Stemedica Cell Technologies, Inc. (Stemedica), a world leader in stem cell research and manufacturing, announced that it completed its pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding a proposed IND (Investigative New Drug) to evaluate the safety and efficacy of Stemedica's high potency proprietary allogeneic mesenchymal bone marrow-derived stem cells (adult human) as a treatment for ischemic stroke. Based on a meeting October 13, 2009 with the FDA, Stemedica is planning to file an IND application in the first quarter of 2010.
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 a clinical diagnosis of chronic neurological or age-related neurodegenerative disease with significant functional or neurologic impairment 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.
"This is an important milestone for Stemedica," 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 can now establish our own clinical trial pathways for our various products. Stemedica's goal is to receive regulatory approvals for the clinical application of all of its products."
"With constructive feedback from the FDA we can work on fine-tuning the proposed treatment protocol and advance our proposed clinical trial to targeted medical facilities for full consideration," said Michael Levy, MD, PhD. Dr. Levy is the Chief of Pediatric Neurosurgery, Rady Children's Hospital of San Diego, Professor of Surgery, UCSD School of Medicine and the Principal Investigator for the proposed clinical trial.
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.
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