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Proneuron’s Phase II Experimental ProCord Procedure for Complete Spinal Cord Injury Now Available at The Mount Sinai Medical Center in NY & University Hospital in collaboration with Kessler Institute for Rehabilitation in NJ
 

ProCord is an experimental procedure involving specially treated white
blood cells (macrophages) injected into the damaged spinal cord of a patient
 

Newark, NJ and NY, NY, December 7, 2004 --- Proneuron Biotechnologies (www.proneuron.com) announced today that The Mount Sinai Medical Center and University Hospital in collaboration with Kessler Institute for Rehabilitation are now enrolling patients as treatment sites in the Phase II study of ProCord for complete spinal cord injury. University Hospital patients will receive post-procedure rehabilitation at Kessler Institute for Rehabilitation in West Orange, NJ. Patients enrolled at the New York site will receive all procedures at The Mount Sinai Medical Center. Progenitor Cell Therapy, LLC (PCT, Hackensack, NJ) will provide the required cell processing facility for the manufacturing of ProCord for both sites. The Mount Sinai Medical Center and Kessler Institute for Rehabilitation became referral sites in June 2004.

“There are two classifications for sites participating in the ProCord study, treatment and referral. The Principal Investigators at the treatment sites are specifically trained and have been well prepared to surgically inject the experimental ProCord into a patient’s injured spinal cord. Treatment sites also either have a specially designed ProCord cell processing center in house or located reasonably close in proximity. Referral sites actively screen patients into the study and provide rehabilitation management for those referrals who have been accepted into the trial. Both are crucial functions to conducting a thorough and scientifically sound investigation. We are proud to be working with all of the esteemed sites in the ProCord study network,” said Dr. David Snyder, V.P. of Clinical Development at Proneuron.

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. Discoveries in pre-clinical trials by Professor Michal Schwartz of Israel's Weizmann Institute of Science suggest however 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 proprietary process, and then injected directly into the patient's injured spinal cord.

This international, multi-center, randomized-controlled, experimental study is open to patients who meet eligibility criteria, including but not limited to an ASIA Grade A injury between C5-T11 vertebrae, within 14 days of injury. ASIA Grade A is defined as patients who have no feeling or movement below the point of injury.

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 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.

Other treatment sites include: Craig Hospital in Denver, Colorado, Shriners Hospitals for Children, Philadelphia and Chaim Sheba Medical Center in Israel. Shepherd Center in Atlanta, GA, anticipated to become a treatment site in early 2005, is already taking an active role in the study as a referral and rehabilitation center. For a complete list of sites please visit: www.spinalcordtrial.com.

Patient, Immediate Family of Patient and/or Physician inquiries:
24 hour a day Patient Recruitment Center:
E-mail: clinical.trial@proneuron.com
Telephone: 1-866-539-0767 (U.S. toll free) or 1-506-652-3486.
Fax 1-866-214-7078
**Callers outside the U.S., please use standard international dialing code
For additional information: www.proneuron.com

For additional information:
Marjie Hadad, Media Liaison, Proneuron, Marjie.hadad@proneuron.com, +972-54-536-5220.

Debra Kaplan, Associate Director of External Relations, The Mount Sinai School of Medicine, 212-659-9045 or debra.kaplan@mssm.edu

Robin Preisler, Executive Director, Marketing and Media Relations, University Hospital, preislro@umdnj.edu,  (973)972-6273.

Gail Solomon, Director of Corporate Communications, Kessler Institute for Rehabilitation, 973-243-6879; pager 973-705-6813, or gsolomon@kessler-rehab.com

George S. Goldberger, Chief Business Officer, PCT, ggoldberger@progenitorcell.net or 201-883-5314.