By Lorena Anderson, UC Merced

Professor Joel Spencer and his lab have made a huge breakthrough in stem cell research.

Professor Joel Spencer was a rising star in college soccer and now he is an emerging scientist in the world of biomedical engineering, capturing for the first time an image of a hematopoietic stem cell (HSC) within the bone marrow of a living organism.

Everyone knew black holes existed, but it took until last year to directly capture an image of one due to the complexity of their environment, Spencer said. Its analogous with stem cells in the bone marrow. Until now, our understanding of HSCs has been limited by the inability to directly visualize them in their native environment until now.

This work brings an advancement that will open doors to understanding how these cells work which may lead to better therapeutics for hematologic disorders including cancer.

Understanding how HSCs interact within their local environments might help researchers understand how cancers use this same environment in the bone marrow to evade treatment.

Spencer studied biological sciences at UC Irvine where he was the captain of the mens Division 1 soccer team. He initially planned to pursue a career in professional soccer until faculty mentors opened doors for research and introduced Spencer to biophotonics the science that deals with the interactions of light with biological matter.

UC faculty were a big part of my research experience; they became mentors and friends, Spencer said. My first foray into research was as a lab tech, and that is where I met people who were doing biomedical imaging, and it just caught my wonder.

An image of a stem cell in its natural niche

Spencer left his native California to earn his Ph.D. in bioengineering at Tufts University in Boston and took a postdoctoral research position in the Wellman Center for Photomedicine at Massachusetts General Hospital and Harvard Medical School. In Boston, he learned about live-animal imaging and his wonder became a passion.

Now his emphasis is on biomedical optics: building new microscopes and new imaging techniques to visualize and study biological molecules, cells and tissue in their natural niches in living, fully intact small animals.

I work at the interface of engineering and biology. My lab is seeking to answer biological questions that were impossible until the advancements in technology we have seen in the past couple decades, he said. You need to be able to peer inside an organ inside a live animal and see whats happening as it happens.

Based on work conducted at UC Merced and in Boston, he and his collaborators including his grad student Negar Tehrani visualized stem cells inside the bone marrow of live, intact mice.

He and his collaborators have a new paper published in the journal Nature detailing the work they conducted to study HSCs in their native environment in the bone marrow.

We can see how the cells behave in their native niches and how they respond to injuries or stresses which seems to be connected to the constant process of bone remodeling, Tehrani said. Researchers have been trying to answer questions that have gone unanswered for lack of technology, and they have turned to engineering to solve those puzzles.

Its important for researchers to understand the mechanics of stem cells because of the cells potential to regenerate and repair damaged tissue.

Spencer, left, and students from his lab

Spencer returned to California three years ago, joining the Department of Bioengineering in the School of Engineering at UC Merced. Hes also an affiliate of the Health Sciences Research Institute and the NSF CREST Center for Cellular and Biomolecular Machines . This is his third paper in Nature, but the first stemming from work conducted in his current lab.

He didnt come to UC Merced just because he loves biology Spencer also joined the campus because of the students.

Now Im back in the UC system Im a homegrown UC student whos now faculty, Spencer said. As a student within the system I was able to participate in myriad opportunities, including mentorships that advanced my career. Now I try to encourage graduate and undergrad students to follow their dreams. I love being able to give them opportunities its something I really want to do for the next generation.

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Breakthrough in Stem Cell Research: First Image of Niche Environment | Newsroom - UC Merced University News

Bone Marrow Stem Cells Comments Off on Breakthrough in Stem Cell Research: First Image of Niche Environment | Newsroom – UC Merced University News | February 14th, 2020

Santiago Riviello-Goya, MD1; Aldo A. Acosta-Medina, MD2; Sergio I. Inclan-Alarcon, MD3; Sofa Garcia-Miranda, MD2; and Christianne Bourlon, MD, MHSc2

1Department of Medicine, Instituto Nacional de Ciencias Mdicas y Nutricin Salvador Zubirn, Mexico City, Mexico; 2Department of Hematology, Instituto Nacional de Ciencias Mdicas y Nutricin Salvador Zubirn, Mexico City, Mexico; 3Cancer Center, Centro Mdico ABC, Mexico City, Mexico

A 43-year-old male with a history of B-cell acute lymphoblastic leukemia (ALL), who underwent allogeneic hematopoietic stem cell transplantation (HSCT) 5 months prior, presented to the emergency department with a 5-day history of progressive bilateral lower extremity weakness. On physical examination, there were no additional neurologic findings; sensory function and urethral and anal sphincter tone were preserved.

Initial clinical laboratory testing showed peripheral blood cell counts, a peripheral blood smear, and a comprehensive metabolic panel within normal limits. Neuroimaging by computed tomography (CT) and magnetic resonance showed no evidence of acute intracranial processes or lesions suggestive of leukemic relapse. A lumbar puncture for cerebrospinal fluid (CSF) analysis was performed and documented the presence of lymphoid-appearing blasts (Figure 1). Flow cytometry (FC) confirmed central nervous system (CNS) infiltration by B-lineage lymphoid blasts (CD34+, CD45+, CD22+, CD19+, and CD10+) (Figure 2). Bone marrow aspirate and biopsy, including FC evaluation, were negative for systemic relapse. Bone marrow chimerism was 98%.

With a diagnosis of isolated extramedullary leukemic relapse (iEMR), the patient was initiated on weekly intrathecal chemotherapy and was weaned off graft-versus-host disease (GVHD) prophylaxis, achieving CSF clearance after 4 weeks of therapy. Against Hematology service recommendations, the patient declined systemic therapy and received only whole brain radiation therapy (24 Gy in 12 fractions).

The patient experienced remission of neurologic symptoms; however, after 5 months, he developed bilateral testicular tenderness and enlargement. An ultrasound was performed and was suggestive of leukemic infiltration (Figure 3). Chemotherapy with methotrexate and L-asparaginase in addition to radiotherapy to the testes (24 Gy in 12 fractions) was given without complications.

One year after initial CNS iEMR, the patient developed overt bone marrow relapse (BMR), as evidenced by development of bone pain throughout the lumbosacral region, and the appearance of multiple blastic and lytic lesions throughout the appendicular and axial skeleton. A positron emission tomography-CT scan documented abdominal lymphadenopathy (Figure 4). With this rapidly progressive picture, the patient was transitioned to supportive care and died 2 months later.

Is the risk of iEMR following HSCT modified by the choice of conditioning regimen? If so, which of the following approaches would have been the best choice to prevent iEMR in this patient?

A. There is no role of conditioning therapy in preventing iEMRB. Reduced intensity of regimen to favor graft-versus-leukemia (GVL) effectC. Nonmieloablative regimens including fludarabineD. Mieloablative regimens including total body irradiation (TBI)

CORRECT ANSWER: D. Mieloablative regimens including total body irradiation (TBI).

Allogeneic HSCT is an effective treatment for ALL, which can achieve long-term remission and even a potential cure.1 Antineoplastic activity is dependent on both high-dose chemotherapy and graft alloreactivity, with the latter manifested in the GVL effect, and undesirably yet inherently, in GVHD.2 Despite recent advances in allogeneic HSCT strategies, disease relapse is common and remains the most important cause of death in this population. Relapse is reported in 30% to 40% of patients but can increase to 60% in patients who are in a second complete remission (CR) at time of HSCT.2,3

Risk factors for relapse in patients with ALL who have undergone HSCT include disease- and transplant-related features. Reported high-risk disease characteristics include: hyperleukocytosis at diagnosis (white blood cell count >30 x109/L for B-lineage ALL and >100 x109/L for T-lineage ALL); cytogenetics associated with poor outcomes, including chromosome 11 translocations and t(9;22); a short remission timespan; more than a first CR; and a failed or delayed remission after induction therapy.4 In the HSCT population, transplant-related factors should be considered, including alternative donors other than those who are matched related and matched unrelated, the type of conditioning regimen, and the development of GVHD.2

ALL relapse following HSCT most commonly involves the medullary compartment, with a cumulative incidence of 41% at 5 years. Conversely, extramedullary relapse (EMR) is uncommon, with a 5-year cumulative incidence of 11.0% and 5.8% for EMR and iEMR, respectively.5 Due to the rarity of EMR, its prognostic impact remains controversial and the ideal management strategies are a subject of active study.

EMR is associated with poor clinical outcomes; however, the subgroup of patients with iEMR (as presented in this patient case) is gaining attention due to its increasing frequency, its role heralding a systemic relapse, and its clinical behavior showing better survival outcomes compared with BMR and EMR.6-8

Isolated EMR is defined as the presence of clonal blasts in any tissue other than the medullary compartment; bone marrow evaluation must show less than 5% of clonal blasts and a full donor chimerism. Most commonly affected sites include the skin, soft tissues, lymph nodes, and immune sanctuaries including the CNS and testes.1,5,9 Because prevention rather than treatment of relapse is related to improved survival outcomes, it is important to define subgroups of patients who may benefit fromearly intervention with a personalized transplant strategy.

Higher rates of iEMR have been linked to patients of younger age. This is thought to be secondary to: (1) a higher incidence of ALL compared with acute myeloid leukemia (AML) in this age subgroup, the former of which is most associated with EMR; (2) the relative overrepresentation of myelomonocytic/monocytic phenotypes in AML presenting in young individuals; and (3) the higher likelihood of a history of EMR in children compared with adults.1,10

A history of extramedullary (EM) disease, which has consistently been found to impact the development of iEMR, is preexistent in up to half of patients. In 2 out of 3 cases of EMR, disease affects the site of original EM involvement, possibly due to low efficacy of both high-dose chemotherapy and the GVL effect.1,5 An exception to this is CNS involvement, despite being a risk factor for subsequent CNS iEMR, which is commonly reported de novo, reflecting the protective effect of regularly administered prophylaxis to patients at high risk of CNS infiltration.11

The effect of GVHD on risk of iEMR is highly nuanced. Despite its well-known role as a protective factor for BMR, the same effect does not appear to hold true for iEMR.12 Initial reports in this population showed no differences in relapse-free survival regardless of acute or chronic GVHD (cGVHD) or a positive association between extensive cGVHD and iEMR development.10,13 This has led to investigators to postulate that the underlying physiopathology differs among different types of relapse, with decreased expression of human leukocyte antigen (HLA) minor histocompatibility antigens and adhesion molecules and decreased penetration of both immune cells and high-dose chemotherapy to EM sites.14 These mechanisms lead to decreased effectivness of T-cell dependent cytotoxicity of donor lymphocytes as compared with the medullary compartment, with subsequent clone selection and escape, enabling the development of iEMR.6

With the increased use of alternative donors, this has been contested in the haploidentical setting, with a recent report showing significantly increased rates of iEMR in patients who do not develop cGVHD. It is suggested that the role of GVL, coupled with GVHD, in this HLA-mismatched setting could partially explain the added benefit of GVHD in this subgroup. This report also evidenced increased tumor chemosensitivity in patients with EMR compared with BMR, possibly explained by reduced concentrations of conditioning therapy at EM sites.9

Cytogenetics associated with poor outcomes and advanced disease at the time of HSCT were described as risk factors for iEMR in initial cohort studies.1,5,10,15,16 However, recent publications that include alternative-donor HSCT recipients have reported that a haploidentical source could overcome this negative impact.9

The influence of type of conditioning regimen on likelihood of iEMR has been studied only retrospectively, mainly comparing TBI-based versus chemotherapy-based approaches. The landmark paper by Simpson et al showed a significantly elevated rate of iEMR in patients receiving busulfan-based conditioning. This finding has been related to the lack of penetration of drugs into the immune sanctuaries with chemotherapy-only regimens.17

Multiple approaches, including combination and single treatment for iEMR, have been described. Combination therapy including systemic chemotherapy plus local radiotherapy (or in CNS disease, radiation to the craniospinal axis, intrathecal chemotherapy, and systemic chemotherapy) has been associated with higher response rates than single-treatment strategies.9 Nonetheless, the best responses have been observed when combination therapy is followed by a cellular therapy (eg, second allogeneic HSCT, donor leukocyte infusion, and donor stem cell infusion), leading to CR rates of greater than 80%.5,13 Whether this increase in CR rate translates to an increase in survival outcomes remains debatable due to conflicting results in the current literature for iEMR.

Financial Disclosure: The authors have no significant financial interest in or other relationship with the manufacturer of any product or provider of any service mentioned in this article.

