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What is ProCord?

ProCord is the name that was chosen by Proneuron for the autologous incubated macrophage procedure.

What is the Phase II study?

The Phase II clinical trial is an international, multi-center, randomized-controlled study performed under the U.S. Food and Drug Administration's (FDA) regulations to test the safety and efficacy of the procedure in patients with acute complete spinal cord injuries. The official name of the study is "A Phase II, Multicenter, Randomized-Controlled Study to Evaluate the Safety and Efficacy of Autologous Incubated Macrophages for the Treatment of Patients with Spinal Cord Injuries." ProCord received FDA orphan drug designation status in September 2004.

Who can participate in the clinical study?

Study enrollment for the Phase II trial is open to 61 patients who meet eligibility criteria, including but not limited to the following, age 16-65, with complete spinal cord injury. Complete injury is defined as ASIA Grade A- neither feeling nor movement below the point of injury. Neurological level of injury: C-5 to T-11. The principal investigators in the study sites are exclusively responsible for determining a patient's eligibility for the trial on the basis of a study protocol that was approved by the appropriate authorities.

NOTE: This is a randomized-controlled clinical trial. This means that 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. ProCord must be administered within 14 days of injury to meet study criteria.

Who to call about enrollment?

Patient, Immediate Family of Patient and/or Physician inquiries:
24 hours a day Patient Recruitment Center:
Please use the ONLINE REFERRAL FORM or one of the following:
Email: 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 of the U.S., please use standard international dialing codes

What does the Patient Recruitment Call Center do?

The Patient Recruitment Call Center collects limited preliminary data that assists the investigators in the determination of eligibility to participate in the study. Following this initial process, when relevant, the patient will then be referred to a study site for screening procedures relevant to study criteria.

Will everyone enrolled receive the ProCord procedure?

Patients will be randomly assigned to treatment and control groups (at the treatment site), two treatment patients for one control patient. The random assignment is not reversible. Patients have a one in three chance of assignment to the control group, which will receive standard care, but not the ProCord procedure.

NOTE: There is NO placebo procedure; there is NO mock surgery. All patients, including those in the control group, will receive standard spinal cord injury rehabilitation and will receive follow-up testing for one year.

Is there a specific window of opportunity?

Yes. ProCord must be administered within 14 days of the injury to meet study criteria. Investigators need to be notified of a potential candidate within a few days of their spinal cord injury in order to give ample time for patients to enroll and participate in the 14-day window of the clinical trial.

What does follow-up include?

All patients (including those in the control group) will receive standard spinal cord injury rehabilitation and will be followed for one year. The 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.

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 (CNS). 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 experimental procedure for patients with acute spinal cord injury.

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.

What is the procedure for ProCord itself?

The idea is to draw blood from the patient, collect a type of white blood cell called a macrophage, "treat and educate" them and then, in a surgical procedure, inject them into the spinal cord for the purpose of stimulating a repair process. Specifically, blood and skin taken from the arm of the patient is processed in a Proneuron Cell Center for approximately one and a half days. The resulting activated macrophages are implanted during a surgical procedure.

Who discovered ProCord?

Proneuron Biotechnologies (www.proneuron.com) is developing ProCord therapy based on the research of Professor Michal Schwartz of the Weizmann Institute of Science in Rehovot, Israel.

Has ProCord been clinically tested in humans before?

There were three previous studies conducted at two different medical centers that enrolled 16 patients coming from the US, Mexico, Israel, Holland, Belgium, and Poland.

What were the results of the Phase I trial of ProCord?

Final results of the Phase I study have yet to be published, as there remain several patients still within the one-year follow up. However, as of September 2004, four of 16 patients from the early studies (all initially diagnosed as suffering from a complete spinal cord injury) became incomplete following the administration of ProCord, obtaining movement and/or feeling not only below their injury but also into their lower extremities.

How is the Phase II study going thus far?

In accordance with FDA guidelines and to insure the integrity of the trial, we are unable to disclose any information pertaining to the status of the Phase II study at this time.

What hospitals are participating in the study of this experimental treatment?

In December 2003, Craig Hospital in Denver, Colorado became the first hospital in the U.S. to participate in the trial. In 2004, three other sites in the U.S. began enrolling as treatment sites. These include: The Mount Sinai Medical Center in New York, New York; Kessler Institute for Rehabilitation in West Orange, New Jersey in cooperation with The University Hospital in Newark, New Jersey; and Shriners Hospitals for Children in Philadelphia, Pennsylvania. Shepherd Center in Atlanta, Georgia, anticipated to become a treatment site in early 2005, is already taking an active role in the study as a referral and rehabilitation center. Additional protocol follow-up sites include: Rehabilitation Institute of Michigan (RIM) in cooperation with Detroit Receiving Hospital in Michigan and Santa Clara Valley Medical Center in California. The Chaim Sheba Medical Center in Israel was the first site to enroll patients in the international, Phase II ProCord study beginning in September 2003.

Who oversees the safety of the clinical trial?

The FDA has approved the conduct of the international, multi-center, randomized-controlled, Phase II study of ProCord and shall review all information collected. An independent safety committee is in place for reviews throughout.

Is there anyone I can speak with who is enrolled in the Phase II Clinical Trial?

No, sorry. The identity of those enrolled in the study is strictly confidential.

How much does it cost to participate?

For patients accepted to the study, there is no cost associated with the actual ProCord procedure. The patient's insurance typically covers the standard spinal cord injury rehabilitation program following enrollment in the study.

Who is Proneuron?

Proneuron Biotechnologies Inc., a Delaware company, is a privately held biopharmaceutical company developing products for the medical treatment of spinal cord injuries and other disorders of the central nervous system. Proneuron's 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. These include: an independently managed, international, multi-center, randomized-controlled Phase II trial of ProCord, autologous incubated macrophages, an experimental procedure for spinal cord injuries and a Phase II program of Cop-1 for the treatment of Huntington's disease (HD), glaucoma and other neurodegenerative diseases. The latter is being managed by Teva as part of the Proneuron's strategic collaboration for development and commercialization of Cop-1 for various neurodegenerative indications. The Company is also developing PN277 for the treatment of additional neurodegenerative diseases.

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