others, this creates a heightened state of alert or stress which, over time, can have harmful effects on our bodies.

To be clear, none of this is an argument for getting rid of pandemic-related restrictions after all, the effects of Covid-19 on the body can be far more severe than the effects of isolation.

But the rise of pandemic periods, weird smells, and other bodily indignities are a reminder that Americans are going through something right now that most of us have never experienced before. And that takes its toll in a lot of ways some of them stranger than others.

Lets talk about periods first. Trend pieces about menstrual changes either irregularity or worsened symptoms like cramps began popping up in the spring. A couple of weeks into the stay-at-home order in Washington State, where I live, I woke up in the middle of the night with the worst cramps Ive ever had, Colleen Stinchcombe wrote at Self in May.

And while its likely too soon for any published research on the impact of the pandemic on menstruation, Minkin isnt the only one to see increased reports of irregularity among her patients. Its common for us to see patients with changes in their menstrual cycle, but anecdotally, it seems like its been happening more over the last six months, Beth Schwartz, an OB-GYN at Thomas Jefferson University Hospital in Philadelphia, told the Washington Post in August.

These changes arent necessarily surprising, Minkin told Vox. Most people think that the ovaries and the uterus regulate periods, she said. But actually, the boss is sitting in our brain.

Specifically, its the hypothalamus and the pituitary gland that control the ovaries, regulating their hormone production, which in turn regulates the menstrual cycle. Its our nice, regular hormonal activity from the hypothalamus and the pituitary which stimulate the ovaries to do their thing appropriately and get us nice, regular periods, Minkin said.

And when were under stress, that can disrupt the functioning of the hypothalamus and pituitary, leading to irregularity. Researchers have noticed a similar effect among young people who go away to college and often experience irregular periods as they adjust to a new environment and a new set of worries and pressures.

The good news, Minkin said, is having an irregular period generally isnt dangerous. When her patients report irregularity, shell typically test their thyroid function and levels of certain hormones to rule out conditions like polycystic ovary syndrome, but as long as everythings normal, no treatment is needed. If the irregularity is especially bothersome, people can take hormonal contraception to regulate their periods, Minkin said. Once we get through things and peoples lives get back toward normal, most folks are probably going to regulate themselves just fine.

But irregular periods arent the only strange symptom people are reporting after months of reduced contact with others. Another is body odor some say theyve started to smell worse, or just different, since the pandemic began.

I am a man who prides himself on smelling fresh and fancy free at all times, Joseph Lamour wrote at Mic in July. But during the pandemic summer, he became so limburger-esque that my own odor woke me up in the middle of the night.

As with periods, theres not yet published research on changes in body odor during the pandemic. But anecdotal reports of the issue have gotten back to Julie Horvath, head of the Genomics and Microbiology Research Lab at the North Carolina Museum of Natural Sciences and a professor at North Carolina Central University. An expert in primate genetics who expanded into studying microbes and odor (I never thought I would be the armpit researcher, she says), Horvath explains that a big factor in the way we smell is our skin microbiome, or the mix of bacteria, fungi, and viruses that live on our skin.

When youre in your home, youre now coming into contact more with maybe your pets and your family, who you didnt see as many hours a day, she told Vox. This means were exchanging microbes with a different group of people (and animals) than usual, which could affect our smell. Spending more time indoors can also affect the microbiome, as can wearing different types of clothes synthetic fabrics can host different kinds of microbes than cotton, for example. And a lot of people have changed their style (if you can call it that anymore) during the pandemic. When I talk to people, maybe theyre wearing a nice shirt, but now they have jeans or sweatpants on, Horvath said.

Stress can also affect the microbiome, Horvath said. A specific set of glands, the apocrine glands, release sweat when youre nervous. That sweat contains different compounds from sweat that comes from the ecrine glands, which get to work when youre too hot. And if your apocrine glands found in the armpit and a few other places on the body are highly active, then they are providing a different food source to some of those microbes there, and maybe youre promoting the growth of some that smell different than what they wouldve before, Horvath said.

But the microbiome doesnt just affect the way we smell. Beneficial bacteria on our skin create a protective barrier, Horvath explained. If you have these good, beneficial microorganisms that are on your skin, eating oil or sweat and living there happily, theyre taking up residence, she said. Then, if something lands on your skin that can make you sick a staph bacterium, for example then it cant take hold very quickly, because your beneficial organisms are going to outcompete it for resources.

Washing your hands with soap and water just washes away the lop layer of microbes, potentially allowing some of the good ones to stick around. But hand sanitizer kills the microorganisms on your skin, the good along with the bad, Horvath said. Thus, using too much hand sanitizer during the pandemic could leave us more vulnerable to staph, acne, or other infections down the road.

Airborne spread of the coronavirus in close contact is the main danger in the pandemic, but we still need to wash our hands, too. Horvath recommends using soap and water when possible to help maintain a healthy microbiome. Beyond that, habits like eating a healthy diet could be good for your microbial balance, though they may or may not help you smell better. Spending time outside if you can is also a good idea, Horvath said. Certain organisms that are outside in the soil are actually beneficial for your overall body.

Beyond weird smells and irregular periods, the isolation of this year has brought with it other physical changes for many. In addition to hair loss, a proliferation of gray hair is a common complaint one that can also likely be pinned on stress, as Deanna Pai reports at Medium. While the mechanism by which stress causes graying isnt fully understood, one recent study in mice found that stress led to the death of stem cells that produce melanocytes, the cells in hair follicles that produce pigment.

Gray hair isnt reversible (except with dye), Pai points out, but managing stress as much as anyone can during a pandemic can help slow the process.

Stress could also be making our skin look worse, Gohara, the dermatologist, said. It causes an increase in the hormone cortisol, which wreaks cosmetic havoc on your skin and can lead to anything from dryness to puffy eyes, she explained. Everything just looks worse with a surge in cortisol.

An increase in stress can also lead to more acne, something also exacerbated by the friction of wearing a mask (hence the 2020 neologism maskne, or breakouts on the lower part of the face linked to mask-wearing). Luckily, unlike gray hair, much of this is reversible you can combat maskne by washing masks in the same gentle cleanser you use for your face, Gohara said, and using a product with salicylic acid or benzoyl peroxide. For hair loss, meanwhile, she sometimes prescribes supplements, but also reassures patients that when it comes to shedding, eventually the cycle is going to re-equilibrate itself and your hair will be back on track.

While things like hair loss are typically harmless, if annoying, the way we live in 2020 could be causing more serious issues too.

Researchers have long known that isolation the condition of having little or no contact with other people and loneliness the subjective feeling of being alone, regardless of how much contact with people one has can be harmful, Holt-Lunstad, the psychologist, said. For example, in one 2015 analysis, she and her coauthors found that isolation was associated with a 29 percent increased likelihood of mortality, while loneliness was associated with a 26 percent increase.

There are a couple of ways that loneliness can potentially hurt our health. For one, friends and loved ones can influence us to take better care of ourselves having someone who encourages you to get to bed, or eat fruits and vegetables, or quit smoking, is good for our health, Holt-Lunstad said.

But many studies actually control for lifestyle factors like smoking and diet, and still find that loneliness and isolation have a negative effect. One reason, some researchers believe, is that our brains have adapted to expect proximity to others, and particularly trusted others, Holt-Lunstad said. When they arent around, the brain signals other parts of the body to go into a heightened state of alert. That can lead to changes in heart rate and blood pressure that could increase our risk of cardiovascular disease. But it could also lead to systemic inflammation in the body, which in turn has been linked to a host of mental and physical problems, Holt-Lunstad said, from Alzheimers disease to, troublingly, increased susceptibility to viruses.

These impacts are especially concerning because some early research has found high rates of loneliness and isolation during the pandemic. In an August survey, for example, two-thirds of adults reported social isolation, and more than 7 in 10 said the pandemic had made it harder to connect with friends.

Luckily, there are ways to reduce isolation, even during a time of social distancing. In a study this summer sponsored by the neighborhood-focused social network Nextdoor, Holt-Lunstad and her colleagues found that performing small acts of kindness for neighbors, such as bringing them groceries or checking in on them over the phone, was associated with a significant drop in loneliness 1 in 10 participants felt lonely at the beginning of the study, while just 1 in 20 felt the same at the end.