Corresponding author:

Christianne Bourlon, MD, MHScVasco de Quiroga No. 15.Belisario Domnguez Seccin XVI

Tlalpan, C.P. 14080, Ciudad de Mxico, Mxico

E-mail: chrisbourlon@hotmail.com

References:

1. Ge L, Ye F, Mao X, et al. Extramedullary relapse of acute leukemia after allogeneic hematopoietic stem cell transplantation: different characteristics between acute myelogenous leukemia and acute lymphoblastic leukemia. Biol Blood Marrow Transplant. 2014;20(7):1040-1047. doi: 10.1016/j.bbmt.2014.03.030.

2. Pavletic SZ, Kumar S, Mohty M, et al. NCI First International Workshop on the Biology, Prevention, and Treatment of Relapse after Allogeneic Hematopoietic Stem Cell Transplantation: report from the Committee on the Epidemiology and Natural History of Relapse following Allogeneic Cell Transplantation. Biol Blood Marrow Transplant. 2010;16(7):871-890. doi: 10.1016/j.bbmt.2010.04.004.

3. Devillier R, Crocchiolo R, Etienne A, et al. Outcome of relapse after allogeneic stem cell transplant in patients with acute myeloid leukemia. Leuk Lymphoma. 2013;54(6):1228-1234. doi: 10.3109/10428194.2012.741230.

4. Hoelzer D, Bassan R, Dombret H, Fielding A, Ribera JM, Buske C; ESMO Guidelines Committee. Acute lymphoblastic leukaemia in adult patients: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2016;27(suppl 5):v69-v82. doi: 10.1093/annonc/mdw025.

5. Shem-Tov N, Saraceni F, Danylesko I, et al. Isolated extramedullary relapse of acute leukemia after allogeneic stem cell transplantation: different kinetics and better prognosis than systemic relapse. Biol Blood Marrow Transplant. 2017;23(7):1087-1094. doi: 10.1016/j.bbmt.2017.03.023.

6. Lee JH, Choi SJ, Lee JH, et al. Anti-leukemic effect of graft-versus-host disease on bone marrow and extramedullary relapses in acute leukemia. Haematologica. 2005;90(10):1380-1388.

7. Xie N, Zhou J, Zhang Y, Yu F, Song Y. Extramedullary relapse of leukemia after allogeneic hematopoietic stem cell transplantation. Medicine (Baltimore). 2019;98(19):e15584. doi: 10.1097/MD.0000000000015584.

8. Shi JM, Meng XJ, Luo Y, et al. Clinical characteristics and outcome of isolated extramedullary relapse in acute leukemia after allogeneic stem cell transplantation: a single-center analysis. Leuk Res. 2013;37(4):372-377. doi: 10.1016/j.leukres.2012.12.002.

9. Mo XD, Kong J, Zhao T, et al. Extramedullary relapse of acute leukemia after haploidentical hematopoietic stem cell transplantation: incidence, risk factors, treatment, and clinical outcomes. Biol Blood Marrow Transplant. 2014;20(12):2023-2028. doi:10.1016/j.bbmt.2014.08.023.

10. Harris AC, Kitko CL, Couriel DR, et al. Extramedullary relapse of acute myeloid leukemia following allogeneic hematopoietic stem cell transplantation: incidence, risk factors and outcomes. Haematologica. 2013;98(2):179-184. doi: 10.3324/haematol.2012.073189.

11. Hamdi A, Mawad R, Bassett R, et al. Central nervous system relapse in adults with acute lymphoblastic leukemia after allogeneic hematopoietic stem cell transplantation. Biol Blood Marrow Transplant. 2014;20(11):1767-1771. doi: 10.1016/j.bbmt.2014.07.005.

12. Giralt SA, Champlin RE. Leukemia relapse after allogeneic bone marrow transplantation: a review. Blood. 1994;84(11):3603-3612.

13. Solh M, DeFor TE, Weisdorf DJ, Kaufman DS. Extramedullary relapse of acute myelogenous leukemia after allogeneic hematopoietic stem cell transplantation: better prognosis than systemic relapse. Biol Blood Marrow Transplant. 2012;18(1):106-112. doi: 10.1016/j.bbmt.2011.05.023.

14. Kolb HJ. Graft-versus-leukemia effects of transplantation and donor lymphocytes. Blood. 2008;112(12):4371-4383. doi: 10.1182/blood-2008-03-077974.

15. Lee KH, Lee JH, Choi SJ, et al. Bone marrow vs extramedullary relapse of acute leukemia after allogeneic hematopoietic cell transplantation: risk factors and clinical course. Bone Marrow Transplant. 2003;32(8):835-842. doi: 10.1038/sj.bmt.1704223.

16. Clark WB, Strickland SA, Barrett AJ, Savani BN. Extramedullary relapses after allogeneic stem cell transplantation for acute myeloid leukemia and myelodysplastic syndrome. Haematologica. 2010;95(6):860-863.

17. Simpson DR, Nevill T, Shepherd JD, et al. High incidence of extramedullary relapse of AML after busulfan/cyclophosphamide conditioning and allogeneic stem cell transplantation. Bone Marrow Transplant. 1998;22(3):259-264. doi: 10.1038/sj.bmt.1701319.

Excerpt from:
Isolated Extramedullary Relapse in Acute Lymphoblastic Leukemia: What Can We Do Before and After Transplant? - Cancer Network

Bone Marrow Stem Cells Comments Off on Isolated Extramedullary Relapse in Acute Lymphoblastic Leukemia: What Can We Do Before and After Transplant? – Cancer Network | February 14th, 2020

To some longevity acolytes, stem cells promise the secret to eternal youth. For a hefty fee, you can pay a startup to extract your own stem cells and cryogenically freeze them, in the hope that they can one day be used in a treatment to help extend your life.

Other firms let you bank stem cells from your babys umbilical cord and placenta after childbirth, if youre convinced the high cost represents an insurance policy against future illness. Or you can follow the example of Sandra Bullock and Cate Blanchett and opt for an anti-ageing cream made with stem cells derived from the severed foreskins of newborn babies in South Korea.

Stem cells are the parent cells which give rise to other cells in our bodies. Since scientists first isolated human embryonic stem cells in a lab and grew them over 20 years ago, they have been mooted as a source of great hope for regenerative medical treatments, including for age-related degenerative conditions such as Parkinsons, Alzheimers, heart disease and stroke.

But apart from a few small-scale examples, the only stem cell-based medical treatment practised in clinics uses haematopoietic stem cells found in the blood and bone marrow which only produce blood cells for transplants in blood cancer patients. These cells are taken from a patients sibling or an unrelated donor, before being infused into a patients blood, or theyre taken from a patients own blood before being reinfused. The procedure has been used to treat blood malignancies for almost half a century, and recently multiple sclerosis too. So how likely is it that the predictions about stem cells' longevity-enhancing powers will become a reality?

In September 2019, Google banned ads for unproven or experimental medical techniques such as most stem cell therapy, citing a rise in bad actors attempting to take advantage of individuals by offering untested, deceptive treatments [that can often] lead to dangerous health outcomes. The decision was welcomed by the International Society for Stem Cell Research, which emphasised that most stem cell interventions remain experimental. Selling treatments before well-regulated clinical trials have been done, the body said, [threatens public] confidence in biomedical research and undermines the development of legitimate new therapies.

Its easy to see how less scrupulous companies can exploit the allure of stem cells, which seem to occupy a place in our collective consciousness as a kind of magical elixir. High hopes for stem cell-based therapies have grown since 2006, when the Japanese biologist Shinya Yamanaka created a new technology to reprogram adult cells, such as skin cells, into a similar state to embryonic stem cells, which are pluripotent, meaning they can develop into any tissue in the body. The Nobel prize-winning breakthrough was hailed as a major step in the study of stem cells without the need for controversial embryo research, and towards the use of these human induced pluripotent stem cells to regenerate damaged or diseased organs or effectively grow new spare parts which could treat the life-limiting and life-shortening illnesses associated with ageing.

Gerontologist Aubrey de Grey, whose Strategies for Engineered Negligible Senescence (SENS) research foundation aims to eliminate ageing-related diseases, thinks the chances well soon have stem cell based therapies are high. For anything that's in clinical trials, you're talking about maybe five years before it's available to the general public, he says, citing stem cell treatments for Parkinsons disease, currently being tested in phase two clinical trials, as one of the developments he thinks is likely to come soonest.

However, given that these trials involve a relatively small number of participants and most clinical trials ultimately fail, his predictions might be overly optimistic. Often described as a maverick, De Grey believes that humans can live forever and there is a 50 per cent chance medical advances of which stem cell therapies will play an important part will make this a reality within the next 17 years. Though living forever, he says, is not the ultimate goal but a rather large side effect of medicine which will successfully prevent or repair the damage that comes with ageing.

For New Jersey-based Robert Hariri, who co-founded Human Longevity Inc, which set its sights more modestly on making 100 the new 60, stem cells derived from placentas present especially exciting opportunities. A biomedical scientist, surgeon and entrepreneur, Hariri says his current venture Celularity which is focused on engineering placental cells, including stem cells, to create drugs for cancer and other conditions is not as concerned about the actual age number, but about preserving human performance as we age and treating the degenerative diseases that rob us of our quality of life.

Many of those working in the field, however, remain cautious in their optimism. Researchers have highlighted the potential risks of giving pluripotent cells to patients, whether they are induced or embryonic, as these cells can develop cancer-causing mutations as they grow.

Davide Danovi, a scientist at Kings College Londons Centre for Stem Cells & Regenerative Medicine, says the path to stem cell-based therapy is very long and full of hurdles. The supply chain involves challenges, he says. On the one hand, allogeneic treatments those with stem cells derived from one individual and expanded into big batches to create cells to treat many individuals have the advantage of being similar to the traditional pharmaceutical business models. The product is clear, its something that comes in a vial and can be scaled up and mass produced, Danovi says. But this treatment can present a greater risk of rejection from the patient, as opposed to the more bespoke autologous option which is more expensive and time-consuming as it involves extracting a patients own stem cells before reprogramming them.

Danovi is most excited by the potential of stem cells to treat age-related macular degeneration. In 2017 Japanese scientist Masayo Takahash led a team that administered transplants of artificially grown retinal cells created from induced pluripotent stem cells taken from donors to five patients with the eye condition, which can cause blindness, and theyre reported to be doing well. The eye, he says seems to be a place where immunity plays less of a role relative to other issues, so you can host cells which come from another individual with fewer problems [of rejection]. But, with other organs such as the liver, he says there are major conceptual problems with creating enough tissue. Its like the clean meat burger - you're talking about a production that is, in many cases, not easy to reach with the current technology.

Hariri believes placentas will solve some of the production challenges crucially, theyre an abundant commodity, with the vast majority thrown out after childbirth. His interest was sparked 20 years ago when his oldest daughter was in the womb: When I saw her first ultrasound in the first trimester, the placenta had already developed into a relatively sizable organ, even though she was just a peanut-sized embryo. Id been taught that the placenta was nothing more than an interface, but [if that was the case], you would expect that it would grow at the same rate as the embryo. His curiosity piqued, he began to see the placenta not as an interface but as a biological factory, where stem cells could be expanded and differentiated to participate in the development of that foetus. That intrigued me and I started to collect placentas and just, you know, basically disassemble them.

Placentas have numerous benefits, he says they dont carry the same ethical controversy as embryonic stem cells, for one thing. Scientists working on embryonic stem cells have to destroy an early embryo, and that option yields them a dozen cells, which have to be culture-expanded in the laboratory into billions of cells. In contrast, the placenta houses, billions and hundreds of billions of cells, which can be expanded as well, but you're starting out with a dramatically larger starting material.

Increasingly, scientists in the anti-ageing sphere are focusing on an approach that seems like the opposite of planting fresh stem cells into our bodies. Experts such as Ilaria Bellantuono at Sheffield Universitys Healthy Lifespan Institute are working towards creating senolytics medication that could kill off our senescent cells, the zombie cells that accumulate in tissues as we age and cause chronic inflammation. I think stem cells are very good for specific disease, where the environment is still young, Bellantuono says, but the data in animal models tells us that senolytics are actually able to delay the onset and reduce the severity of multiple diseases at the same time for example, there is evidence for osteoarthritis, osteoporosis, cardiovascular disease, Alzheimer's, Parkinson's, and diabetes. She explains that while human trials are still in their early stages, senolytics are likely to be more cost-effective than stem cell therapy and the status quo of older patients taking multiple pills for multiple diseases, which can interact with each other. Besides, she adds, they may actually work in tandem with stem-cell based therapies in the future, with senolytics creating a more hospitable environment in tissues to allow stem cells to do their work.

