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This Phase II clinical trial of ProCord sponsored by Proneuron Biotechnologies, Inc. is a randomized-controlled study involving patients with acute complete spinal cord injury who meet study criteria. Following most types of tissue injury, white blood cells called macrophages quickly start to remove cell debris. These macrophages then secrete growth factors that help begin the healing process and promote regeneration. While this process occurs effectively in most tissues including peripheral nerves, it does not occur effectively in the spinal cord.

However, discoveries in pre-clinical trials by Prof. Michal Schwartz of Israel's Weizmann Institute of Science suggest that specially treated macrophages promote recovery from spinal cord injury. Based on these findings, Proneuron is evaluating the safety and efficacy of ProCord in human trials. ProCord consists of macrophages isolated from the patient's own blood, activated through Proneuron's process, and then injected directly into the patient's injured spinal cord.

	Dr. Robert Heary
	Dr. Karen Kepler

Dr. Robert Heary, associate professor of neurological surgery and director of the Spine Center at the New Jersey Medical School, and Dr. Karen Kepler, assistant professor of physical medicine and rehabilitation and director of the spinal cord injury program at NJMS, are the principal co-investigators of the study at University Hospital. Also participating in the study is the Kessler Institute for Rehabilitation where participants will receive post-procedure rehabilitation.

The ProCord procedure begins by taking the patient to the operating room for blood and skin sampling, typically from the upper arm. Autologous macrophages (the patient’s own white blood cells) within the blood sample are treated using Proneuron’s proprietary technology in a specially designed cell center (Progenitor Cell Therapy, LLC , located in Hackensack, NJ). This process takes approximately 36 hours to complete. The specially treated macrophage cells are then implanted into the patient’s spinal cord during a surgical procedure that involves exposure of the spinal cord followed by six injections directly below the area of the injury.

This experimental study is open to patients who meet eligibility criteria, including but not limited to ASIA Grade A, motor level C5 to neurological level 11, within 14 days of injury. This is a randomized-controlled clinical trial. Patients found eligible for the study will be randomly assigned to either a treatment or control group, two treatment patients for every one control patient, on average. Control patients will not receive the procedure. All control and treatment patients will receive standard spinal cord injury rehabilitation at Kessler Institute for Rehabilitation and will receive follow-up testing for one year. Trial site investigators need to be notified of a potential candidate within a few days of his or her spinal cord injury in order to give ample time for patients to be evaluated and potentially participate in the 14-day window of the clinical trial.

Physicians, patients, and immediate families may contact the study coordinator at University Hospital at 973-641-0600, 24 hours a day or Proneuron’s Patient Recruitment Center at 1-866-539-0767.

Other treatment sites in the study include: Mount Sinai Medical Center in New York, Craig Hospital in Denver, Colorado, Shriners Hospital for Children in Pennsylvania, and Sheba Medical Center in Israel. Shepherd Center in Atlanta, GA, anticipated to become treatment site before in early 2005, is already taking an active role in the study as a referral and rehabilitation center.

More information on the study, including eligibility and exclusion criteria, can be found at ProCord’s website: www.spinalcordtrial.com.

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