But it cant all be on individuals to fix their isolation during this very lonely time. Instead, Holt-Lunstad has advocated for policymakers to pay more attention to peoples social needs throughout the pandemic and recovery, including increased funding to help students and older people, who may be especially vulnerable to loneliness right now. And while funding for anything remains a fraught subject in Congress, Holt-Lunstad writes at Health Affairs that decisions should be based on scientific evidence of benefits and drawbacks to our well-being, not solely on economic costs and convenience.

Some of the smaller effects of pandemic living may dissipate naturally when this time in our lives is over. When it comes to issues like irregular periods, for example, the biggest takeaway is dont panic, Minkin says. We will get back to normal.

But for other, larger problems, like isolation and its serious effects on the body, the pandemic could be a wake-up call. My hope is now that we have all experienced, in some degree or another, this feeling of isolation and loneliness, that there may be greater awareness and less stigma, Holt-Lunstad said.

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Organ and Tissue Transplantation and Alternatives – GlobeNewswire

By daniellenierenberg

New York, Dec. 21, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Organ and Tissue Transplantation and Alternatives" - https://www.reportlinker.com/p096592/?utm_source=GNW g., kidneys, liver, heart-lung, pancreas, intestines) and the tissue transplantation (e.g., bone, skin, cornea, heart valve) markets, along with the pharmaceuticals that accompany each market.

Also included are experimental xenografts and artificial organs; tissue transplants; and cell transplants (e.g., bone marrow, cord blood, peripheral blood, islet cell). The report touches on the use of fetal cells, stem cells and altered cancer cells.

The arrangement of this report offers an overview of the key elements in the transplantation process: tissue typing, procurement and preservation, immunosuppressants for solid organ and tissue transplants, and postoperative monitoring. International markets are discussed, and information is provided on industry structure and the regulatory environment.

Within each section are discussions of commercialization opportunities for each segment of the market. New or emerging devices, techniques and pharmaceuticals are highlighted.

Profiles of leading companies involved with solid organ transplantation, tissue transplantation, and alternative technologies are included. The report provides information on company placement within the market and strategic analyses of the companies available and emerging products.

An appendix featuring various terms and processes used in transplantation is provided at the end of the report.

This report cites autologous products only in relation to their impact on the market for allografts. It does not include blood products, except for peripheral and umbilical cord blood as a source of stem cells.

By geography, the market has been segmented into the North America, Europe, Asia-Pacific, and Rest of the World regions. Detailed analysis of the market in major countries such as the U.S., Germany, the U.K., Italy, France, Spain, Japan, China, India, Brazil, Mexico, GCC countries and South Africa will be covered in the regional segment. For market estimates, data will be provided for 2019 as the base year, with estimates for 2020 and forecast value for 2024.

Report Includes:- 26 data tables and 37 additional tables- An overview of the global organ and tissue transplantation and alternatives market- Estimation of the market size and analyses of market trends, with data from 2018 to 2019, estimates for 2020 and projection of CAGR through 2024- Details about organ and tissue transplantation and alternatives, their pathophysiology and affects, and major advancement and latest trends- A look at the regulatory scenarios and initiatives by government organization- Analysis of current and future market dynamics and identification of key drivers, restraints and opportunities such as increasing incidence of organ donations, improved awareness about organ donations, side effects of organ and tissue transplantation and antibiotic resistance infections- Coverage of emerging procedures and products in development and discussion on prevalence of major chronic diseases which initiates organ damage or donation- Discussion on the role of the organ procurement organization and information on transplantation process and preparation and coverage of issues like black market donors- Impact analysis of COVID-19 on organ and tissue transplantation and alternatives market- Market share analysis of the key companies of the industry and coverage of events like mergers & acquisitions, joint ventures, collaborations or partnerships, and other key market strategies- Company profiles of major players of the industry, including Abiomed Inc., Bayer AG, F. Hoffmann-La Roche & Co., Johnson & Johnson, Novartis AG, Pfizer Inc. and XVIVO Perfusion

Summary:The global organ and tissue transplantation and alternatives market was valued at REDACTED in 2019.The market is expected to grow at a compound annual growth rate (CAGR) of REDACTED to reach approximately REDACTED by 2024.

Growth of the global market is attributed to factors such as the growing prevalence of obesity, diabetes, cancer, and other chronic diseases which leads to organ damage, a strong product regulatory scenario, and strong investment in research and development activities by key market players including Abbott Laboratories, Cryolife Inc., Bristol-Myers Squibb, Novartis Ag, F. Hoffmann-La Roche Ltd., Medtronic, Arthrex Inc., Depuy Synthes (Johnson & Johnson), and Allosource.

Although various factors facilitate the global market for organ and tissue transplantation and alternatives, certain parameters such as challenges in HLA sequencing and gaps in supply and demand can constrain market growth.For instance, although there is an increasing need for organ transplants, the shortage of organs worldwide limits the number of transplant procedures performed, and in turn creates an impact on transplant diagnostics procedures.

An increasing number of candidates on the waiting list for organ transplant procedures worldwide further widens this gap of availability and requirement of organs for transplant purposes.

Successful organ and tissue transplantation began to arrive in the mid-1970s when tissue typing coupled with the use of cyclosporine provided more successful graft and patient survival. Today, patient and graft survival for kidney transplants is higher than 90% for the first year post-transplant, and often the success rate is 80% to 90% for five years post-transplant, with some recipients living more than 20 years after their transplant.

Continuing developments in organ procurement, organ preservation, tissue typing, and immunosuppressant use have bolstered successful transplantation surgical techniques. Evolving posttransplant drug and testing regimens have added to the success rate with close post-transplant monitoring and immunosuppressant dosage review.Read the full report: https://www.reportlinker.com/p096592/?utm_source=GNW

About ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

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FDA Resumes eIND Approval for Severe-to-Critical COVID-19 Patients Use of Vyrologix (leronlimab) Following Full Enrollment in CytoDyn’s Phase 3 Trial…

By daniellenierenberg

FDAs decision will enable CytoDyn to respond to ongoing requests for leronlimab until Phase 3 trial data is unblinded

VANCOUVER, Washington, Dec. 22, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company"), a late-stage biotechnology company developing Vyrologix (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today a treating physician has received authorization from the U.S. Food and Drug Administration (FDA) to administer leronlimab for a COVID-19 patient under emergency IND (eIND).

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, We are very thankful the FDA is allowing severe-to-critical COVID-19 patients access to Vyrologix (leronlimab) again under eIND while we await the unblinding of data from our recently completed Phase 3 registrational trial. We are receiving daily requests from families seeking our drug for a loved one with COVID-19. In recent months, leronlimab received more than 60 eIND authorizations from the FDA, and during the pendency of our COVID-19 trials, we deferred seeking authorizations for eINDs in order to accelerate the pace of enrollment. Now that enrollment has been completed, we are pleased to be able to assist once again and remain hopeful the upcoming results of our Phase 3 trial will enable leronlimab to be more readily available for severe-to-critical COVID-19 patients.

CytoDyns Phase 2b/3 trial to evaluate the efficacy and safety ofleronlimabfor patients with severe-to-critical COVID-19 indications is a two-arm, randomized, double blind, placebo controlled, adaptive design multicenter study. Patients are randomized to receive weekly doses of 700 mg leronlimab, or placebo. Leronlimab and placebo are administered via subcutaneous injection. The study has three phases: Screening Period, Treatment Period, and Follow-Up Period. The primary outcome measured in this study is: all-cause mortality at Day 28. Secondary outcomes measured are: (1) all-cause mortality at Day 14, (2) change in clinical status of subject at Day 14, (3) change in clinical status of subject at Day 28, and (4) change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14.

About Coronavirus Disease 2019 CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a double-blinded, randomized clinical trial for mild-to-moderate patients in the U.S. which produced statistically significant results for NEWS2. CytoDyn completed enrollment of 390 patients in its Phase 2b/3 randomized clinical trial for the severe-to-critically ill COVID-19 population and expects to release results in mid-January 2021.