And as for the so-called penis facial? Its far from the only ultra-expensive stem cell skincare making bold anti-ageing claims but youre probably better off saving your money, as you are with the experimental medical treatments on offer. Stem cells are definitely exciting but theyre not the key to eternal youth. At least, not yet.

Robert Harari will be one of the speakers at WIRED Health in London on March 25, 2020. For more details, and to book your ticket, click here

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Are stem cells really the key to making humans live longer? - Wired.co.uk

Bone Marrow Stem Cells Comments Off on Are stem cells really the key to making humans live longer? – Wired.co.uk | February 14th, 2020

VANCOUVER, Washington, Feb. 14, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today continued positive data for its mTNBC and MBC patients.

Metastatic triple-negative breast cancer (mTNBC), an aggressive histological subtype, has a poor prognosis. In addition, metastatic breast cancer (MBC) is breast cancer that has spread beyond the breast and lymph nodes to other organs in the body (typically the bones, liver, lungs, or brain). Both types of cancer pose significant challenges for patients due to their aggressiveness and limited treatment options. An integral part of CytoDyns mission and purpose is to provide effective therapeutic solutions to these patients. Results of the first five patients are as follows:

Patient #1: Enrolled in mTNBC Phase 1b/2 - Injected on 9/27/2019. CTC (circulating tumor cells) dropped to zero in two weeks on 10/11/2019. Total CTC and EMT (Epithelial Mesenchymal Transition in Tumor Metastasis) dropped to zero after about one month of treatment with leronlimab (once-a-week 350 mg dose). After approximately four months of treatment with leronlimab and Carboplatin, the patient had zero CTC+EMT. Furthermore, the patients CT scan indicated a 20% tumor shrinkage within the first few weeks of treatment with leronlimab.

Patient #2: Enrolled in single IND. Patient is MBC with HER2+ stage 4 metastasis to lung, liver, and brain. Patients radiologist cancelled 2nd round of treatment due to leronlimabs effect on shrinking the largest tumor in the brain by 56% and other lesions being stable. Leronlimab has, and continues to be, the only treatment in place since the measurement of brain tumor shrinkage was initiated. Patient was permitted to obtain CTC+EMT test results. After 10 weeks of treatment with leronlimab, this patients CTC+EMT results were zero (results reported on 2/12/2020).

Patient #3: Enrolled on 1/3/2020. This patients CAML counts went down from 45 to 30. CTC+EMT are stable and there has been no change in the total number.

Patient #4: Enrolled on 1/7/2020. This patients total CTC+EMT dropped by 75% in the first two weeks of treatment with leronlimab.

Patient #5: Enrolled on 2/4/2020. This patients CTC+EMT have been recorded upon enrollment and the first results are expected on 2/25/2020.

In addition to the first five patients, enrollment and treatment updates in CytoDyns Phase 2 protocol basket trial under its cancer IND are as follows:

Patient #6: Injected on 2/8/2020 and the first results since enrollment are due by end of February.

Patient #7: Injected on 2/13/2020.

Patients #8, 9 and 10: Completed screening for enrollment.

The patients enrolled in the mTNBC Phase 1b/2 trial continue to demonstrate meaningful results that support the hypothesis regarding leronlimabs mechanism of action, said Bruce Patterson, M.D., chief executive officer and founder of IncellDx, a diagnostic partner and an advisor to CytoDyn. In the four patients (1 with MBC, 3 with TNBC) now with results from leronlimab therapy, patients #1-3 have zero CTCs and zero EMTs and Patient #4, who has been treated with leronlimab for 2 weeks showed a decrease of CTCs and EMTs from 8 to 2. New data from Patient #2 with Stage 4 MBC and who has been treated with 10 weekly doses of leronlimab showed zero CTCs and zero EMTs, in addition to the shrinkage or disappearance of some brain metastases as previously reported.

Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn, added: These findings are extremely promising in light of the success rate of other treatment options. Therapeutic options for patients suffering from breast cancer are highly limited and we look forward to continuing enrollment and exploring leronlimabs potential to treat this devastating disease. Since our basket trial for all solid tumor cancers has been initiated, we are currently screening a prostate cancer patient, and if continued positive clinical results are forthcoming from this patient, we are hopeful that this will clear the path for CytoDyn to file for Breakthrough Therapy designation for all solid tumor cancers. Our mechanism of action is not only focused on the inhibition of metastasis of solid tumor cancers, but also targets the tumor itself through macrophages, angiogenesis and T-reg.

About Triple-Negative Breast CancerTriple-negative breast cancer (TNBC) is a type of breast cancer characterized by the absence of the three most common types of receptors in the cancer tumor known to fuel most breast cancer growthestrogen receptors (ER), progesterone receptors (PR) and the hormone epidermal growth factor receptor 2 (HER-2) gene. TNBC cancer occurs in about 10 to 20 percent of diagnosed breast cancers and can be more aggressive and more likely to spread and recur. Since the triple-negative tumor cells lack these receptors, common treatments for breast cancer such as hormone therapy and drugs that target estrogen, progesterone, and HER-2 are ineffective.

About Leronlimab (PRO 140)The U.S. Food and Drug Administration (FDA) have granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as 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 successfully completed nine clinical trials in over 800 people, including meeting 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 can 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 plays an important role in tumor invasion and metastasis. 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. Additional research is being conducted with leronlimab in the setting of cancer and NASH with plans to conduct additional clinical studies when appropriate.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation and may be important 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 further support the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD and that blocking this receptor from recognizing certain 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.

About CytoDynCytoDyn is a 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 key 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 in 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. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in the first quarter of 2020 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients and plans to initiate a registration-directed study of leronlimab monotherapy indication, which if successful, 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 with no reported drug-related serious adverse events (SAEs). Moreover, results from a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients, with some patients on leronlimab monotherapy remaining virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at http://www.cytodyn.com.

Forward-Looking Statements This 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. The Companys 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 Companys cash position, (ii) the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv) the Companys ability to enter into partnership or licensing arrangements with third parties, (v) the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Companys ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Companys clinical trials, (viii) the results of the Companys 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 Companys 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 Companys 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.

CYTODYN CONTACTSMedia:Grace FotiadesLifeSci Communications[emailprotected](646) 876-5026

Investors: Dave Gentry, CEORedChip CompaniesOffice: 1.800.RED.CHIP (733.2447)Cell: 407.491.4498[emailprotected]

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CytoDyn Reports Continued Positive Clinical Data on its Phase 1b/2 mTNBC and Expanded Access Studies for MBC Ahead of Breakthrough Therapy Designation...

Bone Marrow Stem Cells Comments Off on CytoDyn Reports Continued Positive Clinical Data on its Phase 1b/2 mTNBC and Expanded Access Studies for MBC Ahead of Breakthrough Therapy Designation… | February 14th, 2020

NEW YORK, Feb. 13, 2020 /PRNewswire/ --Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium") announced today that presentations from its targeted conditioning portfolio have been accepted for presentation at the 2020 Transplantation & Cellular Therapy (TCT) Meetings, which brings together thousands of transplant professionals from over 500 transplant centers worldwide. TCT is being held February 19-23, 2020 at the Marriott World Center in Orlando, Florida. Notably, data from the pivotal Phase 3 SIERRA trial of Iomab-B have been selected for an oral presentation.

"We are excited that Iomab-B and the SIERRA trial have once again been selected as an oral presentation at TCT," said Dr. Mark Berger, Chief Medical Officer of Actinium. "We look forward to highlighting the potential benefit that Iomab-B can provide to a patient population with active disease who are otherwise ineligible for BMT. We are confident these findings will be received with great enthusiasm. TCT, which assembles leading transplant physicians from top centers in the United States and worldwide, is the ideal venue to showcase the extremely encouraging findings from the SIERRA trial thus far. In addition, our other conference activities are expected to provide significant exposure for this important trial and invaluable interactions with BMT thought leaders. Through the SIERRA trial, we aspire to change the treatment paradigm for older patients with relapsed or refractory AML to make potentially curative BMT via Iomab-B the standard of care for this patient population that continues to have poor outcomes."

Actinium's TCT Presentations:

Late Breaking Oral Presentation:

Poster Presentation:

About the SIERRA TrialThe SIERRA trial (Study ofIomab-B inElderlyRelapse/RefractoryAcute Myeloid Leukemia) is the only randomized Phase 3 trial that offers BMT (Bone Marrow Transplant) as an option for older patients with active, relapsed or refractory AML or acute myeloid leukemia. BMT is the only potentially curative treatment option for older patients with active relapsed or refractory AML and there is no standard of care for this indication other than salvage therapies. Iomab-B is an ARC (Antibody Radiation-Conjugate) comprised of the anti-CD45 antibody apamistamab and the radioisotope I-131 (Iodine-131). The 20 active SIERRA trial sites in the U.S. and Canada represent many of the leading bone marrow transplant centers by volume. For more information, visit http://www.sierratrial.com.

About Transplantation & Cellular Therapy Meetings (TCT) TCT, formerly known as the BMT Tandem Meetings, are the combined annual meetings of the American Society for Blood and Marrow Transplantation (ASBMT) and the Center for International Blood & Marrow Transplant Research (CIBMTR).Each year the conference brings together several thousand investigators, clinicians, researchers, nurses and other allied health professionals from over 500 transplant centers from over 50 countries around a full scientific program focused on bone marrow transplant and cellular therapies.

About Actinium Pharmaceuticals, Inc. (NYSE: ATNM)Actinium Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing ARCs or Antibody Radiation-Conjugates, which combine the targeting ability of antibodies with the cell killing ability of radiation. Actinium's lead application for our ARCs is targeted conditioning, which is intended to selectively deplete a patient's disease or cancer cells and certain immune cells prior to a BMT or Bone Marrow Transplant, Gene Therapy or Adoptive Cell Therapy (ACT) such as CAR-T to enable engraftment of these transplanted cells with minimal toxicities. With our ARC approach, we seek to improve patient outcomes and access to these potentially curative treatments by eliminating or reducing the non-targeted chemotherapy that is used for conditioning in standard practice currently. Our lead product candidate, I-131 apamistamab (Iomab-B) is being studied in the ongoing pivotal Phase 3Study ofIomab-B inElderlyRelapsed orRefractoryAcute Myeloid Leukemia (SIERRA) trial for BMT conditioning. The SIERRA trial is over fifty percent enrolled and promising single-agent, feasibility and safety data has been highlighted at ASH, TCT, ASCO and SOHO annual meetings. I-131 apamistamab will also be studied as a targeted conditioning agent in a Phase 1/2 anti-HIV stem cell gene therapy with UC Davis and is expected to be studied with a CAR-T therapy in 2020. In addition, we are developing a multi-disease, multi-target pipeline of clinical-stage ARCs targeting the antigens CD45 and CD33 for targeted conditioning and as a therapeutic either in combination with other therapeutic modalities or as a single agent for patients with a broad range of hematologic malignancies including acute myeloid leukemia, myelodysplastic syndrome and multiple myeloma. Ongoing combination trials include our CD33 alpha ARC, Actimab-A, in combination with the salvage chemotherapy CLAG-M and the Bcl-2 targeted therapy venetoclax. Underpinning our clinical programs is our proprietary AWE (Antibody Warhead Enabling) technology platform. This is where our intellectual property portfolio of over 100 patents, know-how, collective research and expertise in the field are being leveraged to construct and study novel ARCs and ARC combinations to bolster our pipeline for strategic purposes. Our AWE technology platform is currently being utilized in a collaborative research partnership with Astellas Pharma, Inc. Website: https://www.actiniumpharma.com/

Forward-Looking Statements for Actinium Pharmaceuticals, Inc.

This press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time.

Contacts:

Investors:Hans Vitzthum LifeSci Advisors, LLCHans@LifeSciAdvisors.com(617) 535-7743

Media:Alisa Steinberg, Director, IR & Corp Commsasteinberg@actiniumpharma.com(646) 237-4087

SOURCE Actinium Pharmaceuticals, Inc.

http://www.actiniumpharma.com/

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Actinium to Highlight Targeted Conditioning Portfolio at 2020 Transplantation & Cellular Therapy Annual Meeting; Phase 3 SIERRA Trial Preliminary...

Bone Marrow Stem Cells Comments Off on Actinium to Highlight Targeted Conditioning Portfolio at 2020 Transplantation & Cellular Therapy Annual Meeting; Phase 3 SIERRA Trial Preliminary… | February 14th, 2020

PHILADELPHIA, Feb. 13, 2020 /PRNewswire/ --Researchers at the University of Pittsburgh and the University of Delaware have been awarded funding and support to accelerate their search for new medicines through an ongoing partnership between global biotechnology leader CSL Behring and the University City Science Center.

