Every year, BioSpace analyzes the biotech industry, looking for the hot new biotech startups to watch. We then produce the NextGen Bio Class of, twenty companies ranked based on several categories, including Finance, Collaborations, Pipeline, and Innovation. The companies were typically launched no more than 18 months before the list was created.

We thought it would be insightful to look back at our previous lists to see where some of those companies are today. Heres a look at the top three companies from the Top 20 Life Science Startups to Watch in 2018.

#1. BlueRock Therapeutics. Founded in 2016, BlueRock was #1 on our list of companies to watch in 2018. With facilities in Ontario, Canada; Cambridge, Massachusetts; and New York, New York, BlueRock launched in December 2016 with a $225 million Series A financing led by Bayer AG and Versant Ventures. The company focuses on cell therapies to regenerate heart muscle in patients who have had a heart attack or chronic heart failure, as well as therapies for patients with Parkinsons disease.

In October 2017, BlueRock and Seattle-based Universal Cells entered into a collaboration and license deal to create induced pluripotent stem (iPS) cell lines that can be used in the manufacture of allogeneic cellular therapies. Shortly afterwards, the company established its corporate headquarters in Cambridge, and in April 2018, established a research-and-development hub in New York City, as well as formalizing a sponsored research collaboration with the Center for Stem Cell Biology at Memorial Sloan Kettering (MSK) Cancer Center. The collaboration focuses on translating Ketterings expertise in creating multiple types of authentic neural cells from stem cells to address diseases of the central and peripheral nervous system. BlueRock also received $1 million from the State of New York and Empire State Development under its economic development initiatives program.

In April 2019, BlueRock partnered with Editas Medicine (which was on BioSpaces NextGen Bio Class of 2015 list) to combine their genome editing and cell therapy technologies to focus on novel engineered cell medicines. Part of the deal was to collaborate on creating novel, allogeneic pluripotent cell lines using a combination of Editas CRISPR genome editing technology and BlueRocks iPSC platform.

And finally, in August 2019, Bayer AG acquired BlueRock for the remaining stake in the company for about $240 million in cash and an additional $360 million in pre-defined development milestones.

#2. Prelude Fertility. Prelude Fertility is a bit of an outlier from the typical BioSpace NextGen company, because it isnt quite a biopharma company. It is a life sciences company whose business model is aimed at in vitro fertilization and egg freezing. It was founded with a $200 million investment by entrepreneur Martin Varsavsky. The investment was in the largest in vitro fertilization clinic in the Southeast, Reproductive Biology Associates of Atlanta, and its affiliate, My Egg Bank, the largest frozen donor egg bank in the U.S.

Since then it has expanded in various parts of the country, including adding San Francisco-based Pacific Fertility Center (PFC) to its network in September 25, 2017; partnering with Houston Fertility Institute and acquiring Vivere Health; partnering with the Advanced Fertility Center of Chicago; and in October 2018, partnered with NYU Langone Health.

In March 2019, Prelude merged with Inception Fertility to establish the Prelude Network as the fastest-growing network of fertility clinics and largest provider of comprehensive fertility services in the U.S. Inception is acting as the parent company, with the Prelude Network, both having board representatives from the previous organizations.

#3. Relay Therapeutics. Ranking #3 on our list for 2018, Relay Therapeutics launched in September 2016 with a $57 million Series A financing led by Third Rock Ventures with participation form D.E. Shaw Research. On December 14, 2017, it closed on a Series B round worth $63 million, led by BVF Partners, with new investors GV (formerly Google Ventures), Casdin Capital, EcoR1 Capital and Section 32.

The company focuses on the relationship between protein motion and function. It merges computational power with structural biology, biophysics, chemistry and biology. In December 2018, the company completed a $400 million Series C financing. It was led by the SoftBank Vision fund and included additional new investors, Foresite Capital, Perceptive Advisors and Tavistock Group. Existing investors also participated.

The company announced at the time it planned to use the funds to accelerate the implementation of its long-term strategy, expanding its discovery efforts, advancing existing programs into the clinic and improving its platform.

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Where Are They Now? Top 3 Biotech Startups From NextGen Bio Class of 2018 - BioSpace

IPS Cell Therapy Comments Off on Where Are They Now? Top 3 Biotech Startups From NextGen Bio Class of 2018 – BioSpace | January 7th, 2020

In theglobalstem cells marketa sizeable proportion of companies are trying to garner investments from organizations based overseas. This is one of the strategies leveraged by them to grow their market share. Further, they are also forging partnerships with pharmaceutical organizations to up revenues.

In addition, companies in the global stem cells market are pouring money into expansion through multidisciplinary and multi-sector collaboration for large scale production of high quality pluripotent and differentiated cells. The market, at present, is characterized by a diverse product portfolio, which is expected to up competition, and eventually growth in the market.

Some of the key players operating in the global stem cells market are STEMCELL Technologies Inc., Astellas Pharma Inc., Cellular Engineering Technologies Inc., BioTime Inc., Takara Bio Inc., U.S. Stem Cell, Inc., BrainStorm Cell Therapeutics Inc., Cytori Therapeutics, Inc., Osiris Therapeutics, Inc., and Caladrius Biosciences, Inc.

Request PDF Sample of Stem Cells Market Report @https://www.transparencymarketresearch.com/sample/sample.php?flag=S&rep_id=132

As per a report by Transparency Market Research, the global market for stem cells is expected to register a healthy CAGR of 13.8% during the period from 2017 to 2025 to become worth US$270.5 bn by 2025.

Depending upon the type of products, the global stem cell market can be divided into adult stem cells, human embryonic stem cells, induced pluripotent stem cells, etc. Of them, the segment of adult stem cells accounts for a leading share in the market. This is because of their ability to generate trillions of specialized cells which may lower the risks of rejection and repair tissue damage.

Depending upon geography, the key segments of the global stem cells market are North America, Latin America, Europe, Asia Pacific, and the Middle East and Africa. At present, North America dominates the market because of the substantial investments in the field, impressive economic growth, rising instances of target chronic diseases, and technological progress. As per the TMR report, the market in North America will likely retain its dominant share in the near future to become worth US$167.33 bn by 2025.

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Investments in Research Drives Market

Constant thrust on research to broaden the utility scope of associated products is at the forefront of driving growth in the global stem cells market. Such research projects have generated various possibilities of different clinical applications of these cells, to usher in new treatments for diseases.Since cellular therapies are considered the next major step in transforming healthcare, companies are expanding their cellular therapy portfolio to include a range of ailments such as Parkinsons disease, type 1 diabetes, spinal cord injury, Alzheimers disease, etc.

The growing prevalence of chronic diseases and increasing investments of pharmaceutical and biopharmaceutical companies in stem cell research are the key driving factors for the stem cells therapeutics market. The growing number of stem cell donors, improved stem cell banking facilities, and increasing research and development are other crucial factors serving to propel the market, explains the lead analyst of the report.

This post was originally published on Food and Beverage Herald

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Stem Cells Market Segmentation and Analysis Report, 2025 - Food & Beverage Herald

Spinal Cord Stem Cells Comments Off on Stem Cells Market Segmentation and Analysis Report, 2025 – Food & Beverage Herald | January 7th, 2020

Funding to Support Ongoing Advancement of siFi2, Lead Candidate from Companys First-of-its-Kind Platform for Precisely Controlling Core Cell Migration Mechanisms

NEW YORK, Jan. 07, 2020 (GLOBE NEWSWIRE) -- MicroCures, a biopharmaceutical company developing novel therapeutics that harness the bodys innate regenerative mechanisms to accelerate tissue repair, today announced that it has been awarded a Phase 2 Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH). The two-year, $1.5 million award will support ongoing development of the companys lead product candidate, siFi2. siFi2, a small interfering RNA (siRNA) therapeutic that can be applied topically, is designed to enhance recovery after trauma. This Phase 2 grant continues the companys successful Phase 1 SBIR contract which demonstrated significantly improved repair of burn wounds following treatment with siFi2 in animal models.

MicroCures technology is based on foundational scientific research at Albert Einstein College of Medicine regarding the fundamental role that cell movement plays as a driver of the bodys innate capacity to repair tissue, nerves, and organs. The company has shown that complex and dynamic networks of microtubules within cells crucially control cell migration, and that this cell movement can be reliably modulated to achieve a range of therapeutic benefits. Based on these findings, the company has established a first-of-its-kind proprietary platform to create siRNA-based therapeutics capable of precisely controlling the speed and direction of cell movement by selectively silencing microtubule regulatory proteins (MRPs).

The company has developed a broad pipeline of therapeutic programs with an initial focus in the area of tissue, nerve and organ repair. Unlike regenerative medicine approaches that rely upon engineered materials or systemic growth factor/stem cell therapeutics, MicroCures technology directs and enhances the bodys inherent healing processes through local, temporary modulation of cell motility. The companys lead drug candidate, siFi2, is a topical siRNA-based treatment designed to silence the activity of Fidgetin-Like 2 (FL2), a fundamental MRP, within an area of wounded tissue. In doing so, the therapy temporarily triggers accelerated movement of cells essential for repair into an injury area. Importantly, based on its topical administration, siFi2 can be applied early in the treatment process as a supplement to current standard of care.

We are grateful for NIHs continued support of our work through this multi-year Phase 2 SBIR grant. This non-dilutive financial support allows us to continue building a robust portfolio of preclinical data in animal models that demonstrate the therapeutic potential of siFi2 to significantly improve and accelerate healing of burn wounds, said David Sharp, Ph.D., co-founder and chief science officer of MicroCures. This funding will help advance our research as we work towards first-in-human clinical trial in 2020.