About Leronlimab (PRO 140) The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first indication is a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH.Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells.CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD. Due to the lack of patients during the COVID-19 pandemic, the Company is closing down its Phase 2 trial for acute GvHD.

About CytoDyn CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH.

CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. The FDA met telephonically with Company key personnel and its clinical research organization and provided written responses to the Companys questions concerning its recent Biologics License Application (BLA) for this HIV combination therapy in order to expedite the resubmission of its BLA filing for this indication.

CytoDyn has completed a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than six years.

CytoDyn is also conducting a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at http://www.cytodyn.com.

Forward-Looking StatementsThis press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as "believes," "hopes," "intends," "estimates," "expects," "projects," "plans," "anticipates" and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Company's forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Company's cash position, (ii) the Company's ability to raise additional capital to fund its operations, (iii) the Company's ability to meet its debt obligations, if any, (iv) the Company's ability to enter into partnership or licensing arrangements with third parties, (v) the Company's ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Company's ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Company's clinical trials, (viii) the results of the Company's clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company's products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Company's control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CONTACTSInvestors: Michael MulhollandOffice: 360.980.8524, ext. 102mmulholland@cytodyn.com

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The 11 most mind-blowing, awe-inspiring health discoveries and innovations of 2020 – Business Insider – Business Insider

By daniellenierenberg

MSPhotographic/Getty Images

Most kids with peanut allergies do not outgrow them. But, with a little help, some might be able to better tolerate accidental exposures.

In January, the Food and Drug Administration approved Palforzia, a new drug designed to help kids who are allergic to peanuts react better, if they are accidentally exposed.

"Because there is no cure, allergic individuals must strictly avoid exposure to prevent severe and potentially life-threatening reactions," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research said at the time in a news release. "When used in conjunction with peanut avoidance, Palforzia provides an FDA-approved treatment option to help reduce the risk of these allergic reactions."

Palforzia is not designed to be administered during an allergic reaction, instead it works as an allergy exposure therapy: children ages 4 through 17 receive daily doses of peanut powder under clinical supervision, and slowly up-dose it over time.

In clinical trials, the strategy worked well, but not perfectly. When peanut-allergic kids were fed 600 milligrams of peanut protein, 67.2% of Palforzia recipients who'd been using the medication for six months tolerated it, while only 4% of the control group did.

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Orchard Therapeutics Receives EC Approval for Libmeldy for the Treatment of Early-Onset Metachromatic Leukodystrophy (MLD) – GlobeNewswire

By daniellenierenberg

First gene therapy to receivefull EU marketing authorization for eligible MLD patients

One-time treatment with Libmeldy has been shown to preserve motor and cognitive function

Achievement shared with research alliance partners Fondazione Telethon and Ospedale San Raffaele

BOSTON and LONDON and MILAN, Italy, Dec. 21, 2020 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, and its research alliance partners Fondazione Telethon and Ospedale San Raffaele, today announced that the European Commission (EC) granted full (standard) market authorization for Libmeldy (autologous CD34+ cells encoding the ARSA gene), a lentiviral vector-based gene therapy approved for the treatment of metachromatic leukodystrophy (MLD), characterized by biallelic mutations in theARSAgene leading to a reduction of the ARSA enzymatic activity in children with i) late infantile or early juvenile forms, without clinical manifestations of the disease, or ii) the early juvenile form, with early clinical manifestations of the disease, who still have the ability to walk independently and before the onset of cognitive decline. Libmeldy is the first therapy approved for eligible patients with early-onset MLD.

MLD is a very rare, fatal genetic disorder caused by mutations in the ARSA gene which lead to neurological damage and developmental regression. In its most severe and common forms, young children rapidly lose the ability to walk, talk and interact with the world around them, and most pass away before adolescence. Libmeldy is designed as a one-time therapy that aims to correct the underlying genetic cause of MLD, offering eligible young patients the potential for long-term positive effects on cognitive development and maintenance of motor function at ages at which untreated patients show severe motor and cognitive impairments.

Todays EC approval of Libmeldy opens up tremendous new possibilities for eligible MLD children faced with this devastating disease where previously no approved treatment options existed, said Bobby Gaspar, M.D., Ph.D., chief executive officer of Orchard. Libmeldy is Orchards first product approval as a company, and I am extremely proud of the entire team who helped achieve this milestone. We are grateful for and humbled by the opportunity to bring this remarkable innovation to young eligible patients in the EU.

With Libmeldy, a patients own hematopoietic stem cells (HSCs) are selected, and functional copies of the ARSA gene are inserted into the genome of the HSCs using a self-inactivating (SIN) lentiviral vector before these genetically modified cells are infused back into the patient. The ability of the gene-corrected HSCs to migrate across the blood-brain barrier into the brain, engraft, and express the functional enzyme has the potential to persistently correct the underlying disease with a single treatment.

The EC approval of Libmeldy comes more than a decade after the first patient was treated in clinical trials performed at our Institute, and ushers in a remarkable and long-awaited shift in the treatment landscape for eligible MLD patients, said Luigi Naldini, M.D, Ph.D., director of the San Raffaele-Telethon Institute for Gene Therapy (SR-Tiget) in Milan, Italy. Our team at SR-Tiget has been instrumental in advancing the discovery and early-stage research of this potentially transformative therapy to clinical trials in support of its registration through more than 15 years of studies supported by Fondazione Telethon and Ospedale San Raffaele, and we are extremely proud of this achievement and what it means for patients and the field of HSC gene therapy.

MLD is a heart-breaking disease that causes immeasurable suffering and robs children of the chance of life, said Georgina Morton, chairperson of ArchAngel MLD Trust. As a community, we have been desperate for a treatment for young MLD patients, and we are incredibly excited to now have such a ground-breaking option approved in the EU.

The marketing authorization for Libmeldy is valid in all 27 member states of the EU as well as the UK, Iceland, Liechtenstein and Norway. Orchard is currently undertaking EU launch preparations related to commercial drug manufacturing, treatment site qualification and market access.

Data Supporting the Clinical and Safety Profile of Libmeldy

The marketing authorization for Libmeldy is supported by clinical studies in both pre- and early- symptomatic, early-onset MLD patients performed at the SR-Tiget. Early-onset MLD encompasses the disease variants often referred to as late infantile (LI) and early juvenile (EJ). Clinical efficacy was based on the integrated data analysis from 29 patients with early-onset MLD who were treated with Libmeldy prepared as a fresh (non-cryopreserved) formulation. Results of this analysis indicate that a single-dose intravenous administration of Libmeldy is effective in modifying the disease course of early-onset MLD in most patients.

Clinical safety was evaluated in 35 patients with MLD (the 29 patients from the integrated efficacy analysis as well as six additional patients treated with the cryopreserved formulation of Libmeldy). Safety data indicate that Libmeldy was generally well-tolerated. The most common adverse reaction attributed to treatment with Libmeldy was the occurrence of anti-ARSA antibodies (AAA) reported in five out of 35 patients. Antibody titers in all five patients were generally low and no negative effects were observed in post-treatment ARSA activity in the peripheral blood or bone marrow cellular subpopulations, nor in the ARSA activity within the cerebrospinal fluid. In addition to the risks associated with the gene therapy, treatment with Libmeldy is preceded by other medical interventions, namely bone marrow harvest or peripheral blood mobilization and apheresis, followed by myeloablative conditioning, which carry their own risks. During the clinical studies, the safety profiles of these interventions were consistent with their known safety and tolerability.

For further details, please see the Summary of Product Characteristics (SmPC).

About MLD and Libmeldy

MLD is a rare and life-threatening inherited disease of the bodys metabolic system occurring in approximately one in every 100,000 live births. MLD is caused by a mutation in the arylsulfatase-A (ARSA) gene that results in the accumulation of sulfatides in the brain and other areas of the body, including the liver, gallbladder, kidneys, and/or spleen. Over time, the nervous system is damaged, leading to neurological problems such as motor, behavioral and cognitive regression, severe spasticity and seizures. Patients with MLD gradually lose the ability to move, talk, swallow, eat and see. In its late infantile form, mortality at five years from onset is estimated at 50% and 44% at 10 years for juvenile patients.1

Libmeldy (autologous CD34+ cell enriched population that contains hematopoietic stem and progenitor cells (HSPC) transduced ex vivo using a lentiviral vector encoding the human arylsulfatase-A (ARSA) gene), also known as OTL-200, is approved in the European Union for the treatment of MLD in eligible early-onset patients. In the U.S., OTL-200 is an investigational therapy which has not been approved by the U.S. Food and Drug Administration (FDA) for any use. Libmeldy was acquired from GSK in April 2018 and originated from a pioneering collaboration between GSK and the Hospital San Raffaele and Fondazione Telethon, acting through their joint San Raffaele-Telethon Institute for Gene Therapy in Milan, initiated in 2010.