CSL Behring awarded Cecelia Yates, Ph.D., from the University of Pittsburgh, and Eleftherios (Terry) Papoutsakis, Ph.D., from the University of Delaware, $250,000 each and an opportunity to work alongside the plasma-based biotech's own experts in an effort to help transform their ideas into groundbreaking therapies to improve patients' health.

CSL Behring, a global leader in treating rare and serious diseases which has its global operational headquarters in King of Prussia, PA, identified the medical researchers utilizing the Science Center's, sourcing innovation framework for technology commercialization, support and infrastructure to efficiently evaluate technologies from multiple institutions.

"Congratulations Drs. Yates and Papoutsakis on being the first recipients of the CSL Behring-Science Center Research Acceleration Initiative," said Bill Mezzanotte, MD, Executive Vice President, Head of Research and Development for CSL Behring. "This initiative is another example of the strength of our partnership with the Philadelphia-based University City Science Center as we look in our 'backyard' for innovative scientific advancements that have the potential to help rare disease patients lead full lives. Our growing R&D organization looks forward to working with Dr. Yates and Dr. Papoutsakis in the years ahead to advance their scientific research."

"The Science Center couldn't be more excited about facilitating the introduction between these talented investigators and CSL Behring," says John Younger, MD, Vice President of Science & Technology at the Science Center. "Our network of universities, biotech, and pharmaceutical companies was built exactly for making these connections not just possible but easy. Supporting the development of new biologics, and new drug and gene delivery systems like those developed by Drs. Papoutsakis and Yates will continue to be an important focus of our team."

The investigators and technologies selected in this inaugural round of the program include:

Cecelia Yates, Ph.D., University of Pittsburgh, for the use of FibroKine biomimetic peptides as potential targeted therapeutic treatment of pulmonary fibrosis.

Fibrotic diseases constitute a significant health problem in the US with the ability to impact any organ that is scarred from chronic disease, including the heart, lung, liver, arteries, and skin. In some cases, progressive and life-threatening diseases follow, but effective therapies don't yet exist. In response, Dr. Yates has developed FibroKine, a chemokine-based class of biomimetic peptides that are potential therapeutic agents for the targeted treatment of tissue fibrosis. Support from CSL Behring will allow the Yates group to test FibroKine peptide ability to effectively treat and halt the progression of pulmonary fibrosis.

Eleftherios (Terry) Papoutsakis, Ph.D., University of Delaware, for exploring the use of cell derived micro-particles and vesicles (MkMPs) for the treatment of thrombocytopenias and in stem-cell targeted gene therapies

Gene delivery to or editing of Hematopoietic (blood) Stem and Progenitor Cells (HSPCs) can provide therapeutic benefit to patients for a variety of genetic hematological disorders, ranging from low platelet count diseases to primary immune deficiencies like Wiskott-Aldrich syndrome. With the support of CSL Behring, Dr. Papoutsakis will investigate the use of human MkMPs: 1) to promote in vivo platelet biogenesis as a potential treatment for thrombocytopenias, and 2) for the in vivo delivery of DNA, RNA, and proteins to HSPCs in gene therapy applications.

In October 2018, the Science Center and CSL Behring joined forces to identify promising technologies and support the commercialization pathways of potential new discoveries. Researchers at academic and research institutions throughout the region were invited to submit proposals for projects with a focus on therapeutics that fit within CSL Behring's five therapeutic areas of expertise: immunology and neurology; hematology and thrombosis; respiratory; cardiovascular and metabolic; and transplant.

Following the success of the initial pilot, the CSL Behring Science Center Research Initiative has expanded and is currently accepting applicationsfrom researchers at 28 institutions across six states with awardees to receive up to $400,000 each.

About CSL BehringCSL Behringis a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients' needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat coagulation disorders, primary immune deficiencies, hereditary angioedema, inherited respiratory disease, and neurological disorders. The company's products are also used in cardiac surgery, burn treatment and to prevent hemolytic disease of the newborn. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited(ASX: CSL; USOTC: CSLLY), headquartered in Melbourne, Australia, employs more than 25,000 people, and delivers its life-saving therapies to people in more than 70 countries. For inspiring stories about the promise of biotechnology, visit Vita CSLBehring.com/vitaand follow us on Twitter.com/CSLBehring.

About the Science CenterLocated in the heart ofuCitySquare, the Science Center is a mission-driven nonprofit that commercializes promising technology, cultivates talent and convenes people to inspire action. For over 50 years, the Science Center has supported startups, research, and economic development across the emerging technology sectors. As a result, Science Center-supported companies account for one out of every 100 jobs in the Greater Philadelphia region and drive $13 billion in economic activity in the region annually. By providing the right help at the right time, the Science Center is turning bright ideas into businesses and nurturing a workforce to support our 21st century economy. For more information about the Science Center, go towww.sciencecenter.org

View original content:http://www.prnewswire.com/news-releases/university-city-science-center-partnership-with-csl-behring-accelerates-the-search-for-new-biotherapies-at-the-university-of-pittsburgh-and-the-university-of-delaware-301004508.html

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University City Science Center partnership with CSL Behring accelerates the search for new biotherapies at the University of Pittsburgh and the...

Cardiac Stem Cells Comments Off on University City Science Center partnership with CSL Behring accelerates the search for new biotherapies at the University of Pittsburgh and the… | February 14th, 2020

Regenerative Medicine Market: Snapshot

Regenerative medicine is a part of translational research in the fields of molecular biology and tissue engineering. This type of medicine involves replacing and regenerating human cells, organs, and tissues with the help of specific processes. Doing this may involve a partial or complete reengineering of human cells so that they start to function normally.

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Regenerative medicine also involves the attempts to grow tissues and organs in a laboratory environment, wherein they can be put in a body that cannot heal a particular part. Such implants are mainly preferred to be derived from the patients own tissues and cells, particularly stem cells. Looking at the promising nature of stem cells to heal and regenerative various parts of the body, this field is certainly expected to see a bright future. Doing this can help avoid opting for organ donation, thus saving costs. Some healthcare centers might showcase a shortage of organ donations, and this is where tissues regenerated using patients own cells are highly helpful.

There are several source materials from which regeneration can be facilitated. Extracellular matrix materials are commonly used source substances all over the globe. They are mainly used for reconstructive surgery, chronic wound healing, and orthopedic surgeries. In recent times, these materials have also been used in heart surgeries, specifically aimed at repairing damaged portions.

Cells derived from the umbilical cord also have the potential to be used as source material for bringing about regeneration in a patient. A vast research has also been conducted in this context. Treatment of diabetes, organ failure, and other chronic diseases is highly possible by using cord blood cells. Apart from these cells, Whartons jelly and cord lining have also been shortlisted as possible sources for mesenchymal stem cells. Extensive research has conducted to study how these cells can be used to treat lung diseases, lung injury, leukemia, liver diseases, diabetes, and immunity-based disorders, among others.

Global Regenerative Medicine Market: Overview

The global market for regenerative medicine market is expected to grow at a significant pace throughout the forecast period. The rising preference of patients for personalized medicines and the advancements in technology are estimated to accelerate the growth of the global regenerative medicine market in the next few years. As a result, this market is likely to witness a healthy growth and attract a large number of players in the next few years. The development of novel regenerative medicine is estimated to benefit the key players and supplement the markets growth in the near future.

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Global Regenerative Medicine Market: Key Trends

The rising prevalence of chronic diseases and the rising focus on cell therapy products are the key factors that are estimated to fuel the growth of the global regenerative medicine market in the next few years. In addition, the increasing funding by government bodies and development of new and innovative products are anticipated to supplement the growth of the overall market in the next few years.

On the flip side, the ethical challenges in the stem cell research are likely to restrict the growth of the global regenerative medicine market throughout the forecast period. In addition, the stringent regulatory rules and regulations are predicted to impact the approvals of new products, thus hampering the growth of the overall market in the near future.

Global Regenerative Medicine Market: Market Potential

The growing demand for organ transplantation across the globe is anticipated to boost the demand for regenerative medicines in the next few years. In addition, the rapid growth in the geriatric population and the significant rise in the global healthcare expenditure is predicted to encourage the growth of the market. The presence of a strong pipeline is likely to contribute towards the markets growth in the near future.

Global Regenerative Medicine Market: Regional Outlook

In the past few years, North America led the global regenerative medicine market and is likely to remain in the topmost position throughout the forecast period. This region is expected to account for a massive share of the global market, owing to the rising prevalence of cancer, cardiac diseases, and autoimmunity. In addition, the rising demand for regenerative medicines from the U.S. and the rising government funding are some of the other key aspects that are likely to fuel the growth of the North America market in the near future.

Furthermore, Asia Pacific is expected to register a substantial growth rate in the next few years. The high growth of this region can be attributed to the availability of funding for research and the development of research centers. In addition, the increasing contribution from India, China, and Japan is likely to supplement the growth of the market in the near future.

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Global Regenerative Medicine Market: Competitive Analysis

The global market for regenerative medicines is extremely fragmented and competitive in nature, thanks to the presence of a large number of players operating in it. In order to gain a competitive edge in the global market, the key players in the market are focusing on technological developments and research and development activities. In addition, the rising number of mergers and acquisitions and collaborations is likely to benefit the prominent players in the market and encourage the overall growth in the next few years.

Some of the key players operating in the regenerative medicine market across the globe are Vericel Corporation, Japan Tissue Engineering Co., Ltd., Stryker Corporation, Acelity L.P. Inc. (KCI Licensing), Organogenesis Inc., Medtronic PLC, Cook Biotech Incorporated, Osiris Therapeutics, Inc., Integra Lifesciences Corporation, and Nuvasive, Inc. A large number of players are anticipated to enter the global market throughout the forecast period.

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Regenerative Medicine Market Projected to Hit at a Strong CAGR Between Forecast Period 2017-2025 - Redhill Local Councillors

Cardiac Stem Cells Comments Off on Regenerative Medicine Market Projected to Hit at a Strong CAGR Between Forecast Period 2017-2025 – Redhill Local Councillors | February 14th, 2020

Technological innovations in the area of stem cell therapy and tissue engineering has led to rapid growth of the regenerative medicine market size.

Regenerative medicine is a comparatively new area of science that involves the restoration of damaged cells, tissues or organs by applying cell therapy, tissue engineering, immunotherapy or gene therapy techniques. On contrary to the present clinical therapeutics that act on slowing the disease progression or relieve symptoms, regenerative medication has a promising therapeutic approach of restoring the function and structure of damaged organs and tissues.

The global regenerative medicine market is expected to witness significant growth during the forecast period,due to the increase in the prevalence of chronic diseases, orthopaedic injuries, genetic disorders, growing aging population, increasing government funding along with the private funding in the research & development of regenerative medicines with the advancement in nanotechnology based drug delivery system, and moderate healthcare reforms. Currently, major breakthrough in the area is the development of tissue engineered trachea, transplantation of retinal pigment differentiated by stem cell based therapy to treat age-related macular degeneration.

However, recently research labs have started to focus on regenerating solid organs such as heart, kidney, lungs and other organs to curb the problems associated with organ transplantation.

The rise in number of regulatory approvals of regenerative medications is expected to further drive the regenerative medicine market during the forecast period. Moreover, there has been strategic partnership between many companies that has encouraged increased involvement of these companies in the global market.

Improvised drug delivery systems for regenerative medicines is also expected to contribute to the growth of the global market.

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The key factors which drive the growth of the global market include increase in the demand of orthopaedic surgeries, government healthcare reforms in certain countries such as the U.S. and Canada, aging population, rise in chronic diseases, increasing prevalence of bone and joint diseases, and innovations in nanotechnology that aids in drug delivery mechanism.

Globally, North America is the largest market for regenerative medicine followed by Europe. The largest regenerative medicine market size of North America is attributed to the high rate of incidence of cardiac disorders, autoimmune diseases, and increasing prevalence of cancer patients among the American population.

Additionally, the involvement of government organization for funding in the area of R&D of regenerative medicines, technological advancement and other policies are driving the growth of the North American market.

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Regenerative Medicine Market trends, leaders, segment analysis and forecast to 2030 described in a new market report - WhaTech Technology and Markets...

