A clinical trial designed to test a stem cell-based treatment for female and male patterned baldness genetic alopecia achieved good results, according to Kerastem, the company that produces the therapy. The researchers say the treatment might potentially be used to treat other causes of hair loss, such as that resulting from cancer treatments, too.
David Perez-Meza, MD, clinical director of Ziering Medical Spain, presented the study findings at the 2015 International Society of Hair Restoration Surgery Annual Scientific Meeting in Chicago in September. The data was based on an initial clinical series from the United Kingdom in which the researchers performed a single scalp injection of Kerastem's regenerative cell-enriched adipose (fat) tissue in nine healthy hair loss patients. Six of the patients were followed for a period of six months using global photography and macrophotography with the Handyscope and Trichoscale Pro software used to quantify hair growth.
The research team reported a 100 percent patient response rate to the Kerastem Therapy at six months. In patients with early stage hair loss, the percentage increase in hair count/density was a mean difference of 17 percent. In males with early grade loss, an average 29 percent increase in hair count/hair density with a mean difference of 40 hairs per square centimeter was observed. The trial is approved to move to the United States next, involving as many as 70 patients at up to eight centers. Enrollment is expected to begin by the end of 2015 and continue into 2016.
The Kerastem Therapy is based on the emerging science that adipose (fat) plays an important role in the normal hair follicle growth cycle. The clinical approach utilizes purified adipose combined with stem and regenerative cells to deliver cell enriched tissue to the affected scalp. According to Dr. Eric Daniels, Chief Medical Officer of Kerastem, "Fat and fat derived stem cells are becoming increasingly recognized as a vital participant in the normal cycle of hair growth. This data set from the United Kingdom supports this assertion and we look forward to the launch of our STYLE clinical trial in the United States." STYLE is Kerastem's phase II randomized, blinded, and controlled investigation of Kerastem Therapy in early stage female and male pattern baldness. STYLE is approved to enroll up to 70 patients at up to eight (8) centers within the United States and is expected to continue enrollment into 2016.
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