Phase II Clinical Trial for Treatment of Spinal Cord Injuries Expands to U.S.
A clinical trial the hopes to boost the healing function of the immune system and therefore improve recovery for people with acute complete spinal cord injury (SCI within 14 days of injury) has begun enrolling patients at Craig Hospital near Denver.

Proneuron Biotechnologies, a biotech company based in Los Angeles, began its Phase II autologous (from one's own body) activated macrophage trial (called ProCord) in Israel in September. Three more U.S. sites will join in the experimental procedure, including: the Mount Sinai Medical Center in NYC; Kessler Institute for Rehabilitation in West Orange, NJ and Shepherd Center in Atlanta, GA.

Craig has been involved with Proneuron's experimental therapy since 2000; the hospital evaluated two patients who participated in a small Phase I trial in Israel. Results of that trial, released this fall, indicated that of eight patients with neurologically complete injuries, three experienced more functional recovery than would be expected if they had not gotten the treatment.

"The Phase I trial suggests a positive treatment effect, giving clinicians hope that this may prove to be a helpful treatment in improving the outcomes of patients with spinal cord injury," said Daniel P. Lammertse, M.D., Medical Director of Craig Hospital, in a press release.

The Phase one trial in humans was based on promising animal studies. Says Dr. Eti Yoles, Proneuron's VP Product Research & Development, "ProCord appears to markedly improve the degree of neurological recovery. In rats it was shown that several months following treatment, the integrity of the spinal cord was better, with much less cyst formation than in the control group of untreated rats. Cyst formation is a known complication of spinal cord injury that is associated with increased neurological loss and pain."

How Does it Work?
Following any type of tissue injury, a white blood cell called a macrophage, part of the immune system, immediately begins to remove debris from damaged cells. Macrophages also secrete growth factors that initiate the healing process by way of a controlled inflammatory reaction. While this process occurs effectively in most tissues in the body, including peripheral nerves, it does not occur very well in the CNS.

Michal Schwartz of the Weizmann Institute of Science in Israel showed in early experiments that specially treated macrophage cells promoted recovery from spinal cord injury.
Proneuron's ProCord, based on these findings, begins with macrophages isolated from a patient's own blood, activates or "educates" them through a proprietary process that incubates them with cells from the patient's skin. The modified cells are then injected directly into the patient's injured spinal cord.

Normally, the central nervous system (CNS - the brain and spinal cord) is uniquely protected from toxins, invading bacteria or viruses, inflammatory cells and other large molecules through a mechanism called the "blood-brain barrier." Because of this physical isolation, the immune system operates differently in the CNS than in the rest of the body; humans and other mammals have what is called "immune privilege."

This privilege is intended to protect the intricate circuits of the CNS against inadvertent damage by immune cells. But because macrophage cells in the CNS are scarce and inactive relative to their counterparts in the rest of the body, spinal cord trauma overwhelms its usual protection.

The purpose of the clinical trial is to see whether newly activated macrophage cells gain new attributes that boost the immune response in the spinal cord.

The trial has been set up to provide activated macrophage cells in some patients and for the sake of comparison to give others a sham or neutral treatment. Neither the treating physician nor the patient will know whether a patient gets the therapy or not. A total of 61 patients will be recruited to the trial.

Who is Eligible?
A patient will be eligible for inclusion in this trial only if all of the following apply:
-Complete spinal cord injury (ASIA Grade A) between neurological levels from C-5 to T-11
-within 14 days of onset
-age between 16 and 65

A patient will not be eligible for inclusion if any of the following apply:
-More that 14 days since the injury
-women who are pregnant or lactating
-coma
-fever
-gunshot or other penetrating trauma
-or other serious pre-existing medical conditions, including HIV and hepatitis B or C, or other condition or treatment that interferes with the performance or interpretation of the neurological examinations.
(This information supplied by Proneuron)
_____________________

ProCord Clinical Trial Contact Information

If you are interested in finding out eligibility for the ProNeuron clinical trial, please contact their call center. Their contact information is as follows:

ProCord -- Patient Recruitment Center
Tel. 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.
Email:clinical.trial@proneuron.com

The call center will conduct a brief initial screen (was the injury within 14 days, is the patient between 16 and 65 and was the injury non-penetrating).

If the patient is still eligible, an email is sent to ProNeuron and the Study Coordinator for the site where the patient will be treated (for now Craig Hospital or Israel) that contains name, age, date of injury, location and contact info.

The call center also sends a release of medical information form. The Study Coordinator then contacts the family and MD for a more in-depth medical screen. If the patient still appears eligible, they are flown to one of ProNeuron's clinical sites, screened on-site, then enrolled if eligible.

(KLD)