Cardiac Stem Cells Comments Off on Regenerative Medicine Market trends, leaders, segment analysis and forecast to 2030 described in a new market report – WhaTech Technology and Markets… | February 14th, 2020

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 KEYNOTE-355 trial investigating KEYTRUDA, Mercks anti-PD-1 therapy, in combination with chemotherapy met one of its dual primary endpoints of progression-free survival (PFS) in patients with metastatic triple-negative breast cancer (mTNBC) whose tumors expressed PD-L1 (Combined Positive Score [CPS] 10). Based on an interim analysis conducted by an independent Data Monitoring Committee (DMC), first-line treatment with KEYTRUDA in combination with chemotherapy (nab-paclitaxel, paclitaxel or gemcitabine/carboplatin) demonstrated a statistically significant and clinically meaningful improvement in PFS compared to chemotherapy alone in these patients. Based on the recommendation of the DMC, the trial will continue without changes to evaluate the other dual primary endpoint of overall survival (OS). The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies; no new safety signals were identified.

Triple-negative breast cancer is an aggressive malignancy. It is very encouraging that KEYTRUDA in combination with chemotherapy has now demonstrated positive results as both a first-line treatment in the metastatic setting with this trial, and as neoadjuvant therapy in the KEYNOTE-522 trial, said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. We look forward to sharing these findings with the medical community at an upcoming congress and discussing them with the FDA and other regulatory authorities.

The KEYTRUDA breast cancer clinical development program encompasses several internal and external collaborative studies. In addition to KEYNOTE-355, in TNBC these include the ongoing registration-enabling studies KEYNOTE-242 and KEYNOTE-522.

About KEYNOTE-355

KEYNOTE-355 is a randomized, two-part, Phase 3 trial (ClinicalTrials.gov, NCT02819518) evaluating KEYTRUDA in combination with one of three different chemotherapies (investigators choice of either nab-paclitaxel, paclitaxel or gemcitabine/carboplatin) compared with placebo plus one of the three chemotherapy regimens for the treatment of locally recurrent inoperable or mTNBC that has not been previously treated with chemotherapy in the metastatic setting. Part 1 of the study was open-label and evaluated the safety and tolerability of KEYTRUDA in combination with either nab-paclitaxel, paclitaxel or gemcitabine/carboplatin in 30 patients. Part 2 of KEYNOTE-355 was double-blinded, with dual primary endpoints of OS and PFS in all participants and in participants whose tumors expressed PD-L1 (CPS 1 and CPS 10). The secondary endpoints include objective response rate (ORR), duration of response (DOR), disease control rate (DCR) and safety.

Part 2 of KEYNOTE-355 enrolled 847 patients who were randomized to receive KEYTRUDA (200 mg intravenously [IV] on day 1 of each 21-day cycle) plus nab-paclitaxel (100 mg/m2 IV on days 1, 8 and 15 of each 28-day cycle), paclitaxel (90 mg/m2 IV on days 1, 8 and 15 of each 28-day cycle) or gemcitabine/carboplatin (1,000 mg/m2 [gemcitabine] and Area Under the Curve [AUC] 2 [carboplatin] on days 1 and 8 of each 21-day cycle); or placebo (normal saline on day 1 of each 21-day cycle) plus nab-paclitaxel (100 mg/m2 IV on days 1, 8 and 15 of each 28-day cycle), paclitaxel (90 mg/m2 IV on days 1, 8 and 15 of each 28-day cycle) or gemcitabine/carboplatin (1,000 mg/m2 [gemcitabine] and AUC 2 [carboplatin] on days 1 and 8 of each 21-day cycle).

About Triple-Negative Breast Cancer (TNBC)

TNBC is an aggressive type of breast cancer that characteristically has a high recurrence rate within the first five years after diagnosis. While some breast cancers may test positive for estrogen receptor, progesterone receptor or human epidermal growth factor receptor 2 (HER2), TNBC tests negative for all three. As a result, TNBC does not respond to therapies targeting these markers, making it more difficult to treat. Approximately 15-20% of patients with breast cancer are diagnosed with TNBC.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,000 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) 10], as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High (MSI-H) Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)

Immune-Mediated Hepatitis

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hepatotoxicity in Combination With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.

Immune-Mediated Endocrinopathies

KEYTRUDA can cause adrenal insufficiency (primary and secondary), hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Adrenal insufficiency occurred in 0.8% (22/2799) of patients, including Grade 2 (0.3%), 3 (0.3%), and 4 (<0.1%). Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%) receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.

Monitor patients for signs and symptoms of adrenal insufficiency, hypophysitis (including hypopituitarism), thyroid function (prior to and periodically during treatment), and hyperglycemia. For adrenal insufficiency or hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 adrenal insufficiency or hypophysitis and withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 adrenal insufficiency or hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.

Immune-Mediated Skin Reactions

Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

Other Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barr syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma, and postmarketing use.

Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients. Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic HSCT after treatment with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT after KEYTRUDA, 6 (26%) developed graft-versus-host disease (GVHD) (1 fatal case) and 2 (9%) developed severe hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning (1 fatal case). Cases of fatal hyperacute GVHD after allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptorblocking antibody before transplantation. Follow patients closely for early evidence of transplant-related complications such as hyperacute graft-versus-host disease (GVHD), Grade 3 to 4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease (VOD), and other immune-mediated adverse reactions.

In patients with a history of allogeneic HSCT, acute GVHD (including fatal GVHD) has been reported after treatment with KEYTRUDA. Patients who experienced GVHD after their transplant procedure may be at increased risk for GVHD after KEYTRUDA. Consider the benefit of KEYTRUDA vs the risk of GVHD in these patients.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with a PD-1 or PD-L1 blocking antibody in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).

In KEYNOTE-002, KEYTRUDA was permanently discontinued due to adverse reactions in 12% of 357 patients with advanced melanoma; the most common (1%) were general physical health deterioration (1%), asthenia (1%), dyspnea (1%), pneumonitis (1%), and generalized edema (1%). The most common adverse reactions were fatigue (43%), pruritus (28%), rash (24%), constipation (22%), nausea (22%), diarrhea (20%), and decreased appetite (20%).

In KEYNOTE-054, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). Serious adverse reactions occurred in 25% of patients receiving KEYTRUDA. The most common adverse reaction (20%) with KEYTRUDA was diarrhea (28%).

In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).

In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein-bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407.

In KEYNOTE-042, KEYTRUDA was discontinued due to adverse reactions in 19% of 636 patients with advanced NSCLC; the most common were pneumonitis (3%), death due to unknown cause (1.6%), and pneumonia (1.4%). The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia (7%), pneumonitis (3.9%), pulmonary embolism (2.4%), and pleural effusion (2.2%). The most common adverse reaction (20%) was fatigue (25%).

In KEYNOTE-010, KEYTRUDA monotherapy was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC; the most common was pneumonitis (1.8%). The most common adverse reactions (20%) were decreased appetite (25%), fatigue (25%), dyspnea (23%), and nausea (20%).

Adverse reactions occurring in patients with SCLC were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent.

In KEYNOTE-048, KEYTRUDA monotherapy was discontinued due to adverse events in 12% of 300 patients with HNSCC; the most common adverse reactions leading to permanent discontinuation were sepsis (1.7%) and pneumonia (1.3%). The most common adverse reactions (20%) were fatigue (33%), constipation (20%), and rash (20%).

In KEYNOTE-048, when KEYTRUDA was administered in combination with platinum (cisplatin or carboplatin) and FU chemotherapy, KEYTRUDA was discontinued due to adverse reactions in 16% of 276 patients with HNSCC. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonia (2.5%), pneumonitis (1.8%), and septic shock (1.4%). The most common adverse reactions (20%) were nausea (51%), fatigue (49%), constipation (37%), vomiting (32%), mucosal inflammation (31%), diarrhea (29%), decreased appetite (29%), stomatitis (26%), and cough (22%).

In KEYNOTE-012, KEYTRUDA was discontinued due to adverse reactions in 17% of 192 patients with HNSCC. Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. The most common adverse reactions (20%) were fatigue, decreased appetite, and dyspnea. Adverse reactions occurring in patients with HNSCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of facial edema and new or worsening hypothyroidism.

In KEYNOTE-087, KEYTRUDA was discontinued due to adverse reactions in 5% of 210 patients with cHL. Serious adverse reactions occurred in 16% of patients; those 1% included pneumonia, pneumonitis, pyrexia, dyspnea, GVHD, and herpes zoster. Two patients died from causes other than disease progression; 1 from GVHD after subsequent allogeneic HSCT and 1 from septic shock. The most common adverse reactions (20%) were fatigue (26%), pyrexia (24%), cough (24%), musculoskeletal pain (21%), diarrhea (20%), and rash (20%).

In KEYNOTE-170, KEYTRUDA was discontinued due to adverse reactions in 8% of 53 patients with PMBCL. Serious adverse reactions occurred in 26% of patients and included arrhythmia (4%), cardiac tamponade (2%), myocardial infarction (2%), pericardial effusion (2%), and pericarditis (2%). Six (11%) patients died within 30 days of start of treatment. The most common adverse reactions (20%) were musculoskeletal pain (30%), upper respiratory tract infection and pyrexia (28% each), cough (26%), fatigue (23%), and dyspnea (21%).

In KEYNOTE-052, KEYTRUDA was discontinued due to adverse reactions in 11% of 370 patients with locally advanced or metastatic urothelial carcinoma. Serious adverse reactions occurred in 42% of patients; those 2% were urinary tract infection, hematuria, acute kidney injury, pneumonia, and urosepsis. The most common adverse reactions (20%) were fatigue (38%), musculoskeletal pain (24%), decreased appetite (22%), constipation (21%), rash (21%), and diarrhea (20%).

In KEYNOTE-045, KEYTRUDA was discontinued due to adverse reactions in 8% of 266 patients with locally advanced or metastatic urothelial carcinoma. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.9%). Serious adverse reactions occurred in 39% of KEYTRUDA-treated patients; those 2% were urinary tract infection, pneumonia, anemia, and pneumonitis. The most common adverse reactions (20%) in patients who received KEYTRUDA were fatigue (38%), musculoskeletal pain (32%), pruritus (23%), decreased appetite (21%), nausea (21%), and rash (20%).

In KEYNOTE-057, KEYTRUDA was discontinued due to adverse reactions in 11% of 148 patients with high-risk NMIBC. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.4%). Serious adverse reactions occurred in 28% of patients; those 2% were pneumonia (3%), cardiac ischemia (2%), colitis (2%), pulmonary embolism (2%), sepsis (2%), and urinary tract infection (2%). The most common adverse reactions (20%) were fatigue (29%), diarrhea (24%), and rash (24%).

Adverse reactions occurring in patients with gastric cancer were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

Adverse reactions occurring in patients with esophageal cancer were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

In KEYNOTE-158, KEYTRUDA was discontinued due to adverse reactions in 8% of 98 patients with recurrent or metastatic cervical cancer. Serious adverse reactions occurred in 39% of patients receiving KEYTRUDA; the most frequent included anemia (7%), fistula, hemorrhage, and infections [except urinary tract infections] (4.1% each). The most common adverse reactions (20%) were fatigue (43%), musculoskeletal pain (27%), diarrhea (23%), pain and abdominal pain (22% each), and decreased appetite (21%).

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Merck's KEYTRUDA (pembrolizumab) in Combination with Chemotherapy Met Primary Endpoint of Progression-Free Survival (PFS) as First-Line Treatment for...

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TMRR, in its recent market report, suggests that the Induced Pluripotent Stem Cells market report is set to exceed US$ xx Mn/Bn by 2029. The report finds that the Induced Pluripotent Stem Cells market registered ~US$ xx Mn/Bn in 2018 and is spectated to grow at a healthy CAGR over the foreseeable period. This Induced Pluripotent Stem Cells market study considers 2018 as the base year, 2019 as the estimated year, and 2019 2029 as the forecast timeframe.

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Lineage Cell Therapeutics and AgeX Therapeutics have in December 2019 announced that they have applied for a patent for a new method for generating iPSCs. These are based on NIH-approved human cell lines, and have been undergoing clinical-stage programs in the treatment of dry macular degeneration and spinal cord injuries. The companies claim to include multiple techniques for reprogramming of animal somatic cells.

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In the rush to get ready for work or kick back in front of Netflix at night, its easy to forget to look after your skin. But as winter bites, its time to step up your skincare routine, or risk developing dry, flaky and uncomfortable skin.

Of course, everyones skin is different and one mans rich moisturiser is anothers potential acne, but from vitamin-infused face washes, to SPF and face oil, weve got something to keep everyones skin looking its best.

