Michael Levy, MD, PhD, FACS Chief of Pediatric Neurosurgery at Children’s Hospital San Diego (CHSD) and Professor of Neurological Surgery at the University of California, San Diego is the principal investigator of the study. Dr. Levy looks forward to enrolling patients, and reinforces the importance of clinical stem cell research. “This is an important step forward in translational medicine. This study may help pave the way for a new therapeutic category of treatment for ischemic stroke.”
Lev Verkh, PhD, Stemedica’s Chief Regulatory and Clinical Development Officer, commented, “We are pleased and delighted to be working with UCSD and Dr. Levy. We believe that progressing rapidly down the regulatory pathway may eventually provide treatment options for the 800,000 Americans who suffer a stroke each year.” According to the American Heart Association, stroke is the fourth leading cause of death, costing an estimated $73.7 billion in 2010 for stroke-related medical cost and disability.
The safety of stem cell treatment is of paramount concern to all stake holders in this emerging industry. Nikolai Tankovich, MD, PhD, President of Stemedica, highlights the Company’s relentless attention to this area. “As a cGMP government-licensed manufacturer of adult stem cells, we have also received an investigational new drug (IND) approval from the FDA for this clinical trial. Very few companies have this unique dual capacity. Our cells have gone through rigorous testing to make certain they are free from infectious agents and are not tumorigenic.”
Maynard Howe, PhD, Vice Chairman and CEO of Stemedica notes, “The medical and scientific community has much work to do in the prevention and treatment of stroke. Too many patients and family members have to cope with the aftermath of this disease. It is our hope that stem cell treatment may eventually ease the burden faced by patients and caregivers as well as curtail the extensive healthcare and rehabilitation costs.”
Source: Stemedica Cell Technologies, Inc