Thursday, June 28, 2007

Clinical Trial Suggests Bone Marrow Stem Cells Are Useful for Spinal Cord Injury

Patients Experienced Increased Mobility After Treatment; Preliminary Results Involving 25 Patients Presented at International Society for Cellular Therapy?s Annual Meeting in Sydney

PrimeCell? Therapeutics LLC announced that it provided research support and pre-clinical studies for a clinical trial to assess the safety, feasibility and efficacy of implanting autologous bone marrow stem cells into spinal cord injury (SCI) patients.

Dr. Luis Geffner presented a preliminary report at the 13th Annual Meeting of the International Society for Cellular Therapy, held here June 24-27. From May 2006 to January 2007, 25 patients with SCI were treated at Luis Vernaza Hospital in Guayaquil, Ecuador. They were treated with autologous bone marrow stem cells ? meaning the cells were extracted from the patients' own bone marrow.

Fifteen patients (60 percent) could stand up, ten patients (40 percent) could walk on the parallels with braces, seven (28 percent) could walk without braces, and four (16 percent) could walk with crutches. Patients demonstrated improvements in sensitivity, motility, bladder sensation, even controlling sphincters, erection and ejaculation. No adverse event was observed.

"These preliminary results, while encouraging, must be interpreted cautiously and prudently, and we must continue work examining the benefits of surgically implanted autologous bone marrow stem cells to patients with spinal cord injuries," said Geffner, director of the stem cell program at the Junta de Beneficencia de Guayaquil. He emphasized that this work was done with the help and support of the Junta de Beneficencia, Benemerita Sociedad de Lucha Contra el Cancer (SOLCA), and with the research support and pre-clinical studies performed by stem cell biologist and senior author Francisco Silva and his team at PrimeCell Therapeutics, based in Irvine, Calif.

The study included in vitro (laboratory tests), pre-clinical (animal) and clinical (human) data.

"There is evidence demonstrating significant improvement in the quality of life of patients receiving the treatment, including spinal cord regeneration and additional clinical improvements following these stem cell transplants,? said Silva, vice president of research and development for PrimeCell Therapeutics. ?More research is needed, of course, but this is very encouraging. Our ultimate goal, as always, is not just research ? but research that will lead to timely viable therapies."

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