(Image credit: Mr Porter)

The best mist to keep your skin juicy

+Great for freshening up+Contains hyaluronic acid

If you work in a highly heated or air-conditioned office and you have dry or dehydrated skin, youll need a little something to keep you skin happy. Face mists are brilliant because you can spritz and go without any mess or a mirror. Dr Barbara Sturms hydrating face mist is infused with hyaluronic acid which is great for hydrating dry and dehydrated skin, as well as purslane extract to nourish skin while protecting cells from free radicals. If thats not enough, its also packed with detoxifying extracts such as lemon, aloe vera and broccoli to minimise the effects of pollution and stress.

(Image credit: Mr Porter)

The best SPF to block harmful rays

+SPF 50+Great price

Whether youre whooshing down ski slopes or going for a wintery walk, an SPF is essential to block harmful rays and to keep you looking younger for longer. Jaxon Lanes Rain or Shine moisturising sunscreen is designed to shield your skin from UVA and UBV rays and offers SPF 50+ protection. Lightweight and non-greasy, it's infused with vitamin E, hyaluronic acid, green tea, liquorice root and ginseng so it not only protects but moisturises and enlivens your skin too.

(Image credit: Mr Porter)

Best deep-cleaning cleanser

+Great price point+Deep cleaning power of charcoal+Suitable for all face types

Washing your face in the winter isnt always the most pleasurable experience if your bathroom is cold. But a nice face wash can help. Clinque for Mens charcoal face wash harnesses the deep-cleaning power of charcoal, which is great for all skin types, especially those with slightly greasy complexions. The detoxifying gel formula is designed to work into a foam and draw out dirt, oil and impurities but isnt drying. Like all Clinque products its non-scented, which makes it a winner for sensitive skin too.

(Image credit: Mr Porter)

Best for the winter sports

+Hydrating, soothing solution+Designed to protect

Gliding down ski slopes and playing in powdery snow may fun, but a dry, red face blasted by the wind and sun isnt, so you definitely dont want to go off-piste with your skincare. If youre going skiing or are spending lots of time in the great but freezing outdoors, try Dr Barbara Sturms aptly-named Ski Cream. Its definitely not cheap, but it does promise a lot, acting as a protective shield against wind and extreme climates. Suitable for all skin types, the cream contains balloon vine, blackcurrant oil and purslane to soothe skin and reduce redness, while shea butter and jojoba oil lock in moisture.

(Image credit: Mr Porter)

The best moisturising serum

+Natural ingredients+Lighter than creams+Beautiful packaging

-Empty List

Aesop may be a favourite on Instagram thanks to its seriously stylish packaging, but the skincare brands parsley seed range packs a botanical punch. The anti-oxidant serum is a lighter alternative to creams and can be used daily after cleaning. The aloe-vera based formula contains other botanical extracts, such as parsley and grape seed oils to soften and moisturise. Plus, its designed to give skin strength and flight of environmental aggressors, which is ideal for winter months and city living alike. Its a stylish skincare solution that wont break the bank.

(Image credit: Mr Porter)

Best for brightening the complexion

+Exfoliates and brightens in one+Can help with pigmentation problems+A good multitasker

You remember to eat your five a day, but vitamin-infused skincare is great for keeping your face looking good too. 111SKINs vitamin C brightening cleanser is a great multitasker, tackling lots of issues in the time it takes to wash your face. A great addition to your morning routine during the winter months, its packed with radiance-boosting vitamin C to help reduce hyper-pigmentation, age spots and uneven skin tone. The exfoliating formula promises leaves your complexion looking clear, even and illuminated, which isnt bad for a quick scrub. Its not cheap, but it might just work miracles.

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The best anti-ageing moisturiser

+High tech formula+Free from parabens, sulphates and gluten+For all skin types

Not all moisturisers are created equal. Sure, some are a couple of quid and do a little to keep your skin soft, but others, like MALIN + GOETZ advanced renewal moisturiser do much more. Of course, all this comes at a cost and the stylish brands high-tech daily moisturiser is pretty expensive. But its blended with antioxidant-rich meadowfoam seed oil and a combination of sugar molecules, barley and sodium hyaluronate to reduce the appearance of fine lines and wrinkles. Meanwhile, linseed extract, which is rich in Omega-3 fatty acids, trap water molecules to make your skin look healthier and plumper, and apple stem cell protects against harsh environments, which is ideal in winter.

(Image credit: Mr Porter)

Best moisturiser for dry and sensitive skin

+Hypoallergenic and gentle+Good for everyday use+Also has some anti-ageing benefits

Everyones skin needs a little extra TLC in the colder months, but those with dry and sensitive complexions can really suffer as chilly winds and harsh heating take their toll. But, PERRICONE MDs hypoallergenic nourishing moisturiser can help. Designed for specifically for dry and sensitive skin, its hypoallergenic and paraben-free, and harnesses the antioxidant properties of vitamin E along with with nourishing olive polyphenols. Gentle enough for everyday use, the brand also claims its good for keeping fine lines and wrinkles at bay.

(Image credit: Mr Porter)

Best lip balm for outdoors

+SPF 30+Water-resistant+Contains natural oils

If youre hitting the slopes or spend a lot of time outside, its important to protect your lips from the elements to avoid them becoming chapped, or sunburnt if theres snow around. Shiseidos Suncare UV Lip Color Splash SPF30 may be a bit of a mouthful, but it will protect your lips admirably. The balm is infused with natural oils to lock in moisture, as well as that all-important SPF protection. It costs considerably more than the likes of Carmex, but its water resistant, you wont need to apply it too often.

(Image credit: Mr Porter)

Best scrub for exfoliating

+Soothing and brightening+Uses sand for exfoliation

-Empty List

Regular exfoliation helps keeps skin healthy and clear, and when done before shaving can reduce bumps and irritation. While its important all year round, its great for preventing patches of dry skin building up and blocking pores in the winter and can make your complexion look brighter. Anthonys facial scrub is formulated with boro boro sand to remove dead cells, as well as soothing aloe vera, algae and chamomile. Antioxidant-rich Vitamin C is also included to protect from environmental stressors and brighten the complexion. The scrub is a handy multitasker and offers a lot of bang for its buck.

(Image credit: Mr Porter)

The best luxury hand cream

+Trendy fragrance+Easily absorbed formula+Luxe packaging

Its not just your face you need to look after in the cold and a hand cream is essential. Byredos Tulipmania hand cream is one of the trendiest options out there. Named after the infamous "tulip mania" period during the Dutch Golden Age when the flowers were in high demand, the cream is lightly fragranced with notes of Freesia and Blond Woods. Byredos hand cream is formulated with moisturising ingredients and has a gel-like consistency that's quick-drying and absorbent, which is a big selling point for busy men and women alike.

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Winter skincare routine: products to protect your face from cold weather - T3

Skin Stem Cells Comments Off on Winter skincare routine: products to protect your face from cold weather – T3 | February 13th, 2020

INDIANAPOLIS (WISH)A near north side representative called for a crackdown on crime along the 38th Street corridor, between Capitol Avenue and Meridian Street, weeks after a News 8 report highlighted a string of incidents at an area McDonalds.

The restaurant, located at 37 W 38th St, shares a facility with a BP gas station convenience store.

Drivers and restaurant regulars described shootings, stabbings, fights and an attack on the McDonalds franchise owner near 38th and Illinois streets.

Annually, there are hundreds of [police] runs to this area, city-county council member John Barth said Sunday night in a Tweet. Historically, many runs have been attributed to the BP/McDonalds.

In the six-part Tweet thread, Barth detailed plans to hold monthly neighborhood meetings, review data-driven crime research and combat addiction-related issues.

Conversations with community leaders and police officers led him to believe substance abuse and addiction were significant contributing factors to violent crime along 38th Street, he told News 8.

I did a ride-along with the IMPD and spent 8 hours driving all around this area, Barth said Wednesday. And what I hear, over and over, is an increasing concern about substance abuse and the need for enhanced treatment options.

Some community members pointed to a disconnect between what they described as city hall narratives and real neighborhood needs.

Talk to the people and really get their point of view, said Diamond Taylor, a Chicago native who relocated to the near north side of Indianapolis. Everybody in this area is not homeless. Everybody in this area is not on drugs. They are not alcoholics. Theyre very good, hardworking people that live here [and] require assistance from the higher-ups; and they havent been getting it.

Lavorah Brady, a longtime resident, said she believed increased business investments and youth programs would be more beneficial to the community than an anti-drug campaign.

A lot of the people dont have good examples to follow, Brady told News 8. If [city leaders] could do more in the communitymaybe open up more community centers where the people have positive things to doI think it would make a world of difference.

There are a variety of causes for the crime along [the 38th Street] corridor, Barth acknowledged.

Drugs and violence were not contained within the corridor. Residential areas throughout his district had been impacted by rising crime rates, including the Crown Hill, Butler Tarkington and Meridian-Kessler neighborhoods, he said.

Members of the Butler Tarkington Neighborhood Association collaborated with gas station and restaurant franchise owners to implement new security measures following Januarys assault.

I am thankful that there are so many people in my district who want to focus on these issues and work together at the grass-roots level, Barth Tweeted.

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Makeup artist shares her FOUR favorite eye creams that you CANNOT buy in a store - WISHTV.com

Skin Stem Cells Comments Off on Makeup artist shares her FOUR favorite eye creams that you CANNOT buy in a store – WISHTV.com | February 13th, 2020

The defense for Joseph Sentore Coleman Jr. rested their case Wednesday with witnesses who contradicted previous statements by the prosecutions witnesses.

Both sides of the aisle are expected to make their closing statements today, before the jury is let out to deliberate the verdict in the case against Coleman, 38.

Coleman, who allegedly robbed and murdered Christopher Wilkins on Aug. 30, 2016, at 505 Park Ave., is already serving two life sentences for a double homicide on Halloween 2016.

Previously unknown to the jury, Louis Martin, frequent visitor of the Park Avenue residence, was called by Jeana Longo, Colemans attorney.

As Coleman and James Rooks allegedly entered the Park Avenue home with the intention of robbing the known drug dealers, Wilkins and Savoy Jennings, Martin said he was just waking up in Jeff Greenes adjacent bedroom from a long night of doing drugs and watching movies.

I was sitting in a chair, just closing my eyes, said Martin, when he heard shouts from the second bedroom.

I aint got nothing, I aint got nothing,' he said a voice shouted.

Then a pop it was a gunshot, said Martin.

Peering out from inside the room, he said two masked people came out of the room and looked at the body of Wilkins before running out.

One was short, slim and was built, he said. One was taller with really dark skin neither of them had dreadlocks.

Martin said he was familiar with Coleman from passing him in the street, but was not a friend of his.

However, Martin said he was familiar enough with Coleman that if his face were covered in a mask that he would know.

When they left, I waited two to three seconds. I see Chris on the floor, he said. I shook him, but Wilkins didnt move.

Martin said he alerted Jeff Greene before he left. The situation had traumatized him.

Ill be honest, I needed a drink to calm down, so I went to the bar, he said.

Later that day in initial police interviews, Martin told police that he drank about a six-pack of beer.

Martin gave a description of the men he thought murdered Wilkins for sketches to be made of their faces after police insisted, he said.

You cant make out their features, but I know what I saw, he said.

Martin said he suspected that one of the masked men was Jamal Brown, who previously testified to have given Coleman the layout of the building and advice on the chances of a successful robbery.

The defense also called John Greene, brother of Jeff Greene, and who lived in the second floor apartment of 505 Park Ave.

He too said he doubted Coleman committed the crime.

(Coleman) had been there plenty of times, he said, and didnt need help figuring out the layout of the home.

John Greene testified that he had seen Brown a native of New York wearing a hat similar to the one found at the scene. Namely, a Brooklyn Dodgers baseball hat.

Although Wilkins killer is still legally unproven, Dr. Barbara Bollinger, the forensic pathologist who conducted the autopsy on Wilkins, said she knew the man died immediately from the gunshot.

The projectile entered Wilkins brain near his left earlobe, passed through his cerebellum and brain stem, which collectively control balance, coordinating movement and breathing.

I think this would have incapacitated him within the span of seconds, she said.

Additionally, the gunshot caused stippling, she said, or abrasions from unburned gunpowder or debris, which typically indicates the gun was 12 inches to three feet away.

Colemans DNA was found on both the hat and a cut-off pant leg, which were used as disguises in the crime and discarded at the scene, said Regina Kuzero and Brittney Lenig, forensic scientists with the Pennsylvania State police, and Jennifer Bracamontes, a data analyst.

Though up to five peoples DNA was found on the two articles, Bracamontes said using a supercomputer to allow her to identify Coleman as the major contributor. This method does not allow anyone to learn when or how the DNA, which is typically obtained through skin cells, was rubbed into the masks.

The trial resumes at 10 a.m. today in courtroom three before Judge Marc F. Lovecchio.

