Please note, that the Proneuron clinical trial entitled "FDA Phase II Autologous Incubated Macrophage Clinical Trial for Patients with Acute SCI" described below, has been temporarily closed to new enrollees. Please check back periodically for new updates.

Proneuron Clinical Research Trial:

Proneuron Biotechnologies, Inc. has expanded its “FDA Phase II Autologous Incubated Macrophage Clinical Trial for Patients with Acute Spinal Cord Injury” from Israel to the United States. Rehabilitation Institute of Michigan, has been selected as one of five designated clinical research trial sites in the United States.

• What is the Phase II study?
• What are macrophages?
• What is an autologous incubated macrophage?
• What is the procedure for ProCord itself?
• What is the scientific concept behind ProCord?
• Who can participate in the clinical study?
• What were the results of the Phase I trial of ProCord?
• Where can I learn more about the study on the web?
• Who to call about enrollment?

• What is the Phase II study?
  The Phase II clinical trial is an international, multi-center, randomized-controlled study performed under Food and Drug agency’s 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”.
   
  
• 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 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 1 1/2 days. The resulting activated macrophages are implanted during a surgical procedure.
   
  
• What is the scientific concept behind ProCord?
  When most parts of the body are injured, the immune system activates to stimulate a repair process – for example, if you scrape your hand, it would heal in a few days or so. Such is the way the peripheral nervous system works. This is not the case in the central nervous system (CNS) - which includes the spinal cord, the optic nerves and the brain.
   
  
• 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 ages 16-65, with complete spinal cord injury. ProCord must be administered within 14 days of injury to meet study criteria. 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 to determine a patient eligibility to 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.
   
  
• 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, according to an abstract presented by Dr. Nachshon Knoller, Principal Investigator at Chaim Sheba Medical Center, at the Annual Conference of the Israel Neurological Society, January 29-30, 2004, entitled An open label study of autologous incubated macrophagesin patients with acute complete spinal injury, “ Of the first eight patients who have completed the study, three converted from ASIA A to C. Of the patients who remained ASIA A, three showed varying degrees of increase in sensory scores, as well as improved signs of somatosensory evoked potentials, objective evidence of restored nerve conduction. Of the later patients still in follow-up, one has recently converted to ASIA B. There were no adverse events attributed to the implantation of autologous macrophages.
   
  
• Where can I learn more about the study on the web?
  Please visit Proneuron at http://www.proneuron.com/clinicalstudies/index.html
   
  
• Who to call about enrollment?
  Patient, Immediate Family of Patient and/or Physician inquiries: 24 hour a day Patient Recruitment Center:
   
  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 code

                                                      For more information, please call  
                                                                   1-866-SCI-CENTER