Dr. David Snyder, Vice President of Clinical Development at Proneuron, answers questions about ProCord, an experimental procedure for complete spinal cord injury, and its Phase II clinical trial.
Proneuron (www.proneuron.com) developed the ProCord therapy based on the research of Professor Michal Schwartz of the Weizmann Institute of Science in Rehovot, Israel. The Alan T Brown Foundation to Cure Paralysis provided Prof. Schwartz with seed money for her initial research.
Q. What is ProCord?
Procord is the name that was chosen by Proneuron for the autologous incubated macrophage procedure.
Q. What are macrophages?
Following tissue injury, a type of white blood cell, called a macrophage, quickly starts to remove cell debris. These macrophages then start to secrete growth factors that promote a controlled inflammatory reaction to initiate the wound healing process. While this process occurs effectively in most tissues including peripheral nerves, it does not occur effectively in the central nervous system. Discoveries led by Prof. Michal Schwartz of the Weizmann Institute of Science have shown in pre-clinical studies that specially treated macrophages, however, promoted recovery from spinal cord injury (SCI). Based on these findings, Proneuron is now evaluating the safety and efficacy of ProCord, currently an expeimental procedure for patients with acute spinal cord injury.
Q. What is an autologous incubated macrophage?
Autologous incubated macrophages are macrophages, isolated from the patient’s own blood, activated through a proprietary process and then injected directly into the patient’s injured spinal cord at the site of the lesion. ProCord must be administered within 14 days of the injury to meet study criteria.
Q. What does the study and follow up include?
This is an international, multi-center, randomized-controlled, Phase II study. Patients will be randomly assigned to either a treatment or control group (two treatment patients for every one control patient). Control patients will not receive the ProCord procedure. There is no placebo procedure and no mock surgery. All patients, including those in the control group, will receive standard spinal cord injury rehabilitation and be followed for one year. Follow up will include general and neurological examinations and MRIs. The primary endpoint to assess efficacy is improvement in ASIA classification to grade ASIA B or better, essentially some degree of feeling and/or control of muscles.
Q. What hospitals are participating in the study of this experimental treatment?
Craig Hospital in Denver became the first hospital in the U.S. to participate in the trial. Mount Sinai Medical Center in New York and Kessler Institute for Rehabilitation in New Jersey opened for enrollment in June 2004; Shepherd Center in Georgia will begin enrolling before the end of 2004. The Chaim Sheba Medical Center in Israel was the first site to enroll patients in the ProCord study.
Q. Who is Proneuron?
Proneuron Biotechnologies Inc. is a privately held biopharmaceutical company developing products for the medical treatment of spinal cord injuries and other disorders of the central nervous system. Its products are based on proprietary technology for modulating the interaction between the nervous and immune systems. The company’s products are currently being evaluated in several clinical studies located in the U.S., Belgium and Israel.
To learn more about the study, please visit Proneuron at www.proneuron.com/clinicalstudies/index.html
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