New TBI Drug Receives FDA Approval for Clinical Trial
A new stem cell drug recently received an FDA investigational new drug approval for a U.S.-based study.
According to a press release by Stemedica Cell Technologies, Inc., Stemedica received the approval for a Phase IIa clinical study using its ischemic tolerant, adult allogeneic mesenchymal stem-cells (itMSC) to treat subjects with traumatic brain injury(TBI).
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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.
Stemedica Cell Technologies, Inc. is a global biopharmaceutical company that manufactures allogeneic adult stem cells and stem cell factors.
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, PhD., 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.”
Stemedica’s bone marrow-derived, allogeneic itMSCs are unique because they are grown under conditions that more closely resemble the environment in which they live in the body. Compared to other MSCs, itMSCs secrete higher levels of growth factors usually associated with angiogenesis and healing.
According to the Centers for Disease Control and Prevention (CDC), causes of TBI include falls, motor vehicle crashes, colliding with a person or object and assault.
Symptoms of TBI include balance problems; double or blurry vision; sensitivity to light or noise; concentration or memory problems; and mood changes such as irritability, sadness, nervousness and anxiety.
“Stemedica is pleased to be advancing this clinical trial in the investigation of traumatic brain injury,” says Nikolai Tankovich, M.D., PhD., President and Chief Medical Officer of Stemedica. “As the number one cause of death and long-term disability in young people, the prolonged problems it is creating for our military veterans and the pronounced impact it is having on our sports heroes is substantial. Any role our stem cell product can play in aiding those suffering from TBI is worth researching. Along with our partner ProMedica, we are committed to determining the potential role stem cells can play in the treatment of traumatic brain injury.”
The Phase IIa clinical trial will enroll approximately 24 patients as part of its study population.
