Ossium Health Announces FDA Clearance of its Investigational New Drug Application for Treatment of Perianal Fistulizing Crohn’s Disease
16 Mar 2022
Crohn DiseaseOSSM-001Cell Therapy
Ossium Health, Inc., a clinical-stage bioengineering company developing cellular therapeutics to revolutionize treatment of blood, immune, and inflammatory diseases, announced today that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for OSSM-001, a mesenchymal stem cell (MSC) product, for the treatment of refractory perianal fistulas in patients with Crohn’s disease. Ossium plans to initiate patient screening and enrollment in a multi-center Phase 1 clinical trial evaluating OSSM-001 by the end of 2022.
“The FDA’s clearance of our OSSM-001 product to enter clinical trials is a major milestone in our development of advanced therapies that leverage Ossium’s proprietary manufacturing platform to treat patients with diseases of inflammation,” said Ossium’s Chief Executive Officer and Co-Founder, Kevin Caldwell. “OSSM-001 is the second Ossium cell therapy product to enter the clinic and the first of our MSC products to be used in patients. The initiation of this trial is a crucial step toward the development of a new treatment paradigm for patients with refractory perianal fistulas, which represent one of the most challenging manifestations of Crohn’s disease.”
This study is a double-blind, randomized, placebo-controlled Phase 1 trial to evaluate the safety and feasibility of a single dose of allogeneic bone marrow-derived MSCs at prespecified doses of 100 million or 300 million cells in adults with medically refractory perianal fistulizing Crohn’s disease. The primary endpoint of this study is product safety with secondary endpoints for fistula healing.
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