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barbara
03-17-2009, 04:13 PM
Article Date: 16 Mar 2009


DaVinci Biosciences, in collaboration with Luis Vernaza Hospital in Ecuador, announced today the publication of study results demonstrating the safety and feasibility of its acute and chronic spinal cord injury treatment platform in issue 17(12) of Cell Transplantation, a peer-reviewed journal focused on regenerative medicine. The study demonstrates that administering adult autologous bone marrow derived stem cells via multiple routes is feasible, safe, and most importantly, improves the quality of life for both acute and chronic spinal cord injury (SCI) patients.

The study documents eight patients (four acute and four chronic) who were administered autologous bone marrow derived stem cells using a multiple route delivery technique. A two-year follow-up was performed on all the patients in the study who received the treatment. Using sequential MRIs, the follow-up demonstrated noticeable morphological changes within the spinal cord after administration of autologous bone marrow derived stem cells. Participating spinal cord injury patients experienced varying degrees of improvement in their quality of life, such as increased bladder control, regained mobility and sensation. Most importantly, the study demonstrated no adverse effects such as tumor formation, increased pain, and/or deterioration of function following administration of autologous bone marrow derived stem cells. In a video provided by the Luis Vernaza Hospital, patients involved in the study can be seen discussing their improved quality of life at: http://bit.ly/DavinciStemCellStudy.

Up to 400,000 people in the United States are estimated to live with spinal cord injuries, according to the Christopher and Dana Reeve Foundation. On January 23, 2009, The Food and Drug Administration approved the first U.S. clinical trial to use human embryonic stem cells in paralyzed humans. In a recent ABC News story on this FDA approval, Dr. Sean Morrison, director at the University of Michigan Center for Stem Cell Biology was cited as saying that even if this study could restore partial spinal cord function or bladder function that it would be a really important advancement. The study published by DaVinci Biosciences and Luis Vernaza Hospital in Cell Transplantation, which used stem cells derived from the patient's own bone marrow, documents the restoration of significant movement, sensation, and bladder function in patients suffering from a spinal cord injury.

"This collaborative study with the Luis Vernaza Hospital is a significant milestone for patients suffering from spinal cord injury," said Dr. Rafael Gonzalez, Director of Research and Development 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."

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

"Although there have been numerous studies in animals demonstrating the benefits of stem cell treatment for the treatment of 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," said Dr. Paul Sanberg, Director of the Center of Excellence for Aging and Brain Repair at the University of South Florida. A survey of spinal cord injury patients conducted in 2004 illustrates that one of the most important aspects in improving their quality of life would be the ability to control bladder function. Patients involved in DaVinci Biosciences' study regained partial or full bladder function, bladder sensation and/or the active ability to void.

DaVinci Biosciences is currently developing cell-based therapeutics and small molecule compounds for the treatment and cure of paralysis caused by spinal cord injury, amyotrophic lateral sclerosis (ALS) and other human degenerative disorders. In tandem with the Company's advances in cell-based and small molecule therapies, DaVinci Biosciences along with its collaborator has patented a surgical technique for the effective delivery of therapies directly into the spinal cord.