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Defense presents witnesses on day 3 of trial | News, Sports, Jobs - Williamsport Sun-Gazette

Skin Stem Cells Comments Off on Defense presents witnesses on day 3 of trial | News, Sports, Jobs – Williamsport Sun-Gazette | February 13th, 2020

Liposuction is a surgical procedure to remove extra fat from your body. It started in the 1980s and has become one of the most popular plastic surgeries in the US. An estimated 258,000 Americans got it in 2018.

Today, you can expect to pay around $3,500 for liposuction and most health insurance plans won't cover the cost. But if you're willing to pay the price, liposuction is a relatively safe and quick procedure that can help you shed fat that diet and exercise can't.

Here's what you need to know about how liposuction works and why it's not a weight-loss tool.

Liposuction is a 1-to2-hour-long procedure where fat cells are permanently removed from your body, usually for cosmetic reasons. People who get liposuction don't do it to lose large amounts of weight but rather to help sculpt the shape of their body.

Some of the most common places to have fat removed are the belly, thighs, buttocks, arms, back, the upper neck just under the chin, and jawline/jowls.

Depending on where you're getting the procedure, doctors will either provide a local anesthetic to numb the area of operation or they will give you a general anesthetic so you're unconscious during the procedure.

Then, surgeons will often inject into the area of operation a solution containing a mix of saline solution, a numbing medicine, and medicine the decreases bleeding. This is to help the skin and fat separate from important structures like muscles and blood vessels so they aren't damaged during the suctioning process.

After that, the surgeon inserts a long metal instrument called a cannula under your skin. The cannula then vacuums out your fat. During this process, surgeons may also use a smaller microcannula to remove fat in nearby areas to achieve a more natural, smoother contour.

Once the fat is removed through liposuction it can be discarded or it can be injected back into your body to enhance features like breasts, buttocks, or face. Or, more recently, in the last decade or so, liposuction has also been used to retrieve stem cells a type of cell that can form other specialized cells in the body for laboratory research.

After liposuction, your surgeon will likely recommend you wear a temporary band or brace over the area of operation to help the skin heal. The band or brace also helps prevent fluid from building up in the area of operation where the fat was removed, between the skin and deeper structures like muscles and blood vessels.

Whether you are awake or asleep during liposuction, you shouldn't feel any pain during the procedure, says Marco A. Pelosi II, MD, a cosmetic surgeon with experience performing liposuction procedures. The recovery, also, should be a relatively mild process.

After getting liposuction, you will feel soreness similar to a muscle ache. "The level of this soreness is typically a 2 or 3 out of 10 for a few weeks," says Pelosi, adding that you should be able to go back to work in 2 to 3 days.

Ongoing pain near the area where the cannula was inserted is a risk of liposuction, and if the pain grows or pain killers don't help, you should tell your surgeon.

According to the Cleveland Clinic, you should not use liposuction as a weight loss alternative. It recommends that if you want to lose weight, you should first try diet and exercise, then use liposuction to take care of more stubborn areas like the chin or belly fat.

Moreover, research shows that people who keep up other weight loss practices like a healthy diet and exercise will see better results after liposuction and keep fat from returning to a particular area.

This is because while liposuction permanently removes fat cells from your body, there is nothing to stop the remaining fat cells from getting bigger if you gain more weight.

There are some important safety tips to look for when choosing a liposuction provider.

First, look for a facility that meets national safety requirements. You can verify if a facility is accredited on the American Society of Plastic Surgeons' website here.

Pelosi says that doctors should also do blood work testing and medical clearances before a liposuction procedure to ensure your safety. These tests are to make sure you can safely undergo general anesthesia without complication. If, for example, you have an infection or are pregnant, you may not qualify for the surgery.

Last, but not least, is to look for a surgeon who is board-certified in performing these types of procedures and also has extensive experience with liposuction procedures so you know that they are well versed in the technique. To find out more about a practitioner's experience with liposuction, you can check the American Society of Plastic Surgeons' website.

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What is liposuction? How the procedure works and how painful it is - Insider - INSIDER

Skin Stem Cells Comments Off on What is liposuction? How the procedure works and how painful it is – Insider – INSIDER | February 13th, 2020

Penn State researchers have received a $2.8 million grant to investigate 3D bioprinting tissue for facial reconstructions, according to a Penn State news release.

The grant, from the National Institutes of Healths National Institute of Dental and Craniofacial Research, funds five years of research exploring methods for bioprinting face, mouth and skull tissue directly into patients during surgery, with the ultimate goal of developing a bioprinting technology, according to the release.

Craniomaxillofacial reconstruction currently presents challenges for doctors because it requires precisely stacking several different types of tissue. Penn States researchers hope to solve this problem by bioprinting the tissue directly into the subject, according to the release. Researchers will also be investigating the use of stem cells, biomaterials and differentiation factors in this process.

The team of researchers that received the grant includes professors of plastic surgery, biomedical engineering, and orthopedics and rehabilitation.

The researchers plan to investigate printing each type of tissue necessary for craniomaxillofacial reconstruction bone, fat and skin tissue individually, then study composite tissues that include all three of these layers. They hope that this will help them better understand how vascularization occurs in each type of tissue.

Ultimately, researchers hope to learn how different types of tissue interact and how bioprinting tissue directly into subjects will affect the facial reconstruction process.

If you're interested in submitting a Letter to the Editor, click here.

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Penn State receives grant to study bioprinting tissue for facial reconstructions - The Daily Collegian Online

Skin Stem Cells Comments Off on Penn State receives grant to study bioprinting tissue for facial reconstructions – The Daily Collegian Online | February 13th, 2020

The market analysis and insights included in the Cosmetic Skin Care market report presents key statistics on the market status of global and regional manufacturers and is an essential source of guidance which provides right direction to the companies and individuals interested in the industry. To prosper in this competitive market place, businesses are highly benefited if they adopt innovative solutions such as this Cosmetic Skin Care market research report. This wide-ranging market research report acts as a backbone for the success of business in any sector. The market drivers and restraints have been explained in the report with the use of SWOT analysis.

Global cosmetic skin care marketis set to witness a substantial CAGR of 5.5% in the forecast period of 2019- 2026. The report contains data of the base year 2018 and historic year 2017. Increasing self-consciousness among population and rising demand for anti- aging skin care products are the factor for the market growth.

Global Cosmetic Skin Care Market By Product (Anti-Aging Cosmetic Products, Skin Whitening Cosmetic Products, Sensitive Skin Care Products, Anti-Acne Products, Dry Skin Care Products, Warts Removal Products, Infant Skin Care Products, Anti-Scars Solution Products, Mole Removal Products, Multi Utility Products), Application (Flakiness Reduction, Stem Cells Protection against UV, Rehydrate the skins surface, Minimize wrinkles, Increase the viscosity of Aqueous, Others), Gender (Men, Women), Distribution Channel (Online, Departmental Stores and Convenience Stores, Pharmacies, Supermarket, Others), Geography (North America, Europe, Asia-Pacific, South America, Middle East and Africa) Industry Trends and Forecast to 2026 ;

Complete report on Global Cosmetic Skin Care Market Research Report 2019-2026 spread across 350 Pages, profiling Top companies and supports with tables and figures

Market Definition: Global Cosmetic Skin Care Market

Cosmetic skin care is a variety of products which are used to improve the skins appearance and alleviate skin conditions. It consists different products such as anti- aging cosmetic products, sensitive skin care products, anti- scar solution products, warts removal products, infant skin care products and other. They contain various ingredients which are beneficial for the skin such as phytochemicals, vitamins, essential oils, and other. Their main function is to make the skin healthy and repair the skin damages.

Key Questions Answered in Global Cosmetic Skin Care Market Report:-

Our Report offers:-

Top Key Players:

Market Drivers:

Market Restraints:

Key Developments in the Market:

Customize report of Global Cosmetic Skin Care Market as per customers requirement also available.

Market Segmentations:

Global Cosmetic Skin Care Market is segmented on the basis of

Market Segmentations in Details:

By Product

By Application

By Gender

By Distribution Channel

By Geography

North America

Europe

Asia-Pacific

South America

Middle East & Africa

Competitive Analysis: Global Cosmetic Skin Care Market

Global cosmetic skin care market is highly fragmented and the major players have used various strategies such as new product launches, expansions, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The report includes market shares of cosmetic skin care market for Global, Europe, North America, Asia-Pacific, South America and Middle East & Africa.

About Data Bridge Market Research:

Data Bridge Market Researchset forth itself as an unconventional and neoteric Market research and consulting firm with unparalleled level of resilience and integrated approaches. We are determined to unearth the best market opportunities and foster efficient information for your business to thrive in the market. Data Bridge endeavors to provide appropriate solutions to the complex business challenges and initiates an effortless decision-making process.

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COSMETIC SKIN CARE MARKET ENHANCEMENT AND ITS GROWTH PROSPECTS FORECAST 2019 TO 2026 - Reporting 99

Skin Stem Cells Comments Off on COSMETIC SKIN CARE MARKET ENHANCEMENT AND ITS GROWTH PROSPECTS FORECAST 2019 TO 2026 – Reporting 99 | February 13th, 2020

Cardiac rhythm management refers to a process of monitoring functioning of the heart through devices. Cardiac rhythm management devices are used to provide therapeutic solutions to patients suffering from cardiac disorders such as cardiac arrhythmias, heart failure, and cardiac arrests. Cardiac disorders lead to irregular heartbeat. Technological advancements and rise in the number of deaths due to increasing incidences of heart diseases and increasing aging population are some of the major factors driving the cardiac rhythm management market. Heart disease is one of the primary causes of death in the U. S. Excess of alcohol consumption; smoking, high cholesterol levels, and obesity are some of the major causes of heart diseases. Cardiac rhythm management is conducted through two major devices: implantable cardiac rhythm devices and pacemakers. Implantable cardiac rhythm devices treat patients with an improper heartbeat. Based on the device, the cardiac rhythm management market can be segmented into defibrillators, pacemakers, cardiac resynchronization therapy devices, implantable defibrillators, and external defibrillators. Pacemakers are used to treat patients with a slow heartbeat. Based on the end user, the cardiac rhythm management market can be segmented into hospitals, home/ambulatory, and others.

North America has the largest market for cardiac rhythm management due to improved healthcare infrastructure, government initiatives, rise in incidences of cardiac disorders, growing number of deaths due to cardiovascular diseases,and increasing healthcare expenditure in the region. The North America market for cardiac rhythm management is followed by Europe. Asia is expected to witness high growth rate in the cardiac rhythm management market in the next few years due to increasing incidences of cardiovascular diseases, growing disposable income, rise in awareness regarding heart disorders and relevant treatments, and improving healthcare infrastructure in the region.

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Increasing the prevalence of cardiovascular diseases, technological advancements, rise in life expectancy, increasing awareness regarding cardiac disorders, and government initiatives are some of the major factors that are expected to drive the market for cardiac rhythm management. In addition, factors such as a rise in disposable income, increasing aging population, and high cost associated with heart disease treatment are expected to drive the market for cardiac rhythm management. However, economic downturn, reimbursement issues, the importance of biologics and stem cells, and inappropriate use of the devices are some of the factors restraining the growth of the global cardiac rhythm management market.

Growing population and economies in the developing countries such as India and China are expected to drive the growth of the cardiac rhythm management market in Asia. In addition,factors such as innovations along with technological advancements such as miniaturization, introduction of MRI pacemakers, biocompatible materials and durable batteries, and continuous rise in aging population and increasing cardiovascular diseases such as arrhythmias, stroke, and high blood pressure are expected to create new opportunities for the global cardiac rhythm management market. An increasing number of mergers and acquisitions, rise in the number of collaborations and partnerships, and new product launches are some of the latest trends in the global cardiac rhythm management market.

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Some of the major companies operating in the global cardiac rhythm management market are Medtronic, Abbott Laboratories, Boston Scientific, St. Jude Medical, Altera, and Sorin. Other companies with significant presence in the global cardiac rhythm management market include

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Cardiac Rhythm Management Market to Witness Rapid Increase in Consumption During 2015 2021 - Lake Shore Gazette

Cardiac Stem Cells Comments Off on Cardiac Rhythm Management Market to Witness Rapid Increase in Consumption During 2015 2021 – Lake Shore Gazette | February 13th, 2020

Motor neuron disease is a degenerative condition which destroys the nerve cells (motor neurons) in the brain and spinal cord, which control movement, speech, swallowing and breathing. The most common type of motor neuron disease is amyotrophic lateral sclerosis (ALS), which affects around 5,000 people in the UK at any one time.A new study found that in this disease, the motor neurons in the brain and spinal cord become sick and die when a protein, called TDP-43, misfolds and accumulates in the wrong place within the motor neurons. Conversely, when this happens in a type of cell that supports motor neurons, called astrocytes, these cells appear comparatively resistant and survive.

