Date:3/12/2009

Patients Suffering from Acute and Chronic Spinal Cord Injury Regain Sensation, Motor Functions and Bladder Control According to a Safety and Feasibility Study Published Today in Cell Transplantation

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."
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