The initial Phase 1 SBIR grant from NIH funded preclinical research by MicroCures which demonstrated that treatment with siFi2 accelerated re-epithelization, improved collagen deposit and maturation, and improved quality of healing in a porcine full thickness burn model. Specific findings showed that following eight weeks of treatment, 39% of siFi2-treated wounds were closed as compared to only 11% for control subjects and 0% for placebo. Additionally, siFi2-treated subjects demonstrated a significantly improved rate of healing as measured by epithelial surface measurements as compared to placebo (p = 0.0106) and control (p = 0.0012).

About MicroCures

MicroCures develops biopharmaceuticals that harness innate cellular mechanisms within the body to accelerate and improve recovery after traumatic injury. MicroCures has developed a first-of-its-kind therapeutic platform that precisely controls the rate and direction of cell migration, offering the potential to deliver powerful therapeutic benefits for a variety of large and underserved medical applications.

MicroCures has developed a broad pipeline of novel therapeutic programs with an initial focus in the area of tissue, nerve and organ repair. The companys lead therapeutic candidate, siFi2, targets excisional wound healing, a multi-billion dollar market inadequately served by current treatments. Additional applications for the companys cell migration accelerator technology include dermal burn repair, corneal burn repair, cavernous nerve regeneration, spinal cord regeneration, and cardiac tissue repair. Cell migration decelerator applications include combatting cancer metastases and fibrosis. The company protects its unique platform and proprietary therapeutic programs with a robust intellectual property portfolio including eight issued or allowed patents, as well as eight pending patent applications.

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For more information please visit: http://www.microcures.com

Disclaimer: The SBIR Grant (2R44AR070696-02A1) is supported by the NIHs National Institute of Arthritis and Musculoskeletal and Skin Diseases. The content of this press release is solely the responsibility of MicroCures and does not necessarily represent the official views of the NIH.

Contact:

Vida Strategic Partners (On behalf of MicroCures)

Stephanie Diaz (investors)415-675-7401sdiaz@vidasp.com

Tim Brons (media)415-675-7402tbrons@vidasp.com

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MicroCures Awarded $1.5M SBIR Grant To Support Development of Novel Therapeutic Platform for Accelerated Tissue Repair - Yahoo Finance

Cardiac Stem Cells Comments Off on MicroCures Awarded $1.5M SBIR Grant To Support Development of Novel Therapeutic Platform for Accelerated Tissue Repair – Yahoo Finance | January 7th, 2020

NEW YORK, Jan. 07, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, announced today that Chaim Lebovits, President and Chief Executive Officer, will provide a corporate overview at the 2020 Biotech Showcase, being held on January 13-15, 2020 at the Hilton San Francisco Union Square in San Francisco, California.

Mr. Lebovits will also present at the 3rd Annual Neuroscience Innovation Forum, taking place on January 12, 2020, at the Marines Memorial Club in San Francisco. Additionally, Ralph Kern M.D., MHSc, BrainStorms Chief Operating Officer and Chief Medical Officer, will participate on aRare & Orphan Diseases Panel.

Meetings

BrainStorms senior management will also be hosting institutional investor and partnering meetings at the 2020 Biotech Showcase conference (https://goo.gl/SGFm62). Please use the Investor contact information provided below to schedule a meeting.

About NurOwn

NurOwn (autologous MSC-NTF cells) represent a promising investigational approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. NurOwn is currently being evaluated in a Phase 3 ALS randomized placebo-controlled trial and in a Phase 2 open-label multicenter trial in Progressive MS.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. For more information, visit BrainStorm's website at http://www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could causeBrainStorm Cell Therapeutics Inc.'sactual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorms need to raise additional capital, BrainStorms ability to continue as a going concern, regulatory approval of BrainStorms NurOwn treatment candidate, the success of BrainStorms product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorms NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorms ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorms ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available athttp://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

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BrainStorm Cell Therapeutics to Present at the 2020 Biotech Showcase and 3rd Annual Neuroscience Innovation Forum at JPM Week - Yahoo Finance

Bone Marrow Stem Cells Comments Off on BrainStorm Cell Therapeutics to Present at the 2020 Biotech Showcase and 3rd Annual Neuroscience Innovation Forum at JPM Week – Yahoo Finance | January 7th, 2020

Cynata Therapeutics (CYP) has received a research and development tax incentive refund of $1,891,795 for the 2018-2019 financial year.

This tax incentive refund increases the company's cash position which stood at $9.2 million at the end of the September quarter.

It also enables further resources to be invested towards Cynata's phase 2 clinical trial programs for the critical limb ischemia (CLI) (reduced blood flow) and osteoarthritis products.

This will be alongside the anticipated phase 2 trial for CYP-001 in graft-versus-host disease which will be conducted by Fujifilm.

CLI is an advanced stage of peripheral artery disease which is the narrowing of the arteries in the limbs, typically in the lower legs.

It results from severely impaired blood flow which can cause pain, tissue damage, and gangrene.

Around 25 per cent of CLI patients who are unable to undergo surgery to remove the affected area, often an amputation, will die within a year of diagnosis.

Cynata' Cymerus mesenchymal stem cells (MSCs) have been successfully tested in a mouse model of CLI.

Muscles on the ischaemic leg were injected with Cymerus MSCs or a control.

Over a four-week follow-up period, the return of blood flow was measured and in animals treated with Cymerus MSCs blood flow in the injured limb was significantly higher at every point compared to the control.

MSCs are an adult stem cell found in a wide range of human tissues including bone marrow, fat tissue and placenta.

They are multi-potent which means they can produce more than one type of cell, for example they can differentiate into cartilage cells, bone cells and fat cells.

MSCs have been shown to ease regeneration and effects on the immune system without relying on engraftment (when the transplanted cells start to grow and make healthy cells).

The research and development tax incentive is an important Australian Government program that encourages companies to engage in research and development benefiting Australia by providing a tax offset for eligible activities.

Cynata's share price is up a steady 4.82 per cent with shares trading for $1.20 apiece at 3:29 pm AEDT.

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Cynata Therapeutics (ASX:CYP) receives R&D tax incentive refund of more than $1.8M - The Market Herald

Bone Marrow Stem Cells Comments Off on Cynata Therapeutics (ASX:CYP) receives R&D tax incentive refund of more than $1.8M – The Market Herald | January 7th, 2020

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Phase 3 KEYNOTE-604 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 the first-line treatment of patients with extensive stage small cell lung cancer (ES-SCLC). In the study, treatment with KEYTRUDA in combination with chemotherapy (etoposide plus cisplatin or carboplatin) resulted in a statistically significant improvement in PFS compared to chemotherapy alone (HR=0.75 [95% CI, 0.61-0.91]), which was observed at a prior interim analysis. At the final analysis of the study, there was also an improvement in overall survival (OS) for patients treated with KEYTRUDA in combination with chemotherapy compared to chemotherapy alone; however, these OS results did not meet statistical significance per the pre-specified statistical plan (HR=0.80 [95% CI, 0.64-0.98]). The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies. Results will be presented at an upcoming medical meeting and discussed with regulatory authorities.

Results of KEYNOTE-604 demonstrated the potential of KEYTRUDA, in combination with chemotherapy, to improve outcomes for patients newly diagnosed with extensive stage small cell lung cancer, a highly aggressive malignancy, said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. We sincerely thank the patients and investigators for their participation in this study and are committed to helping patients who face difficult-to-treat types of lung cancer.

In addition to KEYTRUDAs five current indications in lung cancer, Merck is continuing to study KEYTRUDA across multiple settings and stages of lung cancer through a broad clinical program, which is comprised of more than 10,000 patients enrolled or expected to be enrolled across 20 Merck-sponsored clinical studies.

About KEYNOTE-604

KEYNOTE-604 is a randomized, double-blind, placebo-controlled Phase 3 trial (ClinicalTrials.gov, NCT03066778) investigating KEYTRUDA in combination with chemotherapy compared to chemotherapy alone in patients with newly diagnosed ES-SCLC. The dual primary endpoints were OS and PFS. Secondary endpoints included objective response rate (ORR), duration of response (DOR), safety and quality of life (QoL). The study enrolled 453 patients who were randomized to receive either:

About Lung Cancer

Lung cancer, which forms in the tissues of the lungs, usually within cells lining the air passages, is the leading cause of cancer death worldwide. Each year, more people die of lung cancer than die of colon and breast cancers combined. The two main types of lung cancer are non-small cell and small cell. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for about 85% of all cases. Small cell lung cancer (SCLC) accounts for about 10 to 15% of all lung cancers. The five-year survival rate for patients diagnosed in the U.S. with any stage of SCLC is estimated to be 6%.

About KEYTRUDA (pembrolizumab) Injection, 100mg

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 patients 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 one 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.

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 hypophysitis, thyroid disorders, and type 1 diabetes mellitus. 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 hypophysitis (including hypopituitarism and adrenal insufficiency), thyroid function (prior to and periodically during treatment), and hyperglycemia. For hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 and withhold or discontinue for Grade 3 or 4 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; 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%).

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%).

Adverse reactions occurring in patients with hepatocellular carcinoma (HCC) were generally similar to those in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of ascites (8% Grades 34) and immune-mediated hepatitis (2.9%). Laboratory abnormalities (Grades 34) that occurred at a higher incidence were elevated AST (20%), ALT (9%), and hyperbilirubinemia (10%).

Among the 50 patients with MCC enrolled in study KEYNOTE-017, adverse reactions occurring in patients with MCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy. Laboratory abnormalities (Grades 34) that occurred at a higher incidence were elevated AST (11%) and hyperglycemia (19%).

In KEYNOTE-426, when KEYTRUDA was administered in combination with axitinib, fatal adverse reactions occurred in 3.3% of 429 patients. Serious adverse reactions occurred in 40% of patients, the most frequent (1%) were hepatotoxicity (7%), diarrhea (4.2%), acute kidney injury (2.3%), dehydration (1%), and pneumonitis (1%). Permanent discontinuation due to an adverse reaction occurred in 31% of patients; KEYTRUDA only (13%), axitinib only (13%), and the combination (8%); the most common were hepatotoxicity (13%), diarrhea/colitis (1.9%), acute kidney injury (1.6%), and cerebrovascular accident (1.2%). The most common adverse reactions (20%) were diarrhea (56%), fatigue/asthenia (52%), hypertension (48%), hepatotoxicity (39%), hypothyroidism (35%), decreased appetite (30%), palmar-plantar erythrodysesthesia (28%), nausea (28%), stomatitis/mucosal inflammation (27%), dysphonia (25%), rash (25%), cough (21%), and constipation (21%).

