Clinical trial to study the effects of Stemedica’s proprietary mesenchymal stem cells in patients with traumatic brain injury.
SAN DIEGO, California; May 18, 2016 — Stemedica Cell Technologies, Inc. (Stemedica) received an FDA investigational new drug (IND) approval for a United States-based, Phase IIa clinical study using its ischemic tolerant, adult allogeneic mesenchymal stem-cells (itMSC) to treat subjects with traumatic brain injury (TBI). The study is sponsored by Stemedica with ProMedica Health Care Systems of Toledo, Ohio serving as both the trial site and a co-financial supporter of the trial. The clinical trial is titled “A Phase IIa, Open-Label Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Human Mesenchymal Stem Cells to Subjects with Moderate Traumatic Brain Injury.”
“Stemedica has achieved another milestone by expanding its clinical program in the United States to six major medical indications under IND approval including ischemic stroke, acute myocardial infarction, chronic heart failure, photoaging skin, Alzheimer’s disease and now traumatic brain injury,” said Lev Verkh, Ph.D., Stemedica’s Chief Regulatory & Clinical Development Officer. “We are investigating several medical indications we believe are best suited for our ischemic tolerant mesenchymal stem cells while collecting important safety and preliminary efficacy data on the effects of our stem cells. Our goal is to provide medical options to patients with our product.” [Read more…]