About Orchard

Orchard Therapeutics is a global gene therapy leader dedicated to transforming the lives of people affected by rare diseases through the development of innovative, potentially curative gene therapies. Our ex vivo autologous gene therapy approach harnesses the power of genetically modified blood stem cells and seeks to correct the underlying cause of disease in a single administration. In 2018, Orchard acquired GSKs rare disease gene therapy portfolio, which originated from a pioneering collaboration between GSK and the San Raffaele Telethon Institute for Gene Therapy in Milan, Italy. Orchard now has one of the deepest and most advanced gene therapy product candidate pipelines in the industry spanning multiple therapeutic areas where the disease burden on children, families and caregivers is immense and current treatment options are limited or do not exist.

Orchard has its global headquarters inLondonandU.S.headquarters inBoston. For more information, please visitwww.orchard-tx.com, and follow us on Twitter and LinkedIn.

Availability of Other Information About Orchard

Investors and others should note that Orchard communicates with its investors and the public using the company website (www.orchard-tx.com), the investor relations website (ir.orchard-tx.com), and on social media (Twitter andLinkedIn), including but not limited to investor presentations and investor fact sheets,U.S. Securities and Exchange Commissionfilings, press releases, public conference calls and webcasts. The information that Orchard posts on these channels and websites could be deemed to be material information. As a result, Orchard encourages investors, the media, and others interested in Orchard to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Orchards investor relations website and may include additional social media channels. The contents of Orchards website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

About Fondazione Telethon, Ospedale San Raffaele and the San Raffaele-Telethon Institute for Gene Therapy (SR-Tiget)

Based in Milan, Italy, the San Raffaele-Telethon Institute for Gene Therapy (SR-Tiget) is a joint venture between the Ospedale San Raffaele, a clinical-research-university hospital established in 1971 to provide international-level specialized care for the most complex and difficult health conditions, and Fondazione Telethon, an Italian biomedical charity born in 1990 and focused on rare genetic diseases. SR-Tiget was established in 1995 to perform research on gene transfer and cell transplantation and translate its results into clinical applications of gene and cell therapies for different genetic diseases. Over the years, the Institute hasgiven a pioneering contribution to the field with relevant discoveries in vector design, gene transfer strategies, stem cell biology, identity and mechanism of action of innate immune cells. SR-Tiget has also established the resources and framework for translating these advances into novel experimental therapies and has implemented several successful gene therapy clinical trials for inherited immunodeficiencies, blood and storage disorders, which have already treated >115 patients and have led through collaboration with industrial partners to the filing and approval of novel advanced gene therapy medicines.

For more information:

Forward-Looking Statements

This press release contains certain forward-looking statements about Orchards strategy, future plans and prospects, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may be identified by words such as anticipates, believes, expects, plans, intends, projects, and future or similar expressions that are intended to identify forward-looking statements. Forward-looking statements include express or implied statements relating to, among other things, Orchards business strategy and goals, including its plans and expectations for the commercialization of Libmeldy, and the therapeutic potential of Libmeldy, including the potential implications of clinical data for eligible patients. These statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, many of which are beyond Orchards control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. In particular, these risks and uncertainties include, without limitation:: the risk that prior results, such as signals of safety, activity or durability of effect, observed from clinical trials of Libmeldy will not continue or be repeated in our ongoing or planned clinical trials of Libmeldy, will be insufficient to support regulatory submissions or marketing approval in the US or to maintain marketing approval in the EU, or that long-term adverse safety findings may be discovered; the inability or risk of delays in Orchards ability to commercialize Libmeldy, including the risk that we may not secure adequate pricing or reimbursement to support continued development or commercialization of Libmeldy; the risk that the market opportunity for Libmeldy, or any of Orchards product candidates, may be lower than estimated; and the severity of the impact of the COVID-19 pandemic on Orchards business, including on clinical development, its supply chain and commercial programs. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements.

Other risks and uncertainties faced by Orchard include those identified under the heading "Risk Factors" in Orchards quarterly report on Form 10-Q for the quarter endedSeptember 30, 2020, as filed with theU.S. Securities and Exchange Commission(SEC), as well as subsequent filings and reports filed with theSEC. The forward-looking statements contained in this press release reflect Orchards views as of the date hereof, and Orchard does not assume and specifically disclaims any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

Contacts

InvestorsRenee LeckDirector, Investor Relations+1 862-242-0764Renee.Leck@orchard-tx.com

MediaChristine HarrisonVice President, Corporate Affairs+1 202-415-0137media@orchard-tx.com

1 Mahmood et al. Metachromatic Leukodystrophy: A Case of Triplets with the Late Infantile Variant and a Systematic Review of the Literature.Journal of Child Neurology2010, DOI:http://doi.org/10.1177/0883073809341669

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Orchard Therapeutics Receives EC Approval for Libmeldy for the Treatment of Early-Onset Metachromatic Leukodystrophy (MLD) - GlobeNewswire

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Outlook on the Biopreservation Global Market to 2026 – Profiling Avantor, BioLife Solutions and ThermoGenesis Among Others – GlobeNewswire

By daniellenierenberg

Dublin, Dec. 21, 2020 (GLOBE NEWSWIRE) -- The "Biopreservation Market by Type, Application, End-user, and Geography - Global Forecast to 2026" report has been added to ResearchAndMarkets.com's offering.

Biopreservation is a process that assists in the conservation of biospecimens such as DNA, saliva, and plasma. This process of biopreservation generally increases the durability, shelf life, and purity of the biosamples. The types of equipment in this process include freezers, liquid nitrogen, consumables, and also media & laboratory information management systems.

This process is also used to preserve food and extend its shelf life, specifically by using lactic acid bacteria. Growth in healthcare spending is assumed for better access to quality healthcare and advanced technology products such as biopreservation facilities, thereby widening the growth expectations. Moreover, the bio-banks, hospitals, and gene banks, which are major end-users for this market, are stimulating the key providers to establish technologically advanced biopreservation products to improve patient outcomes. The Biopreservation Market is projected to grow at a rate of 9.2% CAGR by 2026.

The biopreservation market has been analyzed by utilizing the optimum combination of secondary sources and in-house methodology, along with an irreplaceable blend of primary insights. The real-time assessment of the market is an integral part of our market sizing and forecasting methodology. Our industry experts and panel of primary participants have helped in compiling relevant aspects with realistic parametric estimations for a comprehensive study. The participation share of different categories of primary participants is given below:

In the market for biopreservation, the application of biopreservation consists of therapeutic applications, research applications, clinical trials, and other applications. The biopreservation is primarily applied in therapeutics due to the advancements in regenerative medicine & customized medicine, an increase in the shift of cord blood banking, and the rising incidence of chronic diseases.

The end-users of the biopreservation market include biobanks, gene banks, hospitals, and other end users. The biobanks segment is expected to have a major share in the market. The major share of this segment is attributed to the increasing preference for the preservation of stem cells and the rising numbers of sperm and egg banks.

Further, according to the regional market of biopreservation, the North American region is recorded for the colossal share in the market. This is due to the continuous drug developments and the arrival of advanced therapies in the domain of biomedical research. Additionally, the increasing requirement of expensive and improved treatment for patients' chronic diseases is the key factor.

The rising incidence of chronic diseases, including cardiac, renal diseases, diabetes, and obesity, is the crucial factor that will propel the biopreservation market growth in the prevailing period. Government initiatives to encourage stem cell therapies to treat the disease, which will again propel market growth. Conversely, the strict regulations for producing biopreservation products and the evolution of room temperature storage procedures may limit the biopreservation market growth.