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Merck's KEYTRUDA (pembrolizumab) in Combination with Chemotherapy Significantly Improved Progression-Free Survival Compared to Chemotherapy Alone as...

Skin Stem Cells Comments Off on Merck’s KEYTRUDA (pembrolizumab) in Combination with Chemotherapy Significantly Improved Progression-Free Survival Compared to Chemotherapy Alone as… | January 7th, 2020

The latest lifestyle, fashion and travel trends

A high-end bio-beauty boom is in full bloom thanks to a host of revolutionary brands set on changing the face of modern skincare. These are the five to know...

Hailing from the Napa Valley, where founder April Gargiulo spent two years researching and developing her Holy Grail skincare products using the same meticulous approach her family took to their fine wine business, Vintners Daughter champions just two products that promise dramatic, multi-correctional results using some of the worlds most active organic and foraged botanicals. The original Active Botanical Serum (175) is hailed as the face oils to end all face oils and is built around the brands signature Phyto Radiance Infusion. This process starts with consciously grown whole plants such as calendula and super green alfalfa, known in ancient times as the foods of life, which undergo a methodical three-week long extraction to glean every last drop of their nutritional benefits. Just five drops using the brands 30-second Push/Press Method of application promises to deliver visible radiance, brightness and unparalleled nourishment particularly when used in conjunction with its preparatory Active Treatment Essence (210) (goop.com).

The undisputed Queen of Green, Tata Harper is a pioneer of the farm-to-face beauty movement with all-natural formulations handcrafted in the brands laboratory in Vermont and bottles stamped with a code to trace how fresh your product is and who it was made by. The beauty editors favourite is going one step further with the launch of its Supernaturals 2.0 line of six products boasting 155 ultramodern green ingredients from 46 countries and of course, no synthetic chemicals. The Elixir Vitae Serum (391) alone boasts 34 new radical engineered ingredients from 25 countries, including kelp polymers from France developed to target cellular ageing. Other highlights from the range include the Concentrated Brightening Serum (257), which contains 24 ingredients to hydrate, 17 to reduce wrinkles, 15 to brighten and 13 to even skin tone, and the Boosted Contouring Serum (257), designed to lift, firm and restore youthful elasticity with a combination of Edelweiss stem cells and skin revitalising pomegranate. (tataharperskincare.com)

The brainchild of cosmetologist Anna Buonocore and naturalist Jeanette Thottrup, Seed To Skin believes that effective skincare is threefold. Firstly, that wild ingredients foraged from the land and sea used in conjunction with those sourced from its organic Tuscan farm are among the most potent nature has to offer. Secondly, that just like feeding your body skin requires a healthy, balanced diet and formulas that neither starve nor overload with any one element. Finally, that the most effective absorption relies on a precise mix of perfectly-sized molecules to ensure each ingredient is delivered exactly where it needs to go. As a result, its award-winning product line is loaded with game changers try The AlcheMist Super Active Serum Spray (145) to feed your skin a nutrient-rich drink whenever it needs a boost, or the Black Magic Detoxifying Oxygen Therapy Mask (119) which contains activated charcoal and volcanic clay for a one-stop facial in a jar (libertylondon.com).

(Wildsmith )

Inspired by the arboretums progressive approach to cultivation at Hampshires Heckfield Place and named after its mastermind William Walker Wildsmith, this ethical crafted-in-England skincare brand is designed for those who desire natural products but demand clinical results. Exclusive to Harrods beauty halls, the hero additions to its product line-up include the Platinum Booster (175) a powerful skin-firming treatment powered by encapsulated oxygen and moss cell cultures and a reviving, collagen-boosting Copper Peptide Cream and Serum Duo (150) which delivers a luminous finish to your complexion and comes in a compostable mycelium box (wildsmithskin.com; harrods.com).

After turning to flower arranging as a weekly dose of mindfulness, beauty entrepreneur Kelly S Chung endeavoured to harness the healing power of nature or Flower Therapy, as she has coined it in another form; and Femmue was born. Fusing K-beauty innovation with a clean beauty ethos and the cellular energy of plants, the camellia flower is at the heart of the range and renowned for its antioxidant and restorative qualities. The Divine Camlia Facial Oil (100) is the purest form with 99.8 per cent camellia seed oil, while other must-try products in the line include the bestselling Flower Infused Fine Mask (40) formulated with camellia petals, geranium oil and cactus extract and the lavender-loaded Brilliant Cleansing Oil (73) (net-a-porter.com).

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Super Naturals: the high-tech natural beauty brands changing the face of modern skincare - Evening Standard

Skin Stem Cells Comments Off on Super Naturals: the high-tech natural beauty brands changing the face of modern skincare – Evening Standard | January 6th, 2020

In high school Aaron Sandoval became obsessed with Deadpool, Marvels comic character who has accelerated healing and regenerative powers.

Sandoval has turned in his superhero cape for a lab coat in medicine by working with reparative methods for the human body. And now, hes received a national award that will allow him to do that.

Sandoval, a 21-year-old UF biology senior, was selected for the Marshall Scholarship, which gives students in the U.S. a chance to pursue their graduate studies in the United Kingdom, all expenses paid. He is the second Marshall scholar in UFs history, following Steven Robinette in 2009.

Sandoval was one of 46 students chosen out of over 1,000 applicants across the U.S.

The Marshall Scholarship Program was created in 1953 to thank the U.S. for helping the U.K. after World War II under the Marshall Plan, which was the U.S.s way of helping European economies after the devastation of the war, according to the programs website.

It still hasnt really sunk in yet, Sandoval said. Im happy to have won it.

Sandoval said in his two years at the University of Cambridge and Kings College London hell study biochemistry and focus on the transfer of stem cells from the lab to the patients so they can understand what cells are being used to help them.

Sandoval has collaborated with UF faculty members like Malcolm Maden, a professor in UFs Cancer and Genetics Research Institute. Sandoval and Maden worked in a lab with an African spiny mouse, to figure out how stem cells repair parts of the human body like skin tissue.

In 2012, Maden and his research team discovered the African spiny mouses ability to regenerate skin scar free. Maden wrote one of Sandovals letters of recommendation for his application for the scholarship.

Sandoval said if the mouses regeneration of skin cells could be translated to humans, then a humans wounds could completely heal rather than scar.

Sandoval didnt have the opportunity to do research in high school and wanted to learn more at the university level, so he decided to take Madens lab.

Maden said Sandovals uniqueness stems from his intelligence, drive and ability to interact with different kinds of people.

Hes behaved like a dynamic scientist, not like an undergrad, he said. Completely amazing, totally unique guy.

Sandoval said he feels fortunate to have won the award and to have so many people who helped him get to this point.

I couldnt have done it without the support of family, friends, mentors, he said. It took a whole village to win this thing.

Contact Emma McAvoy at[emailprotected]. Follow her on Twitter@EmmaMcAvoy1.

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UF student chosen for the Marshall Scholarship, will pursue Masters degrees in United Kingdom - The Independent Florida Alligator

Skin Stem Cells Comments Off on UF student chosen for the Marshall Scholarship, will pursue Masters degrees in United Kingdom – The Independent Florida Alligator | January 6th, 2020

Technavio has been monitoring the global amniotic membrane market since 2019 and the market is poised to grow by USD 1.48 billion during 2020-2024, progressing at a CAGR of more than 13% during the forecast period. Request a free sample report

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200106005080/en/

Technavio has announced its latest market research report titled global amniotic membrane market 2020-2024 (Graphic: Business Wire)

Read the 145-page report with TOC on "Amniotic Membrane Market Analysis Report by Geography (Asia, Europe, North America, and ROW), Type (Cryopreserved amniotic membrane and Dehydrated amniotic membrane), and the Segment Forecasts, 2020-2024".

https://www.technavio.com/report/amniotic-membrane-market-industry-analysis

The market is driven by the rising demand for biocompatible scaffolds. In addition, the rise in the development of new applications through research is anticipated to boost the growth of the amniotic membrane market.

The rising need for naturally derived materials in tissue scaffolding is increasing the demand for amniotic membranes. This is due to the specialized structure of amniotic membranes that exhibit high biological viability, making them ideal for creating bio-scaffolds. Moreover, the epithelial cells in amniotic membranes have the advantages of stem cells which provide a native environment of cell seeding. Bio-scaffolds are widely used in regenerative therapies for the treatment of bone, cartilage, skin, vascular tissues, and skeletal muscles. With growing geriatric population, the demand for such orthopaedic regenerative therapies is expected to increase significantly during the forecast period. This will have a positive impact on the demand for amniotic membranes.

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Major Five Amniotic Membrane Market Companies:

Celularity Inc.

Celularity Inc. operates its business through the Unified Business Segment. BIOVANCE is the key offering of the company. It offers a decellularized, dehydrated human amniotic membrane allograft that contains natural extracellular matrix (ECM) that helps in wound regeneration and tissue restoration.

Human Regenerative Technologies LLC

Human Regenerative Technologies LLC operates the business across segments such as Flowable and Membrane. HydraTek amniotic membrane products, is the key offering of the company. It includes thin and thick dehydrated amniotic membranes used in covering and protecting the recipient's tissue.

Integra LifeSciences Holdings Corp.

Integra LifeSciences Holdings Corp. operates its business across segments such as Codman Specialty Surgical, and Orthopedics and Tissue Technologies. The company offers a wide range of amniotic membrane products. Some of the key offerings include AmnioExcel Amniotic Allograft Membrane, BioDDryFlex Amniotic Tissue Membrane, BioDOptix Amniotic Extracellular Membrane, and Integra BioFix Amniotic Membrane Allograft.

