GrafixPL PRIME™ in the Treatment of Chronic Venous Leg Ulcers
COLUMBIA, Md., July 11, 2018 (GLOBE NEWSWIRE) — Osiris Therapeutics, Inc. (OTC Pink:OSIR), a regenerative medicine company focused on developing and marketing products for wound care, orthopedics, and sports medicine, announced the initiation of its “Multicenter, Prospective, Randomized, Open-Label Study with a Crossover Extension Option to Evaluate the Safety and Efficacy of GrafixPL PRIME™ in the Treatment of Chronic Venous Leg Ulcers.”
This study is expected to enroll up to 200 patients in approximately 30 clinical sites. Patients will be randomized 1:1 to receive GrafixPL PRIME plus standard compression therapy (SOC) versus SOC alone in patients with chronic venous leg ulcers (VLUs). The study objective is to evaluate the safety and efficacy of weekly applications of GrafixPL PRIME plus SOC versus SOC alone for chronic VLUs with a size between 1 cm2 and 25 cm2. Patients in the SOC alone group whose ulcers do not close will be offered GrafixPL PRIME adjunct to SOC in a crossover extension treatment phase of up to 12 treatments … read more