STEMEDICA RECEIVES APPROVAL FROM UCSD TO INITIATE ISCHEMIC STROKE STUDY WITH ADULT ALLOGENEIC STEM CELLS
Know anyone with a stroke? Adult Stem Cells Work!!!
~ Uncle Russ
(Source: February 17, 2011; Stemedica Cell Technologies, Inc.)
Stemedica Cell Technologies, Inc., a leader in adult allogeneic stem cell manufacturing, research and development announced today that it has received IRB approval from the University of California, San Diego (UCSD) to initiate a Stemedica clinical study entitled, “A Phase I/II, Multi-Center, Open-Label Study to Assess the Safety, Tolerability and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Mesenchymal Bone Marrow Cells to Subjects With Ischemic Stroke”. This study will enroll approximately 35 subjects with a clinical diagnosis of ischemic stroke. These patients have significant functional or neurologic impairment that confines them to a wheelchair or requires home nursing care or assistance with the general activities of daily living and have received the ischemic stroke diagnosis at least six months prior to enrollment in this study.
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.”
Information on enrolling in the study can be found at http://clinicaltrials.gov/ct2/results?term=stemedica.
About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies Inc. is a specialty biopharmaceutical company that is committed to the manufacturing and development of best-in-class allogeneic adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and clinical (human) trials. The company is a government licensed manufacturer of clinical grade stem cells and is approved by the FDA for its clinical trials for ischemic stroke. Stemedica is currently developing regulatory pathways for a number of medical indications using adult allogeneic stem cells. The Company is headquartered in San Diego, California.