Katena Products Inc.

Katena Products Inc. operates the business across segments such as Instruments, Biologics, Plugs, Lenses, Devices, and Blink Medical. Amniotic Membrane Surgical and Amniotic Membrane Clinic are some of the key offerings of the company.

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MiMedx Group Inc.

MiMedx Group Inc. operates the business in the Regenerative biomaterial products and bioimplants segment. The company offers a wide range of amniotic membrane products. AmnioFix, EpiFix, and EpiBurn are the key offerings of the company.

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Amniotic Membrane Type Outlook (Revenue, USD Billion, 2020 - 2024)

Amniotic Membrane Regional Outlook (Revenue, USD Billion, 2020 - 2024)

Technavios sample reports are free of charge and contain multiple sections of the report, such as the market size and forecast, drivers, challenges, trends, and more. Request a free sample report

Related Reports on Healthcare include:

Global Extracorporeal Membrane Oxygenation Machines Market Global extracorporeal membrane oxygenation machines market by geography (Asia, Europe, North America, and ROW) and modality (veno-venous and arterio-venous; and veno-arterial).

Global Duchenne Muscular Dystrophy (DMD) Therapeutics Market Global Duchenne muscular dystrophy (DMD) therapeutics market by type (biologics and small molecules) and geography (Asia, Europe, North America, and ROW).

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Global Amniotic Membrane Market 2020-2024 | Evolving Opportunities with Celularity Inc. and Human Regenerative Technologies LLC | Technavio - Yahoo...

Skin Stem Cells Comments Off on Global Amniotic Membrane Market 2020-2024 | Evolving Opportunities with Celularity Inc. and Human Regenerative Technologies LLC | Technavio – Yahoo… | January 6th, 2020

3 January 2020

Victoria Beckham aims to "create a brand of the future" with Victoria Beckham Beauty.

Victoria Beckham

The former Spice Girl launched her eponymous beauty brand last year, later expanding her label to include skincare, and the 45-year-old fashion designer says her intention was to create products that are sustainable and not made from toxic formulas, whilst being "inclusive" for all skin tones.

The mother-of-four told the February issue of Harper's Bazaar UK: "I've been obsessed with make-up and skincare and wellness for longer than I can remember.

"But I couldn't find what I wanted - clean beauty.

"What is that, even? It's a real grey area.

"I wanted to create a brand of the future - focusing on what's in the formulas but then also sustainability.

"The other thing that was key was making sure it was very inclusive - whether it's make-up or skincare, this is for every skin type and tone, and for both women and men."

In November, Victoria - who has Brooklyn, 20, Romeo, 17, Cruz, 14 and Harper, eight, with retired soccer star husband David Beckham - released her Cell Rejuvenating Priming Moisturiser in collaboration with Professor Augustinus Bader, the German stem-cell scientist behind The Cream, which was named as one of 2019's most popular skincare products.

Bader's product features a patented Trigger Factor Complex that works to jumpstart your skin's repair and renewal functions to heal skin faster and in turn, improve the appearance of fine lines and wrinkles, and as a fan of the cream herself, Victoria was thrilled to work with the scientist.

She said: "It's been a dream to develop, with Augustinus, a priming moisturiser that works to improve the health of my skin and gives me that fresh, natural glow that I love."

The priming moisturiser is a hybrid product that combines primer with moisturiser, and is inspired by Victoria's own skincare routine.

Victoria's product implements Bader's Trigger Factor Complex technology, as well as the lipids, vitamins, and amino acids found in his original cream, but with the added benefit of also smoothing skin so it's prepped for make-up application.

Bader explained: "It's the first priming moisturiser of its kind to care for your skin cells while also preparing your skin for makeup application."

The cream has a lightweight texture that can be work alone to give skin a radiant finish or under make-up, which according to Victoria, "will enhance your products."

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Victoria Beckham wants her beauty line to be 'brand of the future' - FemaleFirst.co.uk

Skin Stem Cells Comments Off on Victoria Beckham wants her beauty line to be ‘brand of the future’ – FemaleFirst.co.uk | January 5th, 2020

Being jam-packed with various essential nutrients like folate, Vitamin A, beta carotene, etc., carrot and ginger can offer you both health and beauty benefits. These kitchen companions can help diabetics to control their blood sugar level and have many more medicinal uses. These vegetables are known to treat ailments like cough and cold, nausea, anxiety, etc. From strengthening your immune system to protecting your against cancer and boosting collagen production, carrot ginger juice can do it all for you. Below, we give you more than one reason to add this juice to your daily diet.

Being a rich source of vitamin A, carrot ginger juice helps in strengthening your immune response. This nutrient is required to form white blood cells in the bone marrow stem cells. Notably, WBC is a significant component of your bodys defence system. So, it is advised to drink this juice on a daily basis. You can add oranges in the juice to make it a bit tasty.

For a healthy skin texture and tone, vitamin C and E are needed. Carrot ginger juice is a rich source of both nutrients. Your skin requires collagen for better elasticity, texture, and strength. Vitamin C helps in the synthesis of this protein and holds the body together. Even if you have a skin wound, you can have this drink and get rid of the problem soon. On the other hand, vitamin E protects your skin from the harmful effects of UV rays.

Carrot ginger juice is a detox drink that is jam-packed with vitamin C, a nutrient that is already linked to providing protection against cancer. The juice contains a compound called gingerol, that can potentially reduce your risk of developing breast, ovarian, and stomach cancers. This is what research published in the European Journal of Pharmacology reveals.

Originally posted here:
Want to Rev up Your Immunity And Improve Skin Health? Consume Carrot Ginger Juice - India.com

Skin Stem Cells Comments Off on Want to Rev up Your Immunity And Improve Skin Health? Consume Carrot Ginger Juice – India.com | January 5th, 2020

Its not easy to choose the right skin creams! There are so many new products on the market, beckoning us to buy them. With fancy campaigns and big budgets, who knows which ones are the best?

While we like to think we actually getbetterwith age, we totally understand that there might be some pesky skin changes you want to address as the years pass. Its difficult to pinpoint exactlywhen to startincorporating anti-aging products into your routine, so we chatted with one of our favorite celebrity experts, Nicole Baca, who createdOverdoseto get the scoop on the best approach to wrinkle creams.

Not only is Baca an award-winning leading independent skincare specialist in the U.S, who produced the top-selling product Overdose,but she is also a well-known advisor and specialist in elite Hollywood circles, and in todays current market, that means everything!

While different age groups require different routines, the best anti-aging product issunblock, which Baca recommends be applied to the face daily as young as possible! In individuals with dry skin,a daily moisturizer,serum, andeye creamshould be started in the early 20s, says Baca.

If the individual has oily skin, traditional anti-aging products can start in their 30s, but most likely they will be using aretinol product to combat acne breakouts, so they are already using preventative measures.

When comparing products, opt for ones with retinol,hyaluronic acid,plant-based stem cells,resveratrol, andglycolic acid. Exfoliation is essential! Baca says.

Armed with that info, we set out to research and find the right anti-aging creams that fight wrinkles. Our list (of course) includes J.Nicoles Overdose.

Ready to find the best wrinkle cream for you? Read on to learn more about our top picks.

Body Merry Retinol Surge Moisturizer $22.98 SHOP NOW

Wildly Popular Aretinol creamcanmakeyourskin appear more youthfulover time, and this is our favorite one at a budget-friendly price. Wed expect to pay more for resultsthislegit, but this steal fromBody Merry truly works to improve aging skin.

TheRetinol Surge Moisturizer addresses wrinkles and uneven skin tone, providing the kind of results youd expect from a professional product.

ELEMIS Pro-Collagen Marine Cream $120.47-$96.00 (20% off) SHOP NOW

Feels Amazing This silky, moisturizing cream not only feels amazing on your skin, but it contains a mix of powerful ingredients like Mediterranean algae, gingko biloba, chlorella, mimosa, and rose that work to visibly reduce fine lines and wrinkles in just 14 days. Fewer linesandplump skin? Yes, please!

OVERDOSE Bio-Hybrid Technology $95.00 SHOP NOW

Skin Care Essentials J.Nicole uses patent-pending formula to combine seven separate skin care products into one easy to use formula. Their unique serum utilizes the high oleic acid found within specially-bred hybrid sunflowers, delivering a super-saturated boost of skin care essentials deep into your skin without any irritation. Simply apply once a day after cleansing for instantly clearer, brighter, and youthful skin.

Rodial Dragons Blood Hyaluronic Night Cream $72.00-$58.50 (19% off) SHOP NOW

Potent Ingredients Rodials Dragons Blood Hyaluronic Night Cream offers potent ingredients in a light, buttery cream that smells divine. This anti-aging cream contains time-released retinol, penetrating deep into the skin as you sleep to help reduce lines and wrinkles. It also contains hyaluronic acid to pump long-lasting hydration into the deepest layers of the skin.

Olay Regenerist Micro-Sculpting Cream $20.03 SHOP NOW

Fast-Acting Formula Give this anti-wrinkle cream by Olay a spin for line-free skin. The fast-action formula starts reducing wrinkles instantly with a blend of hyaluronic acid, vitamin B, and amino-peptides, so if youre in a rush to reduce age marks on a budget, Olay has found the way.

RoC Retinol Correxion Deep Wrinkle Anti-Aging Retinol Night Cream $16.79 SHOP NOW

Works While You Sleep Theres hardly a list of wrinkle creams without mention of RoCs Retinol Correxion products. Our favorite drugstore buy, this night cream uses a retinol-packed formula to improve skin while you sleep! Youll see a reduction incrows feet, under-eye wrinkles, and deep lines with 12 weeks of use.