When these two types of cells are close together, the more-resistant astrocytes are able to protect motor neurons from the misfolded protein. This rescue-mechanism helps the motor neurons, which are needed to control muscles, live longer.

The role astrocytes have played in dealing with toxic forms of TDP-43 in motor neurons has not been previously well documented in motor neuron disease. Its exciting that weve now found that they may play an important protective role in the early-stages of this disease, explains Phillip Smethurst, lead author. This has huge therapeutic potential finding ways to harness the protective properties of astrocytes could pave the way to new treatments. This could prolong their rescue function or find a way to mimic their behavior in motor neurons so that they can protect themselves from the toxic protein.

This research also established a new model for studying motor neuron disease. This new method more closely resembles the disease in patients as it uses healthy human stem cells, derived from skin cells, and spinal cord tissue samples donated by patients with motor neuron disease, collected post-mortem.

It is thanks to the selfless donations from people with motor neuron disease, that we were able to study the interplay between motor neurons and astrocytes in conditions that closely resemble what happens in humans. These human cell models are a powerful tool for further studies of motor neuron disease and in the hunt for effective therapies. explains Katie Sidle, co-senior author.

For the first time, we have been able to create a model of sporadic motor neuron disease by essentially transferring the toxic TDP-43 protein from post-mortem tissue into healthy human stem cell-derived motor neurons and astrocytes in order to understand how each cell type responds to this insult, both in isolation and when mixed together. The insights made in this work are testament to the power of creative collaboration and interdisciplinarity. It is through many years working together as a group of clinicians, pathologists, stem cell biologists, protein biochemists and other experts, and with a joint aim of increasing knowledge about motor neuron disease (to ultimately help find a cure), that these results have been possible, says Rickie Patani, co-senior author.ReferenceSmethurst et al. (2020) Distinct responses of neurons and astrocytes to TDP-43 proteinopathy in amyotrophic lateral sclerosis. Brain. DOI: https://doi.org/10.1093/brain/awz419

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

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Astrocytes Show Protective Role in Early-stage ALS - Technology Networks

Spinal Cord Stem Cells Comments Off on Astrocytes Show Protective Role in Early-stage ALS – Technology Networks | February 13th, 2020

10 February 2020

A study, published in Cell Reports, investigating when and how human stem cells develop into egg and sperm cells could one day help generate lab-grown gametes to treat infertility.

Human pluripotent stem cells can evolve into germ cells, which are the precursor cells for gamete development. By growing these human germ cells in vitro, the theory is that gametes engineered in a laboratory setting could someday be used, instead of natural eggs and sperm, in IVF treatment.

The research conducted within the Eli and Edythe Broad Centre of Regenerative Medicine and Stem Cell Research at University of California, Los Angeles (UCLA) provides great hope for those who are unable to produce gametes naturally,including thosewhose fertility has been affected by injury, illness or medical treatment.

'With donated eggs and sperm, the child is not genetically related to one or both parents. To treat patients who want a child who is genetically related, we need to understand how to make germ cells from stem cells, and then how to coax those germ cells into eggs or sperm'Dr Amander Clark, lead author of the study at UCLA, explained.

'Right now, if your body doesn't make germ cells, then there's no option for having a child that's biologically related to you. What we want to do is use stem cells to be able to generate germ cells outside the human body so that this kind of infertility can be overcome.'

In previous studies, scientists have been able to grow similarinduced pluripotent stem calls (iPS cells), and develop them into human skin cells and blood cells. The researchers, in collaboration with Massachusetts Institute of Technology, analysed the hundreds of thousands of genes active when both human embryonic stem cells and iPS cells transition to germ cells.

The data obtained allowed the researchers to firstly formulate when the germ cells are likely to form, which was between 24-48 hours after starting differentiation, and secondly which lineages of the differentiating stem cells give rise to the germ cells.

They also found that the activation and manifestation of germ cells was identical when developed from embryonic stem cells and iPS cells. This information was essential as they needed to ensure that the in vitro environment they had created was mimicking the molecular signals of the testis and ovaries to give hope for successful sperm and egg cell development.

Dr Clark stated: 'This tells us that the approach we're using to begin the process of making germ cells is on the right track. Now we're poised to take the next step of combining these cells with ovary or testis cells.'

Although current research is far from generating gametes, the end goal is that one day scientists are able to use a patient's skin cells to form stem cells, which can be programmed into egg or sperm cells to be used in fertility treatment.

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Lab-grown eggs and sperm a step closer - BioNews

Skin Stem Cells Comments Off on Lab-grown eggs and sperm a step closer – BioNews | February 11th, 2020

Photo: Yulia Gorbachenko

BEST ACNE-REDUCING FACIALRejuran Healer+ Laser Peel$737 for 60 minutes, Priv ClinicAt the heart of this facial is polynucleotide, a biopolymer molecule highly compatible with the human body. Delivered into the skin via a series of micro injections, it reportedly helps repair damaged skin cells, boost collagen synthesis, reduce sebum production and even out the skins moisture-oil balance. The miniscule punctures in the skin also trigger its natural wound-healing response, boosting cellular turnover. Some light swelling may appear post-treatment, but it goes away within 24 hours. Meanwhile, skin is visibly suppler, and looks smoother and healthier.

BEST ANTI-AGEING FACIALInstant Youth ProgrammeFrom $260 for 75 minutes, EstheClinicBehold the ultimate helping hand to counter the signs of mature skin. Each treatment is uniquely tailored to your specific skin type and needs, with subsequent sessions building on and enhancing the effects of prior treatments to maximise collagen production for firmer skin. By using the latest in aesthetic technology alongside EstheClinics specially selected cosmeceutical products, the signs of ageing are thus tackled from the inside out, with effects continuing to last up to four months after completing the programme.

BEST ANTI-BLEMISH FACIALTetra+ $398 per session, The Aesthetics Medical ClinicThis four-in-one treatment features a symphony of lasers with varying wavelengths to tackle multiple issues in just one sitting. A pigment wavelength breaks down melanin clusters to improve discoloration; a custom fractional laser refines texture; a superficial wavelength zaps clogged pores clean; and a long-pulse wavelength stimulates collagen production. Expect minimal to no downtimeand a smoother complexion in no time at all.

BEST BRIGHTENING FACIALRejuvenation Laser and Stem Cell Infusion$1,888 for five sessions, The Aesthetics Medical ClinicCombining two laser machinesQ Switch and yellow laserthat work in tandem to give you radiant, glowy skin, this also removes dirt, dead skin cells, oil and superficial hair, so skin is not only brightened, but also clearer and cleaner. The laser also helps to regulate oil production and reduce pigmentation, while the potent 80percent stem cell-derived serum delivers proteins, growth factors and cytokines intoskin to help boost regeneration and repair.

BEST CLEANSING FACIALJet Set$129 for 30 minutes, EPIONIdeal as a maintenance facial for time-strapped individuals, this express purifying solution rejuvenates weary skin in 30 minutes. A highpressure aqua jet peel gently sweeps away any build-up of dry and dead skin, before an ultrasonic deep cleanse purges pores of dirt, sebum and impurities. Jet technology is then used to infuse skin with potent actives with intense hydrating and brightening benefits.

Related article:BAZAAR Spa Awards 2020: Best Face Therapies To Transform And Pamper Your Skin

BEST DETOXIFYING FACIALVitamin C Infusion$288 for 45 minutes, Simply AestheticsBid adieu to skin woes such as open pores, blemishes, pigmentation and dullness with a super-potent dose of medical-grade vitamin C, which smooths and revitalises the skin. Besides getting rid of pore-clogging impurities that can make the skin appear dull or lacklustre, the facial also stimulates the dermal cells to actively produce collagen in order to regain that plump, fresh-faced radiance.

BEST EXPRESS FACIALIDS Electro Infusion (IEI)$280 for 45 minutes, IDS AestheticsGreat as a lunchtime facial, this uses a combination of electronic-magnetic pulses and LED light to brighten and firm skin. Designed to tackle various skin conditionspigmentation, fine lines, wrinkles, dryness, dullnessthis quickie facial is deemed a universal beauty enhancer and works its magic in less than an hour.

BEST EYE LIFT TREATMENTSygmaLift Eyes$670 for 60 minutes, Clifford AestheticsWhether its eyebags or dark circles that no concealer can hide, the root causes of your undereye issues are sussed out with a consultation in order to tailor an effective treatment. SygmaLift therapy, which utilises high-intensity focused ultrasound technology, is then applied to the under-eye area to contract the connective tissues deep within to tighten and smooth skin. The end resulta marked improvement in the appearance of under-eye bags, sagginess, discoloration and linestakes years off your face!

BEST HYDRATING FACIALHydraFacial$250 for 35 minutes, Dr Kevin Chua Medical & AestheticsThis all-in-one treatment starts off with a deep cleanse, and an exfoliating cocktail of salicylic and glycolic acids to break up pore-clogging impurities, allowing the HydraPeel Tip to essentially vacuum out sebum, product build-up, blackheads and dirt, before infusing skin with intensive serums to replenish hydration levels and provide antioxidant protection.

BEST LIFTING & FIRMING FACIALThermage FLX$5,350 for 90 minutes, Priv ClinicWant to reduce the look of fine lines, wrinkles, sagging skin and other signs of ageing, or simply delay their dreaded appearance? Promising just that is the Thermage FLX, which uses radio frequency to stimulate cell regeneration and collagen production. This newgen treatment is optimised for improved comfort and more controlled delivery, and the results from one session is said to last for months.

BEST PORE-REFINING FACIAL3D Deep Pore Cleansing Facial$588 for 90 minutes, Aesthetics Central ClinicFlawless skin can now be had with this signature treatment that utilises a patented device called 50 Micron Jet Technology, where high-pressure micro-jets of water gently push out the sebum and impurities trapped in pores. As the pores are being cleaned out, the machine delivers a serum, designed to lift and tighten skin while encouraging microcirculation, deep into the skin.

BEST REJUVENATING FACIALPicoWay RESOLVE $650 for 30 minutes, Dr Kevin Chua Medical & AestheticsSo named for the technology where laser pulses are delivered in picosecondsa unit of measurement that refers to one trillionth of a seconda PicoWay facial sends small bursts of intense laser energy deep into the skin to stimulate its natural healing abilities. The short pulsations mean that less heat is emitted during the procedure, so you neednt worry about post-treatment burns. Benefits of the treatment, which is suitable for most skin types, include plumper, suppler skin with improved tone and texture.

Related article:Spa Awards 2020 Best Rejuvenating Facial: PicoWay RESOLVE

BEST RESURFACING FACIALPico Fractional Laser Treatment$300 for 60 minutes, Calvin Chan Aesthetic & Laser ClinicVia short but intense pulses of laser energy delivered deep into the dermis, the skin is transformed from the inside out as new collagen and elastin is produced to significantly improve the appearance of pitted acne scars, pigmentation and wrinkles. And if youre worried about downtime, dont. The surface of the skin is left intact while the deep tissue heals, which means theres no recovery time involved.

BEST SHAPING & TIGHTENING FACIALBiologique Recherche Remodeling Face $380 for 90 minutes, Freia AestheticsThis kicks off with a 60-minute booster customised to your skins needs, followed by a proprietary massage that promotes blood flow and stimulates the lymph nodes for a detoxifying effect. The Remodelling Face machine then uses a bespoke blend of electric, galvanic and high-frequency currents to enhance the benefits of the preceding steps, and deliver product actives deeper and more efficiently into skin for a supreme lifting, tightening and plumping effect.

BEST SOOTHING FACIALSeriously Soothing $209 for 90 minutes, EPIONLiving up to its name, this hydrates and calms thirsty skin with a side of sensitivity. Ultrasonic energy is first used to give skin a deep cleanse. This is followed by a dose of much-needed hyaluronic acid and the application of a soothing face mask. The final step: LED red light therapy to help stimulate collagen production and reduce redness or inflammation.

Related article:Cindy Crawford Shows How She Stays Fabulous At Every Age In Our February Issue

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Spa Awards 2020: Best Specialised Solutions Tackle Every Skin Concern - Harper's Bazaar Singapore

Skin Stem Cells Comments Off on Spa Awards 2020: Best Specialised Solutions Tackle Every Skin Concern – Harper’s Bazaar Singapore | February 11th, 2020