World News: 21:30 GMT Wednesday 11th July 2018. [Osiris Therapeutics, Inc. via Globe Newswire via SPi World News]
COLUMBIA, Md., July 11, 2018 (GLOBE NEWSWIRE) -- (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 cm and 25 cm. 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.
Osiris Therapeutics is partnering with CPC Clinical Research, an Academic Clinical Research Organization (ARO), who will be responsible for clinical site monitoring, all data management, and pharmacovigilance and biostatistical services.
The study protocol has been designed using the FDA guidelines for Industry clinical trials for products used to treat burns and cutaneous ulcers (Guidance for Industry, 2006). The primary efficacy endpoint of the study is complete ulcer closure by week 12. The primary endpoint will undergo confirmation by blinded evaluators at the Wound Core Lab at CPC Clinical Research.
Diane SavoieOsiris Therapeutics, Inc.(443) 545-1834
Globe Newswire: 21:30 GMT Wednesday 11th July 2018
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