Merck KGaA, Avantor, Inc., Bio-Techne Corporation, BioLife Solutions, Inc., Thermo Fisher Scientific Inc, ThermoGenesis Holdings, Inc., Worthington Industries, Inc., Chart Industries, Inc, So-Low Environmental Equipment Co., Inc., Princeton BioCision, LLC, Shanghai Genext Medical Technology Co. Ltd, Exact Sciences Corporation, Helmer Scientific, Inc., CryoTech, Inc., Arctiko, Nippon Genetics Europe, PHC Holdings Corporation, STEMCELL Technologies, Inc., AMS Biotechnology, and OPS Diagnostics. These are the few companies list of the biopreservation market.

Since the rapid increase in the number of research and developments gives the way of potentials for market growth, the biopreservation of biological samples has become a crucial segment. This helps the researchers to access the data of the number of people by the preserved biological samples.

This research presents a thorough analysis of market share, the present trends, and forthcoming evaluations to explain the approaching investment pockets.

This research provides market insights from 2020 to 2026, which is predicted to allow the shareholders to capitalize on the forthcoming opportunities.

This report further offers comprehensive insights into the region, which helps to understand the geographical market and assist in strategic business planning and ascertain future opportunities.

Key Topics Covered:

1. Executive Summary

2. Industry Outlook2.1. Industry Overview2.2. Industry Trends

3. Market Snapshot3.1. Market Definition3.2. Market Outlook3.2.1. PEST Analysis3.2.2. Porter Five Forces3.3. Related Markets

4. Market characteristics4.1. Market Evolution4.2. Market Trends and Impact4.3. Advantages/Disadvantages of Market4.4. Regulatory Impact4.5. Market Offerings4.6. Market Segmentation4.7. Market Dynamics4.7.1. Drivers4.7.2. Restraints4.7.3. Opportunities4.8. DRO - Impact Analysis

5. Type: Market Size & Analysis5.1. Overview5.2. Biopreservation Media5.2.1. Nutrient Media5.2.2. Sera5.2.3. Growth Factors & Supplements5.3. Biospecimen Equipment5.3.1. Temperature Control Systems5.4. Freezers5.5. Cryogenic Storage Systems5.6. Thawing Equipment5.7. Refrigerators5.7.1. Accessories5.7.2. Alarms & Monitoring systems5.7.3. Incubators5.7.4. Centrifuges5.7.5. Other Equipment

6. Application: Market Size & Analysis6.1. Overview6.2. Therapeutic Applications6.3. Research Applications6.4. Clinical Trials6.5. Other Applications

7. End User: Market Size & Analysis7.1. Overview7.2. Biobanks7.3. Gene Banks7.4. Hospitals7.5. Other End Users

8. Geography: Market Size & Analysis8.1. Overview8.2. North America8.3. Europe8.4. Asia Pacific8.5. Rest of the World

9. Competitive Landscape9.1. Competitor Comparison Analysis9.2. Market Developments9.2.1. Mergers and Acquisitions, Legal, Awards, Partnerships9.2.2. Product Launches and execution

10. Vendor Profiles10.1. Merck KGaA10.1.1. Overview10.1.2. Financials10.1.3. Products & Services10.1.4. Recent Developments10.1.5. Business Strategy10.2. Avantor, Inc10.2.1. Overview10.2.2. Financials10.2.3. Products & Services10.2.4. Recent Developments10.2.5. Business Strategy10.3. Bio-Techne Corporation10.3.1. Overview10.3.2. Financials10.3.3. Products & Services10.3.4. Recent Developments10.3.5. Business Strategy10.4. BioLife Solutions, Inc10.4.1. Overview10.4.2. Financials10.4.3. Products & Services10.4.4. Recent Developments10.4.5. Business Strategy10.5. Thermo Fisher Scientific Inc10.5.1. Overview10.5.2. Financials10.5.3. Products & Services10.5.4. Recent Developments10.5.5. Business Strategy10.6. ThermoGenesis Holdings, Inc10.6.1. Overview10.6.2. Financials10.6.3. Products & Services10.6.4. Recent Developments10.6.5. Business Strategy10.7. Worthington Industries, Inc10.7.1. Overview10.7.2. Financials10.7.3. Products & Services10.7.4. Recent Developments10.7.5. Business Strategy10.8. Chart Industries, Inc10.8.1. Overview10.8.2. Financials10.8.3. Products & Services10.8.4. Recent Developments10.8.5. Business Strategy10.9. So-Low Environmental Equipment Co.,Inc10.9.1. Overview10.9.2. Financials10.9.3. Products & Services10.9.4. Recent Developments10.9.5. Business Strategy10.10. Princeton BioCision, LLC10.10.1. Overview10.10.2. Financials10.10.3. Products & Services10.10.4. Recent Developments10.10.5. Business Strategy

11. Companies to Watch11.1. Shanghai Genext Medical Technology Co. Ltd11.1.1. Overview11.1.2. Products & Services11.1.3. Business Strategy11.2. Exact Sciences Corporation11.2.1. Overview11.2.2. Products & Services11.2.3. Business Strategy11.3. Helmer Scientific, Inc11.3.1. Overview11.3.2. Products & Services11.3.3. Business Strategy11.4. CryoTech, Inc11.4.1. Overview11.4.2. Products & Services11.4.3. Business Strategy11.5. Arctiko11.5.1. Overview11.5.2. Products & Services11.5.3. Business Strategy11.6. Nippon Genetics Europe11.6.1. Overview11.6.2. Products & Services11.6.3. Business Strategy11.7. PHC Holdings Corporation11.7.1. Overview11.7.2. Products & Services11.7.3. Business Strategy11.8. STEMCELL Technologies, Inc11.8.1. Overview11.8.2. Products & Services11.8.3. Business Strategy11.9. AMS Biotechnology11.9.1. Overview11.9.2. Products & Services11.9.3. Business Strategy11.10. OPS Diagnostics11.10.1. Overview11.10.2. Products & Services11.10.3. Business Strategy

12. Analyst Opinion

13. Annexure13.1. Report Scope13.2. Market Definitions13.3. Research Methodology13.3.1. Data Collation and In-house Estimation13.3.2. Market Triangulation13.3.3. Forecasting13.4. Report Assumptions13.5. Declarations13.6. Stakeholders13.7. Abbreviations

For more information about this report visit https://www.researchandmarkets.com/r/pl06wm

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Outlook on the Biopreservation Global Market to 2026 - Profiling Avantor, BioLife Solutions and ThermoGenesis Among Others - GlobeNewswire

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Scientists have restored youth to aging eyes in mice – Massive Science

By daniellenierenberg

Following the harassment of Christian Cooper in Central Park in May 2020, Black birders created #BlackBirdersWeek to celebrate Black nature enthusiasts and highlight their belonging in outdoor spaces. Since then, dozens of campaigns have emerged to amplify and appreciate Black academics, scientists, and naturalists.

Next up is #BlackInMarineScienceWeek, running from November 29th to December 5th.Led by founder Dr. Tiara Moore and organizers Amani Webber-Schultz, Dr. Camille Gaynus, Carlee Jackson, Al Troutman, Jasmin Graham, Jeanette Davis, Kris Howard, Leslie Townsell, Kaylee Arnold, and Jaida Elcock, this week represents an opportunity for community building and improved representation.

There are few Black folks in ecology and even fewer in marine ecology, says Arnold, a science communicator and disease ecologist. The network that Ive gained through organizing this week is phenomenal. Meeting other Black marine scientists and showing that to the world, especially young Black folks, is a way to say we exist, were here. We have a full day dedicated to young kids, which is unique and exciting.

The organizers hope that the week will help normalize Black folks doing marine research, inspire younger generations, and remind everyone to check their preconceived notions.

"When I say I study sharks people seem concerned about my swimming or my hair, [and] sometimes respond with 'Oh, thats super interesting'... I dont know if that's because it's unusual for people to study sharks or because Im Black and I study sharks, recalls Elcock, an elasmobranch movement ecologist, science communicator, and co-founder of Minorities in Shark Science. Science is for everybody. People say there isn't diversity because [Black] people arent interested... thats clearly not true theres a whole week dedicated [to it]."

