Kerastem Completes Enrollment in US Phase II Hair Growth Trial
70 Patients Enrolled & Successfully Treated Ahead of Schedule
SAN DIEGO, Sept. 23, 2016 — Kerastem, the leader in cell therapy-based approaches to addressing hair loss, has completed enrollment of STYLE, the company’s US Phase II Clinical Trial. STYLE is Kerastem’s phase II randomized, blinded, and controlled investigation of Kerastem therapy in early stage female and male pattern baldness. The Kerastem therapy is a combination of fat based stem and regenerative cells and fat tissue purified with Puregraft, the market leading fat transfer solution.
A total of four clinical trial sites treated a target enrollment of 70 patients. The primary endpoint of STYLE is safety and tolerability at six months and subjects will be followed for 12 months. Subjects participating in STYLE received one of four treatment arms, including fat plus fat derived stem and regenerative cells.
“Successfully completing enrollment of STYLE is a foundational step towards Kerastem’s goal to be the first U.S. FDA approved stem and regenerative cell therapy to treat hair loss. STYLE target enrollment has been completed ahead of schedule,” explained Brad Conlan, CEO of Kerastem. Hair loss affects more than 21 million women and 40 million men in the United Statesalone. The global hair loss market is valued at more than $7 Billion and currently has limited options for women and men with early hair loss.1
“We are extremely pleased by STYLE’s progress and this is reflective of the significant interest and commitment of participating subjects and investigators, said Ken Washenik, M.D., Ph.D, Principal Investigator. “In addition, we are encouraged that we have been able to demonstrate that same day adipose (fat) harvest, cell processing and scalp treatment is feasible and readily performed in a number of distinct practice environments throughout the U.S.”
Kerastem is the leader in the development and commercialization of cell therapy-based approaches to hair loss. The private company is a wholly-owned subsidiary of Bimini Technologies. Outside of the U.S., the company is actively involved in market development; Kerastem therapy is currently being offered at a number of clinics in Europe and Japan. To learn more about Kerastem or the STYLE Clinical Trial, please log onto www.kerastem.com. The Bimini portfolio also includes Puregraft (www.puregraft.com), the world’s leading fat transfer solution.
1 Source: IBISworld Report OD4136: Hair Loss Treatment Manufacturing in the US