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February 24th, 2005, NEW JERSEY JEWISH NEWS

New Jersey healthcare facilities test promising Israeli spinal cord treatment

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Two New Jersey medical facilities are looking for volunteers to test an experimental drug developed in Israel that could someday provide a cure for many spinal cord injuries.

The drug is ProCord, a blood-based serum that holds the promise of healing and regenerating damaged cells in an affected spinal cord, if an injury victim is treated within two weeks after being paralyzed.

Its safety and effectiveness are now under close scrutiny at University Hospital in Newark and the Kessler Institute for Rehabilitation in West Orange, along with medical centers in New York, Denver, Philadelphia, and Israel.

The drug was developed by a company called Proneuron Biotechnologies at the Weizmann Institute of Science in Rehovot, Israel. Derived from specially treated white cells isolated from patients’ own bloodstreams, it is injected directly into damaged spinal cords within two weeks after a person is injured. In its earliest trials, ProCord was effective for 30 percent of its recipients.

“They experienced neurological regeneration not explained by chance,” according to Kenny Hosack, director of public relations at Craig Hospital in Denver, a site for the drug’s phase-one trials. “Although some 70 percent were not helped, no one’s condition was made worse,” he said. “No safety issues arose.”

“Our best hope at this point is to turn patients with complete spinal cord injuries to ones who regain function of some parts of their bodies that were paralyzed by traumatic injury,” said Dr. Karen Kepler, director of the spinal cord injury program at University Hospital.

“We need volunteers, and we need them within 14 days [of their injury].”

The treatment is a surgical procedure that uses white cells and tissue from parts of a patient’s body where — unlike the spinal cord — injuries can heal rapidly. “It is invasive. We have to cut through bone to administer the injection in the general area of the lesions,” Kepler told NJJN. “Prior to this, we would inject people with steroids to minimize swelling around their injury sites. Now we have something that holds more promise.”

As the first part of the experiment, the patients at University Hospital are divided into two groups. One is administered the ProCord injection, the other is not. But both are transferred to Kessler Institute for Rehabilitation after completing treatment at University Hospital, and both are given follow-up exams every three months for the next year.

“We understand the disappointment some volunteers may feel if they are not selected to receive ProCord, but we do provide them with treatment and rehab, and they are a very important part of our experiment,” Kepler said.

Steven Koltenuk, a registered nurse who is the liaison between the programs at University and Kessler, said, “The results from the phase-one trials [in Belgium and Israel] were really amazing.” Three of 10 patients regained bodily functions below the waist.

Dr. Steven Kirshblum, director of Kessler’s spinal cord injury services, told NJJN, “We were interested enough in these results to want to get involved in this experiment, and the indications are that early intervention may have a dramatic impact on some of the most severely injured patients.”

Beyond the 14-day window of opportunity, Koltenuk said that criteria for admission to the program are “very strict. Patients must be between 18 and 65 years old. Their spinal cords cannot have been severed from their injuries. They cannot have penetrating wounds, from a stabbing or a gunshot. They cannot be breathing on ventilators. So far, of the seven people we’ve evaluated, only one has qualified.”

“This is one of the most promising studies we have seen,” said Koltenuk. “Since it uses a patient’s own cells, it does not involve the ethical issues surrounding stem cells,” such as the use of embryonic tissue or potential human cloning.

According to Kirshblum, the phase-two experiment involving 61 patients at the five hospitals should be completed “within a year to a year and a half, and if the results are positive, we can move on to a much broader phase three.” Testing a broader patient population would be the final step before the ProCord procedure gets submitted for approval by the Food and Drug Administration.

Potential volunteers or their family members can apply for admission to the program at clinical.trial@proneuron.com or by calling 866-539-0767.

Those accepted will be required to use their own health insurance to pay for their hospitalization and rehabilitation. According to Kepler, Proneuron will subsidize the cost of the experimental injections and the medical expenses of volunteers who are uninsured.

Robert Wiener can be reached at rwiener@njjewishnews.com.

Copyright 2005 New Jersey Jewish News. All rights reserved. For subscription information call 973.887.8500.


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Proneuron Biotechnologies is engaged in research
related to spinal cord injuries and paralysis cure.

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