Discussion this week will address the fact that exclusion, not lack of interest, led to todays lack of representation. Centuries of segregation and underinvestment in Black neighborhood pools led to, and are perpetuated by, these incorrect and harmful ideas.

My grandparents and my mom said there were just no pools for her to go to... I had a very different experience. Despite people trying to push us out of the water and science, we persevered, and now we get to break down those stereotypes, notes Arnold.

Black in Marine Science Week is here to do just that, showcasing organizers and participants from every imaginable marine science niche, all shaping how society views the oceans and its inhabitants.

There's more Black folks than even we know and are showcasing. I hope that if the media picks up on the number of us as well, and has better representation. Seminar series are extremely white, and now you have a resource of people you can invite instead, emphasizes Arnold, pointing to the necessity of non-Black marine scientists to step up and ensure representation continues beyond this joyous and educational week.

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The Adrenomyeloneuropathy Treatment Market to grow on an emphatic note from 2019 to 2029 – PharmiWeb.com

By daniellenierenberg

Adrenomyeloneuropathy is a rare genetic neuro-degenerative disease. Adrenomyeloneuropathy is the adult onset of adrenoleukodystrophy caused by the mutation in ABCD1 gene occurs usually in young boys. Adrenomyeloneuropathy disease affect the nerve cells in the spine and brain and the adrenal glands. Adrenomyeloneuropathy symptoms includes stiffness, weakness and pain in the legs. Adrenomyeloneuropathy is also known as progressive spastic paraparesis. Damage to the nerves of the legs which causes unsteadiness and fall, also the bladder, bowel and sexual organs are affected by the adrenomyeloneuropathy. Rare diseases affect vast numbers of people, with current data representing 30 million sufferers in the EU alone and 30 million affected in the US. There is no cure to Adrenomyeloneuropathy. However some treatment might stop the progression of Adrenomyeloneuropathy such as stem cell transplants. Blood testing, MRI test, vision screening and Skin biopsy and fibroblast cell culture are done for the diagnosis for the adrenomyeloneuropathy. Continued advances in the treatment of adrenomyeloneuropathy will further propel the adrenomyeloneuropathy treatment market.

Growing cases of rare disease and development of new and advanced treatment for rare disease is expected to boost the adrenomyeloneuropathy treatment market. Growing preference for healthy lifestyle and favorable government regulation spur the Adrenomyeloneuropathy treatment market in the forecast period. Development of new technology and devices for the diagnosis of genetic disorders will propel the adrenomyeloneuropathy treatment market. Rising focus on the research and development of new therapeutic and drug treatment and growing government funding for the orphan drug is expected to drive the adrenomyeloneuropathy treatment market.

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However, stringent regulations for the drug development and high cost of associated with the treatment is expected to hinder the adrenomyeloneuropathy treatment market.

The global adrenomyeloneuropathy treatment market is segmented on basis of disease type, drug type and end user and geography.

Development of novel drugs and undergoing clinical trial for the rare disease is expected to boost adrenomyeloneuropathy treatment market. More than 3,000 drugs are in active development for one of the rare disease. Progress in genomics and biomedical science for the development of rare disease drug is expected to spur the adrenomyeloneuropathy treatment market. Various pharmaceutical companies are focusing on developing drug for the low prevalence disease types and rising funding and collaboration among the key players and government is expected to spur the adrenomyeloneuropathy treatment market.

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The North America market for adrenomyeloneuropathy treatment is expected to retain its dominance, owing to increasing patient pool for rare disease, increasing government funding to accelerate the research and development for rare disease. According to Genetic and Rare Diseases Information Center, more than 25 million Americans are suffering from rare disease in United States.Europe is expected to account for the second largest share in the global adrenomyeloneuropathy treatment market owing to growing clinical trial funding programs for orphan drug development and high prevalence of adrenomyeloneuropathy and high treatment seeking rate. Asia Pacific is expected to show significant growth, owing to increasing diagnosis rate and improvement in healthcare infrastructure. China is expected to show significant growth in the adrenomyeloneuropathy treatment market, due to rising population improving R&D capability, increasing per capita heath spending. Latin America and Middle East & Africa is expected to show growth owing to lack of diagnosis and inadequate healthcare facilities and lack of skilled physicians for Adrenomyeloneuropathy Treatment market.

Examples of some of the key manufacturer present in the global adrenomyeloneuropathy treatment market are Ascend Biopharmaceuticals, Novadip Biosciences, Eureka Therapeutics, Human Longevity, Regeneus, Allogene Therapeutics, BioRestorative Therapies, Immatics Biotechnologies, NewLink Genetics, Cytori Therapeutics, Talaris Therapeutics among others.

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At 14.6% CAGR, Cell Banking Outsourcing Market 2020 Industry Analysis of Current Trends and Opportun – PharmiWeb.com

By daniellenierenberg

Pune, Maharashtra, India, December 18 2020 (Wiredrelease) Brandessence Market Research and Consulting Pvt ltd :Global Cell Banking Outsourcing Market is valued at USD 7122.6 Million in 2019 and expected to reach USD 18489.6 Million by 2026 with the CAGR of 14.6% over the forecast period.

Rising prevalence of cancer and infectious chronic disorders couples with growing demand for research and development in therapy viral cell banking and viral cell banking safety testing are expected to propel the growth of the Global Cell Banking Outsourcing Market.

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Scope of Global Cell Banking Outsourcing Market Report

The cell banking outsourcing is an ability that stores cells of specific genome for the purpose of future use in a product or medicinal needs to use of gene therapy, stem cell therapy, biopharmaceutical production that target on novel active sites. They are frequently containing expansive amounts of base cell material that can be utilized for various projects. The cell banking outsourcing can be used to generate detailed characterizations of cell lines and can also help mitigate cross-contamination of a cell line. Hence, the cell banking outsourcing is commonly used within fields including stem cell research and pharmaceuticals with cryopreservation being the traditional method of keeping cellular material intact. However, the cell banking is most generally used in stem cell research and therapy. The similar types of cell banking include master cell banks and working cell banks. Although, the master cell banks are expanded to form working cell banks consist of pure cells from are replicated whereas working cell banks consist of thawed cells that are replicated in cell culture.

Additionally, it is a process of replicating and storing cells for the purpose of future use. This storage of these cell samples can be utilized for research purposes and for surgical reconstruction of damaged body structures. However, the bank storage in cell banking encompasses preservation of both master and working cell banking, and their respective safety testing. The cell banking outsourcing expected to witness lucrative growth over the forecast period owing to the presence of increased research in cell line development coupled with the presence of market players providing outsourcing services for cell banking and cell line storage to different hospitals and clinical research organizations.

Global Cell Banking Outsourcing Market report is segmented on the basis of type, application, and by regional & country level. Based on type, global cell banking outsourcing market is classified as the master cell banking, viral cell banking and working cell banking. Based upon application, global cell banking outsourcing is classified into bank storage, working cell bank storage, master cell bank storage cell storage stability testing, bank preparation, bank characterization & testing and others.

The regions covered in this cell banking outsourcing market report are North America, Europe, Asia-Pacific and Rest of the World. On the basis of country level, market of cell banking outsourcing is sub divided into U.S., Mexico, Canada, U.K., France, Germany, Italy, China, Japan, India, South East Asia, GCC, Africa, etc.

