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Clinical trial shows ability of stem cell-based topical solution to regrow hair

May 18, 2020

Durham, NC - The results of a clinical trial released today in STEM CELLS Translational Medicine demonstrate how a topical solution made up of stem cells leads to the regrowth of hair for people with a common type of baldness.

Androgenetic alopecia (AGA) - commonly known as male-pattern baldness (female-pattern baldness in women) -- is a condition caused by genetic, hormonal and environmental factors. It affects an estimated 50 percent of all men and almost as many women older than 50. While it is not a life-threatening condition, AGA can lower a person's self-esteem and psychological well-being. There are a few FDA-approved medications to treat hair loss, but the most effective can have side effects such as loss of libido and erectile dysfunction. Therefore, the search continues for a safer, effective treatment.

Adipose tissue-derived stem cells (ADSCs) secrete several growth hormones that help cells develop and proliferate. According to laboratory and experimental studies, growth factors such as hepatocyte growth factor (HGF), vascular endothelial growth factor (VEGF), insulin-like growth factor (IGF) and platelet-derived growth factor (PDGF) increase the size of the hair follicle during hair development.

"Recent studies have shown that ADSCs promote hair growth in both men and women with alopecia. However, no randomized, placebo-controlled trial in humans has explored the effects and safety of adipose-derived stem cell constituent extract (ADSC-CE) in AGA. We aimed to assess the efficacy and tolerability of ADSC-CE in middle-aged patients with AGA in our study, hypothesizing that it is an effective and safe treatment agent," said Sang Yeoup Lee, M.D., Ph.D., of the Family Medicine Clinic and Research Institute of Convergence of Biomedical Science and Technology, Pusan National University Yangsan Hospital in South Korea. He led the group of researchers, which also included colleagues from Pusan National University School of Medicine, Pusan National University Yangsan Hospital and T-Stem Co., Ltd.

The team recruited 38 patients (29 men and nine women) with AGA and assigned half to an intervention group that received the ADSC-CE topical solution and half as a control group that received a placebo. Twice daily, each patient applied the ADSC-CE topical solution or placebo to their scalp using their fingers.

"At the end of 16 weeks, the group that received the ADSC-CEs had a significant increase in both hair count and follicle diameter," reported the study's senior author, Young Jin Tak, M.D., Ph.D.

Dr. Lee added, "Our findings suggest that the application of the ADSC-CE topical solution has enormous potential as an alternative therapeutic strategy for hair regrowth in patients with AGA, by increasing both hair density and thickness while maintaining adequate treatment safety. The next step should be to conduct similar studies with large and diverse populations in order to confirm the beneficial effects of ADSC-CE on hair growth and elucidate the mechanisms responsible for the action of ADSC-CE in humans."

"For the millions of people who suffer from male-pattern baldness, this small clinical trial offers hope of a future treatment for hair regrowth," said Anthony Atala, M.D., Editor-in-Chief of STEM CELLS Translational Medicine and director of the Wake Forest Institute for Regenerative Medicine. "The topical solution created from proteins secreted by stem cells found in fat tissue proves to be both safe and effective. We look forward to further findings that support this work."
-end-
The full article, "A Randomized, Double-blind, Vehicle-Controlled Clinical Study of Hair Regeneration Using Adipose-Derived Stem Cell Constituent Extract in Androgenetic Alopecia," can be accessed at https://stemcellsjournals.onlinelibrary.wiley.com/doi/abs/10.1002/sctm.19-0410.

About STEM CELLS Translational Medicine: STEM CELLS Translational Medicine (SCTM), co-published by AlphaMed Press and Wiley, is a monthly peer-reviewed publication dedicated to significantly advancing the clinical utilization of stem cell molecular and cellular biology. By bridging stem cell research and clinical trials, SCTM will help move applications of these critical investigations closer to accepted best practices. SCTM is the official journal partner of Regenerative Medicine Foundation.

About AlphaMed Press: Established in 1983, AlphaMed Press with offices in Durham, NC, San Francisco, CA, and Belfast, Northern Ireland, publishes two other internationally renowned peer-reviewed journals: STEM CELLS®, celebrating its 38th year, is the world's first journal devoted to this fast paced field of research. The Oncologist®, also a monthly peer-reviewed publication, entering its 25th year, is devoted to community and hospital-based oncologists and physicians entrusted with cancer patient care. All three journals are premier periodicals with globally recognized editorial boards dedicated to advancing knowledge and education in their focused disciplines.

About Wiley: Wiley, a global company, helps people and organizations develop the skills and knowledge they need to succeed. Our online scientific, technical, medical and scholarly journals, combined with our digital learning, assessment and certification solutions, help universities, learned societies, businesses, governments and individuals increase the academic and professional impact of their work. For more than 200 years, we have delivered consistent performance to our stakeholders. The company's website can be accessed at http://www.wiley.com.

About Regenerative Medicine Foundation (RMF): The non-profit Regenerative Medicine Foundation fosters strategic collaborations to accelerate the development of regenerative medicine to improve health and deliver cures. RMF pursues its mission by producing its flagship World Stem Cell Summit, honouring leaders through the Stem Cell and Regenerative Medicine Action Awards, and promoting educational initiatives.

AlphaMed Press

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