Derma-E Anti-Wrinkle Renewal Skin Cream $11.96SHOP NOW

Vegan and Cruelty-Free Experience anti-aging benefits around the clock with this cream from Derma-E that can be used day or night. A rich mix of vitamin A (aka retinol), vitamin E, allantoin, panthenol, and nourishing oils works together to soften skin and reduce the look of wrinkles.

Neutrogena Anti-Wrinkle Deep Wrinkle Daily Moisturizer$21.99-$13.47 (39% off) SHOP NOW

Contains Sunscreen When using a retinol, you shouldalwaysbe usingan SPF, too. (Which, TBH, you should be wearing anyway.) This daily moisturizer from Neutrogena containsboth!

Its also formulated withhyaluronic acid,which plumps up skinand helps it retain moisture.

The Inkey List Bakuchiol Moisturizer $9.99 SHOP NOW

Retinol Alternative If you havent yet heard of Bakuchiol, youll want to try this buzzy skincareingredient ASAP! Itsthe gentler, plant-derived alternative to retinol, and provides similar anti-aging effects without any of the irritation or sensitivity to the sun.

Plus, unlike regular retinol,its a safe pick for pregnant or breastfeeding moms, too.You cant beat the value ofThe Inkey Lists under-$10version.

Skinmedica Dermal Repair Cream $103.20 SHOP NOW

Skincare Staple A staple from one of Vielbigs recommended brands, this all-encompassing hydrating treatment deserves a spot in your skincare regimen ASAP. Formulated with hyaluronic acid, vitamin C, and other wrinkle-fighting ingredients, this cream effectively penetrates the skin to turn back the clock and provide you witha more youthful appearance.

SkinCeuticals A.G.E. Interrupter Mature Skin Treatment $157.75 SHOP NOW

A Best-Seller This best-selling anti-aging cream from SkinCeuticals slows the loss of elasticity in your skin and keeps your collagen levels up. Formulated with 30% concentration of Pro-Xylane, 4% blueberry extract, and 0.2% phytosphingosine, this anti-wrinkle treatment helps restore the loss of visible skin firmness.

Obagi Hydrate Luxe $74.00 SHOP NOW

Expert-Approved A favorite brand recommended byour skincare expert, this moisture-rich cream from Dr. Obagi is life-changing. It features nourishing shea butter, along with peptides designed to capture moisture andsupport cell-repair processes.

Dr. Dennis Gross C+ Collagen Deep Cream $72.00 SHOP NOW

Deeply-Penetrating When it comes to youthful-looking skin, collagen is one of your besties. Implement Dr. Dennis Grosss deeply penetrating cream into your skin care routine to postpone age spots and wrinkles.

The potent, vitamin C-infused formula also features sunflower, rice bran, and camellia japonica seed oils that work to increase moisture retention.

DHC CoQ10 Quick Gel Brightening Moisture $61.26 SHOP NOW

Absorbs Quickly How did we live without this anti-aging wonder cream from DHC? Bursting with age-defying coenzyme Q10, this antioxidant-rich gel cream absorbs quickly to deliver potent ingredients in a flash. It promotes elasticity while vitamin C and daisy extract help brighten for a more luminous complexion.

This cream tones, brightens, and moisturizes in one step, making itperfect to wear with or without makeup.

IMAGE Skincare Ageless Total Overnight Retinol Masque $72.00$-60.39 (16% off) SHOP NOW

Retinol-Infused Goodness We love using this retinol-infused goodness from IMAGE Skincare as a night cream around threetimes per week. Simply slather it on before bed, and itll continuously release marine collagen microspheres and retinol into the skin to lock in moisture while you sleep. Youll wake up looking fresh and young!

Dr. Barbara Sturm Anti-Aging Body Cream $95.00 SHOP NOW

For Your Whole Body While we know your facial anti-aging cream is top of mind, dont forget about the rest of your skin! We live for Dr. Barbara Sturms Anti-Aging Body Cream. Its on the pricier side, but the serious results make it worth the splurge.

It contains a slew of nourishing ingredients, including olive oil, lactic acid, vitamin C, and vitamin B-5, to improve the appearance of fine lines and wrinkles on your body.

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We asked beauty expert Nicole Baca for advice on the best skincare treatments on the market - Globe Stats

Skin Stem Cells Comments Off on We asked beauty expert Nicole Baca for advice on the best skincare treatments on the market – Globe Stats | January 5th, 2020

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MCLEAN, United States (AFP) When a person's immune system is impaired by a genetic disease a bone marrow transplant can be a powerful therapeutic tool, but with a major downside during the first few months the recipient's defences against viruses are severely weakened. The slightest infection can lead to a hospital trip.

A still-experimental type of treatment known as T-cell therapy aims to assist during this vulnerable period the months during which the body is rebuilding its natural defences. After two decades of clinical trials, the technology has been refined and is being used to treat more and more patients, many of them children.

A boy named Johan is one of them.

Today he is a mischievous, smiling toddler, with a thick shock of light-brown hair, who never tires, playfully tormenting the family's puppy, Henry.

There is no sign of the three-year-long medical and emotional roller coaster ride he and his family, who live in an affluent Washington suburb, have been on.

The first traumatic surprise came with the results of a pregnancy test Johan was not planned.

That was a huge shock. I cried, said his mother, 39-year-old Maren Chamorro.

Risky procedure

She had known since childhood that she carried a gene that can be fatal in a child's first 10 years, chronic granulomatous disease (CGD).

Her brother died of it at the age of seven. The inexorable laws of genetics meant that Maren had a one in four chance of transmitting it to her child.

For their first children, she and her husband Ricardo had chosen invitro fertilisation, allowing the embryos to be genetically tested before implantation.

Their twins Thomas and Joanna were born both disease-free seven and a half years ago.

But in Johan's case, a post-birth genetic test quickly confirmed the worst: He had CGD.

After conferring with experts at Children's National Hospital in Washington, the couple took one of the most important decisions of their lives, Johan would receive a bone marrow transplant a risky procedure but one that would give him a chance of a cure.

Obviously, the fact that Maren had lost a sibling at a young age from the disease played a big role, Ricardo confided.

Bone marrow, the spongy tissue inside bones, serves as the body's factory for the production of blood cells both red and white.

His brother's immune system

Johan's white blood cells were incapable of fighting off bacteria and fungal infections. A simple bacterial infection, of negligible concern in a healthy child, could spread out of control in his young body.

Luckily, Johan's brother Thomas, six years old at the time, was a perfect match. In April 2018, doctors first cleansed Johan's marrow using chemotherapy. They then took a small amount of marrow from Thomas's hip bones using a long, thin needle.

From that sample they extracted supercells, as Thomas calls them stem cells, which they reinjected into Johan's veins. Those cells would eventually settle in his bone marrow and begin producing normal white blood cells.

The second step was preventive cell therapy, under an experimental programme led by immunologist Michael Keller at Children's National Hospital.

The part of the immune system that protects against bacteria can be rebuilt in only a matter of weeks; but for viruses, the natural process takes at least three months.

Hurdles remain

From Thomas's blood, doctors extracted specialised white blood cells T-cells that had already encountered six viruses.

Keller grew them for 10 days in an incubator, creating an army of hundreds of millions of those specialised T-cells. The result: A fluffy white substance contained in a small glass vial.

Those T-cells were then injected into Johan's veins, immediately conferring protection against the six viruses.

He has his brother's immune system, said Keller, an assistant professor at Children's National.

Johan's mother confirmed as much: Today, when Thomas and Johan catch a cold they have the same symptoms, and for nearly the same amount of time.

I think it's pretty cool to have immunity from your big brother, Maren Chamorro said.

This therapeutic approach boosting the body's immune system using cells from a donor or one's own genetically modified cells is known as immunotherapy.

Its main use so far has been against cancer, but Keller hopes it will soon become available against viruses for patients, like Johan, who suffer from depressed immune systems.

The chief obstacles to that happening are the complexity of the process and the costs, which can run to many thousands of dollars. These factors currently restrict the procedure to some 30 medical centres in the United States.

For Johan, a year and a half after his bone marrow transplant, everything points to a complete success.

It's neat to see him processing things, and especially play outside in the mud, his mother said.

You know, what a gift!

Her only concern now is the same as any mother would have that when her son does fall ill, others in the family might catch the same bug.

Now you can read the Jamaica Observer ePaper anytime, anywhere. The Jamaica Observer ePaper is available to you at home or at work, and is the same edition as the printed copy available at http://bit.ly/epaperlive

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The supercells' that cured an infants genetic illness - Jamaica Observer

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Kolar MK, Kingham PJ, Novikova LN, Wiberg M, Novikov LN. The therapeutic effects of human adipose-derived stem cells in a rat cervical spinal cord injury model. Stem Cells Dev. 2014;23:165974.

Kokai LE, Marra K, Rubin JP. Adipose stem cells: biology and clinical applications for tissue repair and regeneration. Transl Res. 2014;163:399408.

Kim Y, Lee SH, Kim WH, Kweon OK. Transplantation of adipose derived mesenchymal stem cells for acute thoracolumbar disc disease with no deep pain perception in dogs. J Vet Sci. 2016;17:1236.

Zhou J, Lu P, Ren H, Zheng Z, Ji J, Liu H, Jiang F, Ling S, Heng BC, Hu X, Ouyang H. 17beta-estradiol protects human eyelid-derived adipose stem cells against cytotoxicity and increases transplanted cell survival in spinal cord injury. J Cell Mol Med. 2014;18:32643.

Hyun J, Grova M, Nejadnik H, Lo D, Morrison S, Montoro D, Chung M, Zimmermann A, Walmsley GG, Lee M, Daldrup-Link H, Wan DC, Longaker MT. Enhancing in vivo survival of adipose-derived stromal cells through Bcl-2 overexpression using a minicircle vector. Stem Cells Transl Med. 2013;2:690702.

