HEALTH SCAN: Physician, calm thyself!
October 5, 2003

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CORD TREATMENT TRIALS

Israelis who suffer spinal cord injury will be given treatment within 14 days of the accident as part of phase II clinical trials at Sheba Medical Center at Tel Hashomer. The study will include 61 patients between the ages of 16 and 65, all with complete spinal cord injury (SCI).

Proneuron Biotechnologies, a leader in the development of treatments for such injuries and other disorders of the central nervous system, has announced testing of ProCord. This treatment, developed by Prof. Michal Schwartz of the Weizmann Institute of Science, is described as autologous activated macrophage therapy for the treatment of patients with acute SCI. Macrophages isolated from the patient's own blood are activated through a proprietary process and then injected directly into the injured spinal cord.

Following tissue injury, a type of white blood cell called a macrophage is quickly mobilized and starts to remove cell debris. Macrophages then begin to secrete growth factors that promote a controlled inflammatory reaction - the initial phase of the wound-healing process. While this process normally occurs in most tissues, including peripheral nerves, it does not occur in the central nervous system, including the spinal cord. Schwartz has shown that specially treated macrophages promote recovery from SCI. Based on these findings, Proneuron is developing ProCord as a clinical product to treat spinal cord injured patients.

Schwartz's work has greatly interested Christopher Reeve, the "Superman" actor who became a quadriplegic when a horse threw him eight years ago, even though he is not suitable for the treatment.

Sheba is the first of five locations to host the study; others that have already received US Food and Drug Administration approval are Craig Hospital in Denver, Mount Sinai Hospital in New York and the Kessler Institute for Rehabilitation in West Orange, New Jersey.

Phase I studies in Israel and Belgium showed positive results in an encouraging number of patients; from complete loss of feeling and movement to recovery of some feeling and movement below the level of injury.

"We hope that this trial will lead to additional positive results that will ultimately enable us to offer a valuable treatment," said Dr. Nachshon Knoller, principal investigator at Sheba. In the US alone, there are an estimated 11,000 new spinal cord injuries per year. Causes include car accidents, acts of violence and falls.