eClinical Technology and Industy News

Stemedica Initiating Phase IIb/III Clinical Trial for Patients with Chronic Ischemic Stroke

Excerpt from the Press Release:

SAN DIEGO–(BUSINESS WIRE)–Stemedica Cell Technologies, a best-in-class manufacturer of ischemic tolerant, allogeneic mesenchymal stem cells (itMSC), announced today that it has initiated its “PHASE IIB/III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY, SAFETY, AND TOLERABILITY OF A SINGLE INTRAVENOUS INJECTION OF ALLOGENEIC MESENCHYMAL STEM CELLS TO SUBJECTS WITH ISCHEMIC STROKE” under an existing US IND using its itMSC product.

Stemedica plans to initiate a Phase IIb/III, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of a single intravenous injection of allogeneic mesenchymal stem cells to subjects with ischemic stroke. The primary objective of this study is to evaluate the efficacy of an IV injection of itMSCs for improvement in clinical outcomes of the upper-extremity portion of the body as measured on the Fugal-Meyer Scale in subjects with ischemic stroke at Day 0 through Month 6.

Secondary endpoints of the study include measuring change from the baseline in the modified Rankin Scale and Barthel Index, as well as the safety and tolerability of Stemedica’s itMSCs.

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