Cell Banking Outsourcing Manufacturers:

Some major key players for Global Cell Banking Outsourcing Market are,

BioReliance Covance Global Stem Inc BSL Disservice Clean cells Charles River Laboratories Lonza Toxikon Corporation Cryobanks International India Wuxi Apptec Reliance Life Sciences Life Cell International Pvt. Ltd BioOutsource (Sartorious) CordLife PXTherapeutics SA SGS Life Sciences Texcell Cryo-Cell International Inc. Others

Global Cell Banking Outsourcing Market Dynamics

The rapidly increasing awareness for stem cell banking in the developing countries, and increasing governments initiatives that promote awareness for stem cell isolation and related benefits are some of the major factors driving the market growth during the forecast period. In addition, increasing application of stem cells for developing personalized medicines to minimize the spread of various chronic diseases and also the association of aging with the inability of the body to maintain tissue turnover and hemostasis has helped researchers to focus on this target population for providing relative therapies that would act effectively on the damaged cells. These factors are also supplementing the market growth. According to the World Health Organization (WHO), estimates of cancer incidence and mortality produced by the International Agency for Research on Cancer, with a focus on geographic variability across 20 globes about 18.1 million new cancer cases about 17.0 million excluding no melanoma skin cancer and 9.6 million cancer deaths in 2018. Furthermore, the master cell banks are useful for the preparation of working cell banks and thus find applicability in various research and development perspectives for stem cell therapy and gene therapy thereby resulting to section growth. The occurrence of favorable government initiatives pertaining to the R&D for development of stable cell lines, the opening of new technology for storage and description of cell lines are among the critical factors predictable to advance market growth over the forecast period.

However, the high cost associated with storing these cells in cell banks is a major challenge faced by this market which may hamper the growth of cell banking outsourcing market. In addition, the various legal challenges associate with banking a variety of cells, especially considering stem cells banking, are expected to restrain market growth. The advanced technologically cryopreservation techniques are expected to fuel the growth of this market throughout the forecast period. In spite of that, the increase in the average life expectations due to advanced medical research and improved general lifestyle of the population and straightforward regulations for the stem cell researchers are expected to create significant potential for this market in coming few years. Increasing number of adipose tissue banking can offer various opportunities of the cell banking outsourcing market.

Global Cell Banking Outsourcing Market Regional Analysis

North America is expected to dominate the global cell banking outsourcing drug market due to the highest market share owing to the increasing number biopharmaceutical companies & manufacturers and increasing awareness for the use of stem cells as therapeutic proteins and antibiotics in this region. According to the World Health Organization (WHO), the American Cancer Society epidemiologists, at least 42% of newly diagnosed cancers in the U.S. about 729,000 cases are potentially avoidable, including 19% that are caused by smoking and 18% that are caused by a combination of excess body weight, physical inactivity, excess alcohol consumption, and poor nutrition. In addition, presence of regulatory authorities that promotes continuous R&D activities is also supplementing the market growth in North America.

The Asia Pacific is expected to witness significant growth in demand over the forecast period owing to increase in number of supportive government initiatives pertaining to investments in biotechnology sector in this region. In addition, the ongoing R&D activities for cancer treatment and fertility preservation facilitate the demand for cell banking services in this region.

Key Benefits for Global Cell Banking Outsourcing Market Report

Global Cell Banking Outsourcing Market report covers in depth historical and forecast analysis.

Global Cell Banking Outsourcing Market research report provides detail information about Market Introduction, Market Summary, Global market Revenue (Revenue USD), Market Drivers, Market Restraints, Market opportunities, Competitive Analysis, Regional and Country Level.

Global Cell Banking Outsourcing Market report helps to identify opportunities in market place.

Global Cell Banking Outsourcing Market report covers extensive analysis of emerging trends and competitive landscape.

Global Cell Banking Outsourcing Market Segmentation:

By Type:Master Cell Banking, Viral Cell Banking, Working Cell Banking

By Application:Bank Storage, Working Cell Bank Storage, Master Cell Bank Storage, Cell Storage Stability Testing, Bank Preparation, Bank Characterization & Testing

Regional & Country AnalysisNorth America, U.S., Mexico, Canada , Europe, UK, France, Germany, Italy , Asia Pacific, China, Japan, India, Southeast Asia, South America, Brazil, Argentina, Columbia, The Middle East and Africa, GCC, Africa, Rest of Middle East and Africa

Table of Content

1. Chapter Report Methodology1.1. Research Process1.2. Primary Research1.3. Secondary Research1.4. Market Size Estimates1.5. Data Triangulation1.6. Forecast Model1.7. USPs of Report1.8. Report Description

2. Chapter Global Cell Banking Outsourcing Market Overview: Qualitative Analysis2.1. Market Introduction2.2. Executive Summary2.3. Global Cell Banking Outsourcing Market Classification2.4. Market Drivers2.5. Market Restraints2.6. Market Opportunity2.7. Cell Banking Outsourcing Market: Trends2.8. Porters Five Forces Analysis2.9. Market Attractiveness Analysis

3. Chapter Global Cell Banking Outsourcing Market Overview: Quantitative Analysis

4. Chapter Global Cell Banking Outsourcing Market Analysis: Segmentation By Type

5. Chapter Global Cell Banking Outsourcing Market Analysis: Segmentation By Application

Continued.

Complete Report Details @ https://brandessenceresearch.com/healthcare/cell-banking-outsourcing-market-size

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At 14.6% CAGR, Cell Banking Outsourcing Market 2020 Industry Analysis of Current Trends and Opportun - PharmiWeb.com

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The Definitive Guide to All Things Vegan By Drunk Elephant – LIVEKINDLY

By daniellenierenberg

Launched in 2013, cruelty-free skincare brand Drunk Elephant has captured the attention of beauty experts, brands, and a strong customer following.

The company, founded by former stay-at-home mom Tiffany Masterson, is one of the fastest-growing skin care brands in the industry. According to Fashionista, this is largely thanks to its philosophy. Masterson is a believer in clean beauty, an ethos thats reflected in Drunk Elephants product line-up. Speaking to how the company came to be, Masterson said, I came up with these criteria: It has to be nontoxic or low-hazard and it has to be bioavailable, meaning able to get into your skin.

As such, all Drunk Elephant products are formulated without what Masterson deemed the Suspicious Six, ingredients that she believed her company could do without: essential oils, silicones, sodium lauryl sulfate aka SLS, drying alcohols, silicones, chemical screens, and fragrances and dyes. When it comes to ingredients, Drunk Elephant goes by the philosophy of If theres any DOUBT, its OUT.

I determined that the six ingredients I wanted to avoid, which I realized were largely there [in competitors products] for marketing, Masterson explained. Silicones make a product feel better; dyes make a product look better; essential oils and fragrance make a product smell better; SLS is a cleansing agent that penetrates your skin and irritates and strips it.

She wanted her brand to be as clean and non-irritating as possible. She even helped formulate the products herself: We went through, ingredient by ingredient, and we swapped out a couple that canceled each other out or that did the same thing, but the resulting ingredient decks were very similar to the ones I first wrote down for every product.

For Masterson, it was a perfect storm of her desire to make a clean beauty brand and evolving consumer shopping habits. Consumer mistrust in companies is on the rise, but for good reason. Last July, Johnson & Johnson was told to pay $4.7 billion to families who claimed that using its talcum powder products caused their ovarian cancer.

While natural and clean beauty are on the rise, Vox points out that the terms are not regulated by the FDA nor the Federal Trade Commission. This means that any company can use the terms for their products and define it as they wish. Clean beauty is still finding favor with consumers its a trend thats been highlighted by Whole Foods Market. People are also becoming concerned over animal ingredients in skincare and makeup, which has helped lead to the rise of vegan beauty, according to The New York Times.

But Drunk Elephants ingredients list shows that Masterson takes her all-natural ethos seriously. In addition to being clean, all products are made in the US.

The company has also resonated with customers Masterson hasnt done any traditional marketing or influencer partnerships. But, she was able to build her brand to the point where she landed in Sephora the TLC Sukari Babyfacial was actually one of the stores top-selling products of 2017.

Drunk Elephant is a cruelty-free brand, but not all products are vegan. The company uses honey in certain formulas. However, it currently offers 12 products formulated without any animal ingredients.

Drunk Elephants A-Passioni Retinol Cream combines vegan retinol with skin-nourishing ingredients like peptides, vitamin F, and plant-based ingredients like passionfruit, apricot, marula and jojoba oils, and kale. This vegan face cream was formulated to diminish the appearance of fine lines and wrinkles and sun damage while evening your skin tone and texture for a younger-looking complexion. Its free from essential oils, silicones, and fragrance.

Check it out here.

Drunk Elephants C-Tango Multivitamin Eye Cream was specially formulated for the sensitive skin around your eyes. This rich, cruelty-free cream features eight peptides, five different kinds of vitamin C and cucumber extract that are said to make skin stronger. According to the company, its rich in antioxidants, ceramides and plant oils that restore and refresh appearance. It can be used in the morning or at night. This cruelty-free formula was named editors choice by Womens Health magazine.