Lee SH, Kim Y, Rhew D, Kuk M, Kim M, Kim WH, Kweon OK. Effect of the combination of mesenchymal stromal cells and chondroitinase ABC on chronic spinal cord injury. Cytotherapy. 2015;17:137483.

Hur JW, Cho TH, Park DH, Lee JB, Park JY, Chung YG. Intrathecal transplantation of autologous adipose-derived mesenchymal stem cells for treating spinal cord injury: a human trial. J Spinal Cord Med. 2016;39:65564.

Sanluis-Verdes A, Sanluis-Verdes N, Manso-Revilla MJ, Castro-Castro AM, Pombo-Otero J, Fraga-Marino M, Sanchez-Ibanez J, Domenech N, Rendal-Vazquez ME. Tissue engineering for neurodegenerative diseases using human amniotic membrane and umbilical cord. Cell Tissue Bank. 2017;18:115.

Caron I, Rossi F, Papa S, Aloe R, Sculco M, Mauri E, Sacchetti A, Erba E, Panini N, Parazzi V, Barilani M, Forloni G, Perale G, Lazzari L, Veglianese P. A new three dimensional biomimetic hydrogel to deliver factors secreted by human mesenchymal stem cells in spinal cord injury. Biomaterials. 2016;75:13547.

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Gao S, Ding J, Xiao HJ, Li ZQ, Chen Y, Zhou XS, Wang JE, Wu J, Shi WZ. Anti-inflammatory and anti-apoptotic effect of combined treatment with methylprednisolone and amniotic membrane mesenchymal stem cells after spinal cord injury in rats. Neurochem Res. 2014;39:154452.

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Liu CB, Huang H, Sun P, Ma SZ, Liu AH, Xue J, Fu JH, Liang YQ, Liu B, Wu DY, Lu SH, Zhang XZ. Human umbilical cord-derived mesenchymal stromal cells improve left ventricular function, perfusion, and remodeling in a porcine model of chronic myocardial ischemia. Stem Cells Transl Med. 2016;5:100413.

Park SE, Jung NY, Lee NK, Lee J, Hyung B, Myeong SH, Kim HS, Suh YL, Lee JI, Cho KR, Kim DH, Choi SJ, Chang JW, Na DL. Distribution of human umbilical cord blood-derived mesenchymal stem cells (hUCB-MSCs) in canines after intracerebroventricular injection. Neurobiol Aging. 2016;47:192200.

Kang KS, Kim SW, Oh YH, Yu JW, Kim KY, Park HK, Song CH, Han H. A 37-year-old spinal cord-injured female patient, transplanted of multipotent stem cells from human UC blood, with improved sensory perception and mobility, both functionally and morphologically: a case study. Cytotherapy. 2005;7:36873.

Yao L, He C, Zhao Y, Wang J, Tang M, Li J, Wu Y, Ao L, Hu X. Human umbilical cord blood stem cell transplantation for the treatment of chronic spinal cord injury: electrophysiological changes and long-term efficacy. Neural Regen Res. 2013;8:397403.

Zhu H, Poon W, Liu Y, Leung GK, Wong Y, Feng Y, Ng SCP, Tsang KS, Sun DTF, Yeung DK, Shen C, Niu F, Xu Z, Tan P, Tang S, Gao H, Cha Y, So KF, Fleischaker R, Sun D, Chen J, Lai J, Cheng W, Young W. Phase I-II clinical trial assessing safety and efficacy of umbilical cord blood mononuclear cell transplant therapy of chronic complete spinal cord injury. Cell Transplant. 2016;25:192543.

Guo L, Rolfe AJ, Wang X, Tai W, Cheng Z, Cao K, Chen X, Xu Y, Sun D, Li J, He X, Young W, Fan J, Ren Y. Rescuing macrophage normal function in spinal cord injury with embryonic stem cell conditioned media. Mol Brain. 2016;9:48.

Salewski RP, Mitchell RA, Shen C, Fehlings MG. Transplantation of neural stem cells clonally derived from embryonic stem cells promotes recovery after murine spinal cord injury. Stem Cells Dev. 2015;24:3650.

Koch P, Opitz T, Steinbeck JA, Ladewig J, Brustle O. A rosette-type, self-renewing human ES cell-derived neural stem cell with potential for in vitro instruction and synaptic integration. Proc Natl Acad Sci U S A. 2009;106:322530.

Shin S, Mitalipova M, Noggle S, Tibbitts D, Venable A, Rao R, Stice SL. Long-term proliferation of human embryonic stem cell-derived neuroepithelial cells using defined adherent culture conditions. Stem Cells. 2006;24:12538.

Chang YW, Goff LA, Li H, Kane-Goldsmith N, Tzatzalos E, Hart RP, Young W, Grumet M. Rapid induction of genes associated with tissue protection and neural development in contused adult spinal cord after radial glial cell transplantation. J Neurotrauma. 2009;26:97993.

Moreno-Manzano V, Rodriguez-Jimenez FJ, Garcia-Rosello M, Lainez S, Erceg S, Calvo MT, Ronaghi M, Lloret M, Planells-Cases R, Sanchez-Puelles JM, Stojkovic M. Activated spinal cord ependymal stem cells rescue neurological function. Stem Cells. 2009;27:73343.

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Crosstalk between stem cell and spinal cord injury ...

Spinal Cord Stem Cells Comments Off on Crosstalk between stem cell and spinal cord injury … | January 5th, 2020

The reconstitution of the blood system in humans holds great therapeutic potential to treat many disorders, like blood cancers, sickle-cell anemia and others. Successful reconstitution requires the transplantation and engraftment of hematopoietic (or blood) stem cells (HSCs), which after reaching their niche, start producing all types of blood cells, including platelets, white and red blood cells.

In current clinical practice, this is carried out by infusing HSCs obtained from a matched donor who is immunologically compatible with the patient in need (allogeneic transplantation), or by the expansion of the patients own HSCs in the lab, and then re-infusing them back into the patient (ex-vivo, autologous transplantation).

However, the utility of both routes is currently limited by a number of factors. First, in the case of allogeneic transplantation, the scarcity of matched donors significantly increases the waiting time, which could be detrimental to the patient. Second, the ex vivo expansion of HSCs, whether allogeneic or autologous, has been a challenging task, due to the limited proliferative potential these cells exhibit in culture. These limitations have raised the need for other sources of HSCs that would alleviate the need for matched donors and yield functional HSCs in large quantities.

In 2007, Professor Shinya Yamanaka and colleagues demonstrated that somatic cells, like skin fibroblasts, could be reprogrammed back to a cellular state that resembled human embryonic stem cells (hESCs), which are a group of cells found in the blastocyst-stage human embryo and contribute solely to the development of the human fetus during pregnancy. The reprogrammed cells were termed, Induced Pluripotent Stem Cells (iPSCs).

In addition to their developmental potential, human ESCs and iPS cells display unlimited proliferative potential in culture, which makes them an ideal source of cells for regenerative medicine in general and for hematopoietic differentiation to obtain possibly unlimited quantities of HSCs. Therefore, there has been a growing interest to harness the potential of these cells for treating blood disorders.

However, advancement in deriving functional HSCs from human pluripotent stem cells has been slow. This has been attributed to incomplete understanding of the molecular mechanisms underlying normal hematopoiesis. In this review, the authors discuss the latest efforts to generate HSCs capable of long-term engraftment and reconstitution of the blood system from human pluripotent stem cells. Stem cell research has witnessed milestone achievements in this area in the last couple of years, the significance of which are discussed and analyzed in detail.

The authors additionally discuss two highly important families of transcription factors in the context of hematopoiesis and hematopoietic differentiation, the Homeobox (HOX) and GATA proteins. These are thought of as master regulators, in the sense of having numerous transcriptional targets, which upon activation, could elicit significant changes in cell identity. The authors hypothesize that precise temporal control of the levels of certain members of these families during hematopoietic differentiation could yield functional HSCs capable of long-term engraftment.

The authors conclude the review with a summary of future perspectives, in which they discuss how newly developed techniques, like the deactivated-Cas9 (dCas9) gene-expression control system, can be utilized during the course of hematopoietic differentiation of pluripotent stem cells for precise temporal control of the aforementioned master regulators to achieve functional HSCs.

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Making Blood On Demand: How Far Have We Come? - Eurasia Review

Skin Stem Cells Comments Off on Making Blood On Demand: How Far Have We Come? – Eurasia Review | January 5th, 2020

There was a head-scratching moment when Martin Swales answered his front door and a priest handed him a letter.

The mystery was quickly solved. It contained a thank you note from someone whose life Martin had saved.

He knew his bone marrow had been given to someone called Jan and imagined it was a woman in Britain.

In fact the recipient was dad Jan Zemek 4,500 miles away in the US.

And Martins gift of life has led to an extraordinary 30-year bond between the pair, who are like blood brothers.

Jan named his second daughter Martina in honour of his hero and Martin is godfather to his third girl.

Retired welder Martin, 58, of Guisborough, North Yorks, said: Donating bone marrow didnt just save Jans life, it changed mine as well.

The first time I met Jan, I put my arms around him and he hugged me back.

It felt natural, like I was welcoming my brother. It feels like our two families have become one.

They each have three grown-up children and have visited each other for baptisms, graduations, and weddings.

Martin recently went to Switzerland, where Jan lives with his family, to celebrate 30 years since the transplant and present his blood brother with a Walk of Fame plaque.

It includes the touching message: Stood strong, fought hard, and won. You are a survivor.

The mens amazing and heart-warming story dates from 1986 when Martin joined the Anthony Nolan stem cell register after an appeal to save two girls living in the North East.

He was not a match for the girls but in 1989 was called by the register because he could be for Jan.

Martin said: It was quite a shock because Id pretty much forgotten about the register. They told me I was a possible match for someone and what was involved. I said yes straight away. I wanted to help if I could.

Despite the discomfort, Martin gave bone marrow from his hip at a clinic in Harley Street that August. Doctors extracted it from inside his hip using a long needle. Today most donations are no more invasive than giving blood.

