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Spinal Cord Injuries Treated With Adult Stem Cells

Cell Transplantation, March 28, 2009

Researchers have published the results of a study demonstrating both the safety and the feasibility of an adult stem cell therapy for the treatment of both acute and chronic spinal cord injuries.

Scientists at the California-based company, DaVinci Biosciences, in collaboration with the Luis Vernaza Hospital in Ecuador, have conducted a clinical study in which 8 patients were treated with autologous (in which the donor and recipient are the same person) adult stem cells derived from each patient's own bone marrow. The stem cells were then administered via a proprietary "multiple route delivery technique" to the 8 patients, 4 of whom suffered from acute spinal cord injuries and 4 of whom suffered from chronic spinal cord injuries. The routes of administration included delivery directly into the spinal cord, directly into the spinal canal and intravenously. Throughout the 2-year follow-up period, all 8 patients were observed to improve through the measurement of such parameters as regained mobility and sensation, regained bladder control and confirmation by sequential MRIs of actual morphological regeneration within the spinal cord itself. No adverse side effects were observed.

Approximately 400,000 people in the U.S. alone are estimated to suffer from spinal cord injuries, with approximately 11,000 new cases diagnosed each year. On average, 52% of all spinal cord injuries result in paraplegia while around 47% result in quadriplegia. According to Dr. Rafael Gonzalez, director of R&D for DaVinci Biosciences, "We are pleased to see the publication of our research. It represents a giant step in the process of improving the quality of life in people living with spinal cord injury and other neurodegenerative disorders."

According to Francisco Silva, president of DaVinci Biosciences, "The outcome of this study is exciting for us and our patients. We plan on expanding and building upon the results. We strongly believe that this is an important first step for realizing the therapeutic application of stem cells for treating diseases and injuries such as spinal cord injury in humans."

As Dr. Paul Sanberg, director of the Center of Excellence for Aging and Brain Repair at the University of South Florida, adds, "Although there have been numerous studies in animals demonstrating the benefits of stem cell treatment for spinal cord injury, this is the first published study of its kind. It gives patients the possibility that their quality of life can be improved."

Headquartered in Costa Mesa, California, DaVinci Biosciences has additional facilities throughout North and South America and is involved in a number of parnerships with universities, medical research institutions and hospitals. DaVinci's primary area of development is focused on cell-based therapeutics and small molecule compounds in the treatment of neurodegenerative disorders such as spinal cord injury, multiple sclerosis, Parkinson's disease, and ALS (amyotrophic lateral sclerosis, also known as Lou Gehrig's disease). In collaboration with one of its partners, the company has patented a surgical technique for the effective delivery of cell-based therapies directly into the spinal cord. DaVinci Biosciences is divided into 2 main business units which include DV Biologics, the main research division, and DV Therapeutics, the development division which advances the molecular and cell-based technologies to therapeutic applications.

In the exploding field of regenerative medicine, this new study provides strong evidence that autologous adult stem cells derived from bone marrow offer a safe and feasible therapy which improves the quality of life for patients suffering from acute and chronic spinal cord injury.



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