Phase I ProCord Study Results Published in the Journal of Neurosurgery: Spine, September 2005 Issue; ProCord Phase I Study Results Suggest Evidence of Safety

9/12/2005 11:10:00 AM EST



Proneuron Biotechnologies (www.proneuron.com) announced today the publication of the results of the first ProCord study in the September issue of the Journal of Neurosurgery: Spine in an article titled Clinical Experience using Autologous Incubated Macrophages as a Treatment for Complete Spinal Cord Injury-Phase I Study Results. Journal subscribers can access the article on-line at www.thejns-net.org.

The FDA-sanctioned study was an uncontrolled, Phase I clinical trial designed to assess the safety and tolerability of ProCord (autologous incubated macrophages), an experimental immune cell therapy. The article documents the results of eight acute spinal cord injury patients treated at Chaim Sheba Medical Center Israel, and followed for a year thereafter. ProCord proved to be well tolerated, with no observed side-effects. Preliminary efficacy results were also generated.

Patients were enrolled in the study within 14 days of their injury, and were evaluated accordingly with the American Spinal Injury Association (ASIA) scale. All eight were assessed as ASIA A, meaning complete loss of feeling and movement below the point of injury. Three of these patients recovered some feeling (ASIA B); and went on to recover limited movement below the level of injury (ASIA C).

"Overall, the study ... represents a small, although potentially promising Phase I safety study. Although the conversion from ASIA A to C status in three patients is encouraging, one needs to exercise caution when interpreting the results obtained in an unblinded pilot study. Nonetheless, it is encouraging that the patients appeared to tolerate the treatment well without evidence of neurological deterioration," wrote Michael G. Fehlings, MD, PhD, FRCSC in the editorial that precedes the article. Dr. Fehlings is a Professor of Neurosurgery, Krembil Chair in Neural Repair and Regeneration, McLaughlin Scholar in Molecular Medicine, University of Toronto, Chair, Spinal Cord Injury Committee, Section of Neurotrauma and Critical Care, American Association of Neurological Surgeons and Congress of Neurological Surgeons."

Besides the initial eight patients presented in this article, eight other patients have now been treated with ProCord, as part of a Phase I extension study and a Phase Ib study conducted in Belgium. The results of these additional studies further.......

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