Martin spent two nights in hospital. He said: It doesnt take long but at the time I was suffering from sciatica so I think I found it a bit more painful than most. It was an uncomfortable journey home on the train.Anthony Nolan covered the cost of the trip.

Jan, a 27-year-old dad, was diagnosed with leukaemia in 1987. Initially doctors kept the news from him as no treatment was available in the Czech Republic, where he lived.

Jan said: I was diagnosed one year after the Chernobyl tragedy, weve never known if that radiation was to blame for my cancer. I suddenly grew very tired, nobody knew the reason.

I didnt know how sick I was because the doctors wouldnt tell me.

My wife, who was then my girlfriend, went to the same doctors and they told her, Dont marry this guy, dont have children with him. He is going to die in two years.

But Radka ignored their warning and insisted on marrying Jan in 1987.

His only hope was a bone marrow transplant. Weeks later he left for the US with his dad, who planned to be his donor.

Jan said: A few months earlier, I read in the paper the opera singer Jos Carreras was diagnosed with a similar blood disease and was going to the same US centre for a transplant.

They arrived with less than 40 in their pockets and discovered a transplant from his dad would give Jan only a 15 per cent chance of survival.

Instead doctors advised them to find a donor. It took two years and 10,000 to test potential donors before they found a perfect match in Martin.

By then Jan and Radka had become parents to their first daughter, Jana.

Jan needed to raise more than 100,000 to fund the transplant.

He said: It was such a huge amount of money to raise but when you are dying you have no choice.

There were 12 rival local radio stations but they all got together to run a joint appeal, which they broadcast at the same time. It was incredible.

Jan did a sponsored run, gave talks about his ordeal to church congregations to request donations, and wrote to celebrities, especially those with links to the Czech Republic.

Donald Trump s ex-wife Ivana gave 1,000, as did One Flew Over the Cuckoos Nest director Milos Forman. Jan said: The response was crazy. So many people donated 20 dollars or 50.

Martins bone marrow was flown to the Fred Hutchinson Cancer Research Center in Seattle, where Jan was waiting in an isolation room.

He had been blasted with chemo and radiotherapy so his immune system would not attack Martins transplanted cells.

Normally, under strict anonymity rules to protect donor and recipient, Martin and Jan would have been unable to contact each other for years.

But a priest from the North East of England working at the hospital recognised Martins address when the bag of bone marrow arrived.

He offered to take a photo of Jan, a thank you letter, and a Czech garnet stone to Martin when he returned home in 1990.

Martin said: I was stunned. I had no idea my bone marrow had travelled so far. Knowing Id helped a young father, just like me, brought home how important it was and how easily it could have been me waiting for a stranger to save my life.

I wrote straight back. The priest also brought a letter from a couple whose daughter was in the same hospital.

Her transplant didnt work. Sadly she died, but they wrote to thank me for saving Jan. Responding to them was much harder. How do you find the right words?

Martin and Jan kept in touch. When Jans second daughter was born in 1991, he and Radka named her after Martin.

Jan said: How do you repay someone who saved your life? Naming our daughter after Martin was our way of showing him we would never forget what he did for us.

Hes not just the man who saved my life. He is a nice guy. Thats why were so close.

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Jan, 59, and his family moved to Switzerland, where he landed a job with a sports marketing firm that works with World Athletics.

In 1992 his job brought him to Crystal Palace in South London and he spent a few days with Martin and family.

Jans youngest daughter Michaela was born in 1995 and he invited Martin and his family to Switzerland for the baptism and asked him to be godfather.

The two families continued to visit each other and holidayed together in the Czech capital Prague. When Jans eldest, Jana, was studying at Newcastle University, she regularly spent weekends with Martin and his wife Tracey.

Martin said: It meant so much to visit Jan for the 30 anniversary of his transplant earlier this year.

"They showed us the sights and we went up the mountains. It was brilliant. I could never have imagined this when I joined the stem cell register all those years ago.

He added: I hope Martin and I will be able to celebrate another anniversary together in ten years.

The Anthony Nolan register matches potential donors to patients needing stem cell transplants and does vital research. To join, donate or find out more, see anthonynolan.org .

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Bone marrow donor's amazing 30 year bond with man he saved - Mirror Online

Bone Marrow Stem Cells Comments Off on Bone marrow donor’s amazing 30 year bond with man he saved – Mirror Online | January 5th, 2020

IN the summer of 2019, a mother in Nashville, Tennessee in the United States, with a seemingly incurable genetic disorder finally found an end to her suffering by editing her genome.

Victoria Grays recovery from sickle cell disease, which had caused her painful seizures, came in a year of breakthroughs in one of the hottest areas of medical research gene therapy.

I have hoped for a cure since I was about 11, the 34-year-old said.

Since I received the new cells, I have been able to enjoy more time with my family without worrying about pain or an out-of-the-blue emergency.

Over several weeks, Grays blood was drawn so that doctors could get to the cause of her illness stem cells from her bone marrow that were making deformed red blood cells.

The stem cells were sent to a Scottish laboratory, where their DNA was modified using Crispr/Cas9 pronounced Crisper a new tool informally known as a molecular scissors.

The genetically-edited cells were transfused back into Grays veins and bone marrow. A month later, she was producing normal blood cells.

Medics warn that caution is necessary, but theoretically, she has been cured.

This is one patient. This is early results. We need to see how it works out in other patients, said her doctor, Haydar Frangoul, at the Sarah Cannon Research Institute in Nashville.

But these results are really exciting.

In Germany, a 19-year-old woman was treated with a similar method for a different blood disease beta thalassemia.

She had previously needed 16 blood transfusions per year. Nine months later, she is completely free of that burden.

For decades, the DNA of living organisms such as corn and salmon has been modified. But Crispr, invented in 2012, made gene editing more widely accessible.

It is much simpler than preceding technology, cheaper and easy to use in small labs.

The technique has given new impetus to the perennial debate over the wisdom of humanity manipulating life itself.

Its all developing very quickly, said French geneticist Emmanuelle Charpentier, one of Crisprs inventors and the co-founder of Crispr Therapeutics, the biotech company conducting the clinical trials involving Gray and the German patient.

Gene cures

Crispr was the latest breakthrough in a year of great strides in gene therapy, a medical adventure that started three decades ago, when the first TV telethons were raising money for children with muscular dystrophy.

Scientists practising the technique insert a normal gene into cells containing a defective gene.

It does the work the original could not, such as making normal red blood cells in Grays case or making tumour-killing super white blood cells for a cancer patient.

Crispr goes even further: instead of adding a gene, the tool edits the genome itself.

After decades of research and clinical trials on a genetic fix to genetic disorders, 2019 saw a historic milestone: approval to bring to market the first gene therapies for a neuromuscular disease in the US and a blood disease in the European Union.

They join several other gene therapies bringing the total to eight approved in recent years to treat certain cancers and an inherited blindness.

Serge Braun, the scientific director of the French Muscular Dystrophy Association, sees 2019 as a turning point that will lead to a medical revolution.

Twenty-five, 30 years, thats the time it had to take, he said. It took a generation for gene therapy to become a reality. Now, its only going to go faster.

Just outside Washington, at the US National Institutes of Health (NIH), researchers are also celebrating a breakthrough period.

We have hit an inflection point, said US NIHs associate director for science policy Carrie Wolinetz.

These therapies are exorbitantly expensive, however, costing up to US$2 million (RM8.18 million) meaning patients face grueling negotiations with their insurance companies.

They also involve a complex regimen of procedures that are only available in wealthy countries.

Gray spent months in hospital getting blood drawn, undergoing chemotherapy, having edited stem cells reintroduced via transfusion and fighting a general infection.

You cannot do this in a community hospital close to home, said her doctor.

However, the number of approved gene therapies will increase to about 40 by 2022, according to Massachusetts Institute of Technology (MIT) researchers.

They will mostly target cancers and diseases that affect muscles, the eyes and the nervous system.

In this Oct 10, 2018, photo, He speaks during an interview at his laboratory in Shenzhen, China. The scientist was recently sentenced to three years in prison for practicing medicine illegally and fined 3 million yuan (RM1.76 million). AP

Bioterrorism potential

Another problem with Crispr is that its relative simplicity has triggered the imaginations of rogue practitioners who dont necessarily share the medical ethics of Western medicine.

In 2018 in China, scientist He Jiankui triggered an international scandal and his excommunication from the scientific community when he used Crispr to create what he called the first gene-edited humans.

The biophysicist said he had altered the DNA (deoxyribonucleic acid) of human embryos that became twin girls Lulu and Nana.

His goal was to create a mutation that would prevent the girls from contracting HIV (human immunodeficiency virus), even though there was no specific reason to put them through the process.

That technology is not safe, said Kiran Musunuru, a genetics professor at the University of Pennsylvania, explaining that the Crispr scissors often cut next to the targeted gene, causing unexpected mutations.

Its very easy to do if you dont care about the consequences, he added.

Despite the ethical pitfalls, restraint seems mainly to have prevailed so far.

The community is keeping a close eye on Russia, where biologist Denis Rebrikov has said he wants to use Crispr to help deaf parents have children without the disability.

There is also the temptation to genetically edit entire animal species, e.g. malaria-causing mosquitoes in Burkina Faso or mice hosting ticks that carry Lyme disease in the US.

The researchers in charge of those projects are advancing carefully however, fully aware of the unpredictability of chain reactions on the ecosystem.

Charpentier doesnt believe in the more dystopian scenarios predicted for gene therapy, including American biohackers injecting themselves with Crispr technology bought online.

Not everyone is a biologist or scientist, she said.

And the possibility of military hijacking to create soldier-killing viruses or bacteria that would ravage enemies crops?

Charpentier thinks that technology generally tends to be used for the better.

