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Kerastem is an autologous cell therapy developed by Kerastem Technologies (a subsidiary of Bimini Health Tech) for the treatment of androgenetic alopecia (male and female pattern hair loss). The procedure involves harvesting a patient's own adipose tissue via liposuction, which is then processed using the Puregraft System for purification and the Celution System to isolate adipose-derived regenerative cells (ADRCs). These ADRCs are then used to enrich the purified fat, which is injected into the scalp as a one-time treatment. The therapy aims to regenerate the hair follicle niche by restoring the stem cell and fat-rich environment necessary for healthy hair growth. Clinical data from the Phase II STYLE trial showed significant increases in terminal hair counts in men with early-stage hair loss. While Kerastem is CE mark approved in Europe and offered in several international markets, it is currently in Phase II development in the United States and is not FDA-approved.
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