Check it out here.

Described as a retro-style moisturizer, the Lala Retro Whipped Cream is formulated for dull, dry skin. The cream, which has a light, airy texture, is formulated with six African oils that help keep moisture locked in. It contains plantain extract to brighten and sodium hyaluronate crosspolymer that hydrates all day long. Like other Drunk Elephant products, it contains antioxidant-rich ingredients like green tea, which soothes the skin and fights signs of aging. Although its rich, the light airy texture keeps it from feeling heavy on the skin, plus it has a skin friendly pH level of 5.5.

This cream is also a three-time consecutive winner of Allures Readers Choice Awards as well as the 2017 winner of InStyle magazines Readers Choice Beauty Awards.

Check it out here.

Drunk Elephant calls the B-Hydra Intensive Hydration Gel a cool glass of water for your thirsty skin.With a light texture, this gel moisturizer was designed to brighten skintone and improve texture with provitamin B and pineapple ceramide, which helps your skin retain moisture. A blend of watermelon rind, apple, and lentil is said to provide hydration for up to 24 hours. It was designed with molecular size and pH level in mind, resulting in a bio-available moisturizer that keeps your skin looking healthy without irritating it.

Check it out here.

With a breakthrough formula, Protini Polypeptide Cream contains a proprietary lend of peptides, amino acids, and pygmy waterlily that improves skin tone, texture, and firmness. According to Drunk Elephant, the protein-rich formula reduces the appearance of fine lines, wrinkles, and sun damage they say its like adding a shot of plant-based protein to your smoothie. Its ideal for all skin types.

This cruelty-free and vegan moisturizer also won the 2018 Healthy Skin Award from Womens Health and the 2018 Skin Award from Cosmopolitan.

Check it out here.

The Shaba Complex Eye Serum is a satiny moisturizer made to tackle fine lines, wrinkles, and sun damage in the skins delicate undereye area. With ingredients like black tea ferment and copper peptides, this vegan eye serum helps smooth skin and is said to slow down the signs of aging. It also contains edelweiss stem cells and niacinamide, which work to reduce wrinkles. The antioxidant-rich ingredient Co-Q10 helps prevent premature signs of aging and fades age spots.

Check it out here.

The Beste No 9 Jelly Cleanser gets your skin clean without harsh ingredients. A blend of surfactants and emollients gets rid of makeup, excess oil, dirt, and pollution and leaves skin feeling soft when rinsed away. Free from SLS and essential oils, its ideal for all skin types, including sensitive.

This cruelty-free and vegan jelly cleanser was a winner of the 2018 Total Beauty Awards, the 2018 Cosmopolitan Skin Awards, and the 2018 Self Healthy Beauty Awards.

Check it out here.

The three-in-one Juju Bar cleanses, exfoliates, and moisturizes your skin without harsh ingredients. This mild vegan soap bar is formulated with thermal mud and bamboo powder, which help create a lather that helps get rid of dirt and oil. Its also said to minimize the appearance of your pores A superfood blend of acai and goji extracts also help fight the signs of aging while marula oil provides moisture. Its also fragrance-free and wont dry your skin out like conventional bar skin.

Check it out here.

The D-Bronzi Anti-Pollution Sunshine Serum delivers a bronzed look without the long-term consequences of sun damage. This vegan bronzer is made with a chronopeptide that is said to mimic the antioxidant effects of vitamin D, marula oil, and black currant seeds while vitamin F moisturizes and protects. Antioxidant-rich ingredients like raw cocoa powder and white tea also help protect your skin against environmental stressors like pollution while giving your skin a sun-kissed glow.

According to Drunk Elephant, a little bit goes a long way, so it should be mixed with a serum or moisturizer. Its free from fragrance, essential oil, and silicones.

Check it out here.

The T.L.C. Framboos Glycolic Night Serum is a 12 percent AHA/BHA moisturizer that helps refine and resurface skin for a more radiant complexion while reducing the appearance of fine lines, wrinkles, and discoloration. Its said to help boost the performance of other products. This cruelty-free serum is formulated with a blend of glycolic, lactic, tartaric, citric, and salicylic acids plus raspberry extract to deliver chemical exfoliation without harshness. It also contains horse chestnut and white tea to sooth the skin. While AHAs can be sensitizing, plant extracts help keep it balanced.

This vegan and cruelty-free night serum was a winner of the 2018 Shape Editor Pick, the 2018 Real Simple Road Test, and was the product winner of New Beautys Beauty Choice Awards.

Check it out here.

The T.L.C. Sukari Babyfacial is an AHA/BHA, cruelty-free and vegan facial in a bottle. Formulated with every skin type in mind, its made from a blend of glycolic, tartaric, lactic, citric, and salicylic acids that gently exfoliate. Antioxidants like matcha, apple, and milk thistle sooth while sodium hyaluronate crosspolymer and plant-based oils hydrate and nourish. It also contains chickpea flour, which brightens and balances. Niacinamide aka vitamin B3 fights the signs of aging and passion fruit seed oil combats redness. This hydrating facial is said to brighten and tone while minimizing the appearance of pores and fine lines and leaving your skin feeling baby-soft.

A customer favorite, this was a winner of the 2018 Essence Black Beauty Awards, the 2019 Teen Vogue Acne Awards, was featured in Glamour, and it was named on the Into the Gloss Top 25 list.

Check it out here.

Drunk Elephants Virgin Marula Luxury Facial Oil is a luxury moisturizer made from the antioxidants tocopherol (vitamin E), tocotrienol, phenolic compounds, and flavonoids, plus omegas 6 and 9. Described as being like rehab for your skin,this facial oil nourishes your skin to provide a youthful glow. The virgin marula oil featured is extracted from the pip of the fruit and is left pure, without fragrance or added ingredients. This quick-absorbing oil helps reverse the skins of aging, redness, and blotchiness while improving elasticity. Its also naturally anti-microbial and ideal for all skin types.

According to Drunk Elephant, its Virgin Marula Luxury Facial oil is cold-pressed using unheated water extraction, which ensures that the oil stays fresher longer. Its free from fragrance, essential oils, and silicone.

Check it out here.

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The Definitive Guide to All Things Vegan By Drunk Elephant - LIVEKINDLY

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Comparison of concentrated fresh mononuclear cells and …

By daniellenierenberg

Autologous bone marrow mononuclear cell (BMMNC) transplantation has been widely studied in recent years. The fresh cell cocktail in BMMNCs, without going through the in vitro culture process, helps to establish a stable microenvironment for osteogenesis, and each cell type may play a unique role in bone regeneration. Our study compared the efficacy of concentrated fresh BMMNCs and cultured bone marrow-derived mesenchymal stem cells (BMSCs) in Beagle dogs for the first time. Fifteen-millimeter segmental bone defects were created in the animals tibia bones. In BMMNCs group, the defects were repaired with concentrated fresh BMMNCs combined with -TCP (n = 5); in cultured BMSC group, with in vitro cultured and osteo-induced BMSCs combined with -TCP (n = 5); in scaffold-only group, with a -TCP graft alone (n = 5); and in blank group, nothing was grafted (n = 3). The healing process was monitored by X-rays and single photon emission computed tomography. The animals were sacrificed 12months after surgery and their tibias were harvested and analyzed by microcomputed tomography and hard tissue histology. Moreover, the microstructure, chemical components, and microbiomechanical properties of the regenerated bone tissue were explored by multiphoton microscopy, Raman spectroscopy and nanoindentation. The results showed that BMMNCs group promoted much more bone regeneration than cultured BMSC group. The grafts in BMMNCs group were better mineralized, and they had collagen arrangement and microbiomechanical properties similar to the contralateral native tibia bone. These results indicate that concentrated fresh bone marrow mononuclear cells may be superior to in vitro expanded stem cells in segmental bone defect repair. 2020 The Authors. STEM CELLS TRANSLATIONAL MEDICINE published by Wiley Periodicals LLC on behalf of AlphaMed Press.

PubMed

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Comparison of concentrated fresh mononuclear cells and ...

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