Im a bacteriologist -- weve been talking about bioterrorism for years, she said. Nothing has ever happened. AFP Relaxnews

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Gene editing breakthroughs that cured genetic diseases in 2019 - The Star Online

Bone Marrow Stem Cells Comments Off on Gene editing breakthroughs that cured genetic diseases in 2019 – The Star Online | January 5th, 2020

DURHAM Hemophilia. Cystic fibrosis. Duchenne muscular dystrophy. Huntingtons disease. These are just a few of the thousands of disorders caused by mutations in the bodys DNA. Treating the root causes of these debilitating diseases has become possible only recently, thanks to the development of genome editing tools such as CRISPR, which can change DNA sequences in cells and tissues to correct fundamental errors at the source but significant hurdles must be overcome before genome-editing treatments are ready for use in humans.

Enter the National Institutes of Health Common FundsSomatic Cell Genome Editing (SCGE)program, established in 2018 to help researchers develop and assess accurate, safe and effective genome editing therapies for use in the cells and tissues of the body (aka somatic cells) that are affected by each of these diseases.

Todaywith three ongoing grants totaling more than $6 million in research fundingDuke University is tied with Yale University, UC Berkeley and UC Davis for the most projects supported by the NIH SCGE Program.

In the 2019 SCGE awards cycle, Charles Gersbach, the Rooney Family Associate Professor of Biomedical Engineering, and collaborators across Duke and North Carolina State University received two grants: the first will allow them to study how CRISPR genome editing affects engineered human muscle tissues, while the second project will develop new CRISPR tools to turn genes on and off rather than permanently alter the targeted DNA sequence. This work builds on a 2018 SCGE grant, led by Aravind Asokan, professor and director of gene therapy in the Department of Surgery, which focuses on using adeno-associated viruses to deliver gene editing tools to neuromuscular tissue.

Duke engineers improve CRISPR genome editing with biomedical tails

There is an amazing team of engineers, scientists and clinicians at Duke and the broader Research Triangle coalescing around the challenges of studying and manipulating the human genome to treat diseasefrom delivery to modeling to building new tools, said Gersbach, who with his colleagues recently launched the Duke Center for Advanced Genomic Technologies (CAGT), a collaboration of the Pratt School of Engineering, Trinity College of Arts and Sciences, and School of Medicine. Were very excited to be at the center of those efforts and greatly appreciate the support of the NIH SCGE Program to realize this vision.

For their first grant, Gersbach will collaborate with fellow Duke biomedical engineering faculty Nenad Bursac and George Truskey to monitor how genome editing affects engineered human muscle tissue. Through their new project, the team will use human pluripotent stem cells to make human muscle tissues in the lab, specifically skeletal and cardiac muscle, which are often affected by genetic diseases. These systems will then serve as a more accurate model for monitoring the health of human tissues, on-target and off-target genome modifications, tissue regeneration, and possible immune responses during CRISPR-mediated genome editing.

Duke researchers: Single CRISPR treatment provides long-term benefits in mice

Currently, most genetic testing occurs using animal models, but those dont always accurately replicate the human response to therapy, says Truskey, the Goodson Professor of Biomedical Engineering.

Bursac adds, We have a long history of engineering human cardiac and skeletal muscle tissues with the right cell types and physiology to model the response to gene editing systems like CRISPR. With these platforms, we hope to help predict how muscle will respond in a human trial.

Gersbach will work with Tim Reddy, a Duke associate professor of biostatistics and bioinformatics, and Rodolphe Barrangou, the Todd R. Klaenhammer Distinguished Professor in Probiotics Research at North Carolina State University, on the second grant. According to Gersbach, this has the potential to extend the impact of genome editing technologies to a greater diversity of diseases, as many common diseases, such as neurodegenerative and autoimmune conditions, result from too much or too little of certain genes rather than a single genetic mutation. This work builds on previous collaborations between Gersbach, Barrangou and Reddy developing bothnew CRISPR systems for gene regulationandto regulate the epigenome rather than permanently delete DNA sequences.

Aravind Asokan leads Dukes initial SCGE grant, which explores the the evolution of next generation of adeno-associated viruses (AAVs), which have emerged as a safe and effective system to deliver gene therapies to targeted cells, especially those involved in neuromuscular diseases like spinal muscular atrophy, Duchenne muscular dystrophy and other myopathies. However, delivery of genome editing tools to the stem cells of neuromuscular tissue is particularly challenging. This collaboration between Asokan and Gersbach builds on their previous work in usingAAV and CRISPR to treat animal models of DMD.

We aim to correct mutations not just in the mature muscle cells, but also in the muscle stem cells that regenerate skeletal muscle tissue, explainsAsokan. This approach is critical to ensuring long-term stability of genome editing in muscle and ultimately we hope to establish a paradigm where our cross-cutting viral evolution approach can enable efficient editing in multiple organ systems.

Click through to learn more about theDuke Center for Advanced Genomic Technologies.

(C) Duke University

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Duke researchers land $6M in federal grants to advance gene editing - WRAL Tech Wire

Cardiac Stem Cells Comments Off on Duke researchers land $6M in federal grants to advance gene editing – WRAL Tech Wire | January 5th, 2020

If your new year's resolutions includeorganizingthe skincare products taking over your medicine cabinet, checking the expiration dates on your makeup, and tossing those almostempty shampoo and conditioner bottles that have been taking up space in your shower since 2018, I've got some bad news for you:You're probably going to hit pause on reassessing your beauty routineuntil February.Thanks to January'snew beauty product launches, your collection is definitelygoing to grow this month.

Tatcha'sinnovative, travel-friendly serum stick will be the one skincare product you pack for every trip you take, while OLEHENRIKSEN'scleanseris like a refreshing fruit juice for your face. As for makeup, IT Cosmetics has created an uber-comfortable matte lipstick, and Hourglass' concealer is a long-wear formula that doesnotcrease.

Get exclusive discounts, celeb inspo, & more.

RELATED:All the Products Our Beauty Editors Loved Using in December

When it comes to haircare, the drugstore is the place to be. Celebrity hairstylist Kristin Ess has added fragrance-free products to her affordable namesake haircare line, and Pantenejust expanded its Gold Series Collection for natural hair with a hydrating, protective cream specifically formulated for braided styles.

While thesenew haircare, skincare, and makeup products are exciting, there's no question that having so many options can be overwhelming. That's why we've done the work topickout the top 20 worth spending your hard-earned coin on.

VIDEO:What Every Beginner Needs to Have in Their Makeup Kit

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The 20 Best New Beauty Products That'll Help You Kick 2020 Off Right - InStyle

Skin Stem Cells Comments Off on The 20 Best New Beauty Products That’ll Help You Kick 2020 Off Right – InStyle | January 4th, 2020

Fertility expert Marcelle Cedars discusses the future of reproductive medicine.

By Ariel Bleicher UCSF Magazine

Advances in medicine and public health have dramatically extended the human lifespan. Our hearts, lungs, and other vital organs now last 79 years on average. For women, however, the ovaries which stop functioning at an average 51 years remain a stubborn exception. That may soon change, says fertility expert Marcelle Cedars, MD, during a conversation on the future of reproductive medicine.

There are two aspects. One is qualitative. As a woman ages, the quality of her eggs meaning their capacity to make a healthy baby declines. We understand very little about what causes this decline. If we understood that process better, we could dramatically impact fertility success rates.

The other aspect is quantitative. Women are born with a finite number of eggs, and they lose those eggs throughout their lifetime. In fact, that rapid decline in egg numbers starts even before birth. Theres a peak in utero of five to six million eggs. At birth, a woman has only about 1.5 million eggs; at the time of puberty, about 500,000. Through genetics research, were learning that the rate of this decline and the variability from woman to woman is largely driven by ones genes.

Exactly. But what if we could use your genetics and other biological data to understand your unique fertility risks and develop therapies specifically for you or for groups of women like you? This approach is called precision medicine. It has made a huge impact in the world of cancer in terms of improving survival rates. But in the field of reproductive health, precision medicine is still in its infancy.

Potentially. If we can pinpoint the mechanisms of ovarian aging, we could potentially develop a therapy that enables you to still have healthy eggs into your 50s, possibly your 60s. But just because we can do something doesnt always mean we should do it. We know that as women get older, pregnancies are more complicated. You have higher risk for things like high blood pressure, diabetes, and preterm labor. There are many downstream implications, both for the mothers health and the childs.

I dont think the goal should be to enable women to get pregnant into their 60s. Rather, we want women to have the best reproductive lifespan possible to be able to have children when they want to and to not have children when they don't want to and to have a society that supports women across that spectrum.

Were starting to believe that some of the same cellular mechanisms that underlie general aging might also control ovarian aging. This revelation makes the ovary even more interesting to study because its early demise could be a unique window into the bodys aging process. If we can identify cases of accelerated ovarian aging and understand the underlying causes, we might be able to improve not only reproductive function in individual women but also overall health and longevity for all women.

Samesex couples having genetically related children is probably on the horizon. Scientists are learning how to take skin cells or blood cells and turn them into stem cells, which can then be turned into eggs or sperm. Thats not science fiction; its already happening. We just need to figure out how to do it well and safely in humans.

Well probably also see germline engineering. Thats the process of editing genes in reproductive cells or embryos. It has the potential to cure disease before birth. This technology is here. But will society be ready to accept it? A lot of questions need to be answered before its put to use. In addition to technical hurdles, there are innumerable social issues. For instance, if we can eliminate a certain disease, will there be less focus on treatments for people who still have the disease? And what about access to care and social equity? Who would be able to afford these procedures? How will they be applied?

Restrictions are currently preventing the U.S. government from funding research that involves the manipulation of human embryos. As a result, funding for reproductive science is low, which has driven a lot of experts out of academia. If we want to see a revolution in reproductive health, like whats happening with precision cancer medicine, we need to invest in the development of scientific knowledge that will move this field forward.

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Research Jan. 2, 2020 The End of Infertility Is in Sight - UCSF News Services

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