SAN DIEGO, April 22, 2016 /PRNewswire/ -- Kerastem Technologies today announced that its U.S. FDA approved Phase II STYLE trial, for male and female pattern baldness, has enrolled and treated its 21st patient (30% of target enrollment). In addition, as per the trial protocol, an independent data monitoring committee has reviewed safety data from the initial 10 patients and recommended that the study continue as planned. The 21 procedures performed at 4 trial sites in the United States, included fat harvest from small volume liposuction and scalp injections, were all completed successfully and well tolerated.
“We are very pleased by the study progress and the commitment of our study centers to the STYLE trial. In addition, we are encouraged that we have been able to demonstrate that same day fat harvest, cell processing and scalp injection is feasible and has been performed safely in multiple U.S. centers,” said Dr. Eric Daniels, Chief Medical Officer, Kerastem Technologies.
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. The trial is expected to completed enrollment later this year.
Details of the STYLE trial can be found at:
https://clinicaltrials.gov/ct2/show/NCT02503852?term=Kerastem&rank=1
Outside of the United States, the company is actively involved in market development, with Kerastem therapy currently being offered at a number of clinics in Europe & Japan. To learn more about Kerastem or the STYLE Clinical Trial, please visit www.kerastem.com.
About Kerastem Technologies, LLC
Kerastem Technologies, LLC is a leader in the development and commercialization of cell-based approaches to hair loss. The private company is a wholly owned subsidiary of Bimini Technologies and holds global rights to commercialize Cytori Therapeutics, Inc.'s (CYTX) Celution® Technology for the hair field of use. The Bimini portfolio also includes Puregraft, the world’s leading fat grafting solution.
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SOURCE Kerastem
