Clinical Trials Update . .
September 2000

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Proneuron Biotechnologies (Ness-Ziona, I study to assess the safety of autologous activated macrophage therapy in the treatment of patients with complete spinal cord injury. The study, conducted in Israel under an FDA New Drug Application and with the approval of the Israel Ministry of Health, is designed to study approximately eight complete spinal cord injury patients and to follow their post-treatment course for one year or longer.

The use of autologous activated macrophages for nerve regeneration is based on technology developed in the laboratory of Prof. Michal Schwartz of the Weizmann Institute of Science in Israel. The technology is currently licensed to Proneuron.

Prof. Schwartz and her team study the role of immunity within the central nervous system in the development of neurological disorders. Her research has demonstrated significant recovery of neurological function in animal models of spinal cord injury by activating and administering macrophages, according to Proneuron.

The strategy employed in the present trial is to induce nerve regeneration by enhancing the natural macrophage response in injured spinal cord tissue by directly implanting activated autologous cells. If the positive results of extensive animal experiments can be repeated in humans, the use of this therapeutic approach would be of significant clinical value, even if only partial recovery can be achieved, Proneuron maintains.