Stemedica, a leader in stem cell research and manufacturing, announced that it has filed an Investigative New Drug (IND) application with the FDA for a clinical trial. The trial will assess the safety, tolerability and efficacy of Stemedica's high potency proprietary allogeneic mesenchymal bone marrow-derived stem cells (adult human) as a treatment for ischemic stroke.
The proposed clinical trial will be a Phase I/II dose escalation and safety clinical trial using allogeneic mesenchymal bone marrow cells administered intravenously to patients with ischemic stroke. The patient population will include individuals with significant functional or neurologic impairment related to the ischemic stroke that confines the subject to a wheelchair or requires the subject to have home nursing care or assistance with the general activities of daily living. The proposed trial will take place at medical centers within the United States.
"Stemedica achieved another milestone in its development program by moving from research to patient bedside to help people suffering from stroke," said Nikolai Tankovich, MD, PhD, Stemedica's President and Chief Medical Officer.
"In addition to the official licensing of our manufacturing facility in San Diego, California, we have now established our own clinical trial pathway in compliance with FDA and FDB regulatory requirements. Stemedica's goal is to receive regulatory approval of our mesenchymal stem cells for this clinical indication." "We are happy that Michael Levy, MD, PhD, Chief of Pediatric Neurosurgery at Rady Children's Hospital of San Diego and Professor of Surgery at UCSD's School of Medicine, will be the Principal Investigator leading our clinical trial," said Maynard A. Howe, PhD, Vice Chairman and CEO, who added, "Stemedica is committed to developing, manufacturing and distributing adult stem cells that have the potential to save, restore and improve lives. This mission is central to everything that Stemedica does and we are dedicated to executing this mission with great passion and scientific discipline." Stemedica was granted its license by the State of California's Department of Public Health, Food and Drug Branch to manufacture stem cells for clinical trials in July, 2009. The Drug Manufacturing License grants Stemedica the right to manufacture clinical-grade (for human use) drug or biologic products and recognizes Stemedica as being compliant with California law and the applicable provisions of the Code of Federal Regulations.