In the blink of an eye, anyone could experience a life-transforming, paralyzing spinal cord injury. It happens to about 11,000 Americans each year.

With no cure for spinal cord injuries, rehabilitation has been the cornerstone of care for these patients. Now, however, a Phase II clinical trial of a new technology offers a revolutionary concept: early treatment of acute spinal cord injury. The study of ProCord technology, which utilizes the patient’s own white blood cells, is being conducted at six centers in the United States, including University Hospital in Newark.

“Spinal cord injury is tragic because so many of the people affected are in the prime of their lives, and conventional treatment offers them little improvement,” says Dr. Robert F. Heary, associate professor of neurological surgery at New Jersey Medical School, a spine surgeon at University Hospital, and one of the study’s principal co-investigators. A preliminary study of ProCord “showed substantially better gains than what would have been expected,” he says.

When the Spinal Cord is Damaged

Dr. Robert Heary

A person’s ability to walk, talk, breathe, and even control the bowel and bladder is due in significant measure to the spinal cord, the body’s largest collection of nerves. Running from the base of the brain to middle of the back, the spinal cord is a highly sophisticated messenger system that facilitates both voluntary and involuntary movement.

The spinal cord is protected by the spinal column, which is comprised of bony vertebrae. However, the bones do not always withstand the force of trauma, which can cause bruising and compression of the spinal cord and damage critical nerves. The impact, ranging from loss of nerve sensation to paralysis, depends on where the injury occurs. The closer to the neck the injury is located, the more severely the body is affected.

The Best Defense

When a person’s spinal cord is injured, physicians administer steroids to reduce swelling in the spinal cord and hopefully, minimize damage to the nerve cells. The body’s white cells, so essential in fighting infections and generating repair to body tissue, are in scarce supply within the central nervous system.

	The activated white blood cells (above) are injected directly into the spinal cord (below)

That, says Dr. Heary, is where researchers believe ProCord comes in. This new technology, developed by Proneuron Biotechnologies, takes white cells (also called macrophages) from the patient’s body, activates them using a proprietary method, and injects the cells back into the patient’s spinal cord. The activated macrophage cells are believed to trigger an immune response that protects nerve cells from deterioration.

The results of the Phase I study of ProCord, conducted in Israel and Belgium, were promising. One-third of the study patients showed significant improvement.

The Phase II trial of ProCord will involve up to 60 patients, and University Hospital and its partner in the study, the Kessler Institute for Rehabilitation in West Orange, anticipate enrolling spinal cord injury patients from around the country. Not all people with spinal cord injuries are eligible, however. The study is open to people between the ages of 16 and 65 who have a “complete” or “ASIA-A” injury (full loss of motor and sensory nerve function below a certain level) and can breathe on their own. Time is also an important factor, as treatment must begin between five and 14 days of the spinal cord injury.

Dr. Karen Kepler, an assistant professor of physical medicine and rehabilitation at New Jersey Medical School and director of the school’s spinal cord injury program, will evaluate patients for possible enrollment in the study. The study patients will be randomly assigned to one of two groups: two-thirds will receive the ProCord treatment, and the other third will serve as the control group. All of the University Hospital study patients will receive comprehensive spinal cord examinations, standard spinal cord rehabilitation at the Kessler Institute, and follow-up testing for one year.

Dr. Karen Kepler

For a patient receiving the ProCord treatment, blood and skin samples are taken from the upper arm and taken to a cell processing center in New Jersey. Upon their return to University Hospital, the specially treated macrophage cells are implanted into the patient’s spinal cord via a surgery performed by Dr. Heary. Six injections of the cells are given below the area of injury. The researchers will assess the treatment’s impact on function and nerve sensation, if any, during the course of one year.

Unlike some other proposed treatments for spinal cord injury, ProCord probably will not evoke controversy. “We are using stem cells, but from the patients themselves, not from a fetus,” says Dr. Heary. “We’re going to take what is a devastating injury and find a way of treating it using cells from the patient’s own body."

For more information about enrollment in the study, referring physicians, patients, and immediate family members may call the UH study coordinator 24 hours a day at (973) 641-0600.