- Mié Jul 29, 2015 4:55 pm
#480155
Kerastem recibe la aprobación condicional de la FDA
La Terapia de pelo Kerastem es marca CE aprobado para pacientes con alopecia (caída del cabello) fuera de los Estados Unidos.
http://kerastem.com/
SAN DIEGO, July 28, 2015 /PRNewswire/ -- Kerastem Technologies announce that the Company has received notice of conditional approval from the U.S. FDA Center For Biologics Evaluation and Research (CBER) Office of Cellular, Tissue and Gene Therapies to conduct a clinical trial investigating the safety and feasibility of the Company's technology for the treatment of female and early male pattern baldness (androgenic alopecia).
The phase II study, known as the STYLE trial, follows initial clinical work in Europe and Japan. This clinical experience served as a basis for the FDA IDE submission. The data will be presented in September at the 2015 International Society of Hair Restoration Surgery meeting in Chicago. STYLE is a 70 patient controlled trial that is expected to begin enrollment in late 2015 at up to eight (8) centers within the United States. The primary endpoint is safety and tolerability of the treatment and secondary endpoints include change in hair growth and density.
La Terapia de pelo Kerastem es marca CE aprobado para pacientes con alopecia (caída del cabello) fuera de los Estados Unidos.
http://kerastem.com/
SAN DIEGO, July 28, 2015 /PRNewswire/ -- Kerastem Technologies announce that the Company has received notice of conditional approval from the U.S. FDA Center For Biologics Evaluation and Research (CBER) Office of Cellular, Tissue and Gene Therapies to conduct a clinical trial investigating the safety and feasibility of the Company's technology for the treatment of female and early male pattern baldness (androgenic alopecia).
The phase II study, known as the STYLE trial, follows initial clinical work in Europe and Japan. This clinical experience served as a basis for the FDA IDE submission. The data will be presented in September at the 2015 International Society of Hair Restoration Surgery meeting in Chicago. STYLE is a 70 patient controlled trial that is expected to begin enrollment in late 2015 at up to eight (8) centers within the United States. The primary endpoint is safety and tolerability of the treatment and secondary endpoints include change in hair growth and density.
