BHI Therapeutic Sciences Inc. Notified by FDA that it can proceed with New Drug Clinical Trial for Acute Ischemic Stroke
BHI Therapeutic Sciences (BHITS), a leader in stem cell therapy and research utilizing human umbilical cord blood, announced today that the company has been notified by the Food and Drug Administration (FDA) that its Investigational New Drug (IND) application to allow for the initiation of a clinical study of an FDA-approved cell therapy (HCP, cord blood) for treatment of acute ischemic stroke may proceed.
Phase 1/2 Study entitled “Evaluation of the Safety and Efficacy of Hemacord HPC, Cord Blood in Subjects with Acute Ischemic Stroke” is a prospective, open-label, single-center, exploratory clinical study that is designed to characterize the safety and efficacy profile of HCP, cord blood, when administered by intravenous infusion and intrathecal injection, in 10 subjects who have sustained an acute ischemic stroke.
“Stroke is a leading cause of adult disability worldwide and the second highest cause of death in the world. To date, there are no clinically effective pharmacotherapies that can promote cellular functional recovery after an ischemic stroke. Human umbilical cord blood cell therapy is a promising treatment for ischemic stroke,” said Brian Mehling, M.D., chief medical officer of BHITS. “Stem cell therapy is an exciting, innovative method for the management and treatment of multiple medical conditions. We offer a unique concept that combines treatment and research,” he added.
BHITS will support other follow-on indications using umbilical cord derived stem cells for treatment of traumatic brain injury, including chronic traumatic encephalopathy. Chronic Traumatic Encephalopathy is a neurodegenerative disease that is found in people with multiple head injuries. It afflicts players in the National Football League. NFL players have committed suicide as a result of the disease. The NFL has set aside nearly $800 million to treat it, but there is currently no treatment. BHITS will also be approaching the NHL and their player’s union. BHITS intends to develop human umbilical cord-derived mesenchymal stem cell product based therapies for use in IND Phase 1 clinical trials in order to extend lifespans and improve the quality of life for patients.
In collaboration with local partners in Slovakia and China, BHITS’ sister company, Blue Horizon International has conducted several clinical investigations. Research subjects with chronic inflammation, musculoskeletal conditions, stroke and spinal cord injury were enrolled in our research studies and successfully treated with the application of human umbilical cord blood cells. In Slovakia, we are working on new clinical protocols (Parkinson’s disease, retinal and optic nerve diseases etc.) and planning to enroll research subjects in our existing and new research studies.
Dr. Mehling’s research has been published in both national and international scientific journals including International Journal of Medical, Health, Biomedical, Bioengineering, and Pharmaceutical Engineering and Stem Cell Research and Therapy.