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Media Coverage: 2005-6 | 2003-4 | 2001-2 | 1998-2000
Monday, March 07, 2005
THE STAR LEDGER
REGENERATING HOPE FOR A PARALYSIS CURE
By
Very soon, perhaps in a few days or weeks, someone in the United States will injure his or her spinal cord and become paralyzed. They may crash their car, slip on ice or fall at a job site.
One of these newly injured people may be transported to Newark for an experimental treatment that is invigorating the search for a paralysis cure.
University Hospital is one of three sites nationally that is testing specially treated immune cells -- called macrophages -- that are injected into the spinal cord. The treatment may not help patients walk, but they may be able to regain sensations or recover some movement.
Proponents want to open new avenues of research, and counter thinking that the spinal cord can never be repaired.
"This is the first real, approved effort in humans," said Robert F. Heary, the neurosurgeon who will perform the intricate procedure. He is an associate professor at the UMDNJ-New Jersey Medical School. "Other treatments have only been done on animals."
Anything that regenerates the spinal cord would be heralded since little now can help the more than 11,000 Americans who suffer the injuries each year.
Criteria for the study are strict: Patients must have been injured within 10 or 11 days; have a complete spinal cord injury, which means no feeling below the site of the injury, and be otherwise healthy.
As Heary waits for a patient, he spreads the word to trauma centers nationwide. Patients who meet the criteria will be transferred to University Hospital or Mount Sinai Medical Center in New York, or a third site in Denver.
The study is the second round of patient experiments with macrophages. Macrophages have been likened to little fire engines, rushing to the scene of injury, cleaning up debris, and then secreting chemicals that aid in healing and regeneration. Macrophages work well through most of the body, but not in the spinal cord.
The macrophage treatment, developed by Proneuron Biologies Inc., an Israeli company, takes macrophages removed from skin and blood in the patient's own upper arm. The cells are then treated to help them work in the spinal cord. Then, they are injected back into the patient through a micro-neurosurgical operation. The operation enables the macrophages to circumvent barriers that keep them out of the central nervous system. In Phase I trials in Israel and Belgium, which began in 2001, the treatment was given to 14 newly injured people. Thirty percent showed significant improvement.
In Newark, once a patient is brought to the spine center, Heary will remove cells. The cells will be activated at Progenitor Cell Therapy in Hackensack with technology based on research by Michal Schwartz of Israel's Weizmann Institute of Science.
"Things have to move quickly," said Karen Kepler, director of the Spinal Cord Injury Program at the medical school and a co-investigator of the study, which is also being coordinated by the Kessler Institute of Rehabilitation in West Orange.
Researchers must learn of a person's injury as soon as possible, hopefully by day five. Patients must get to Newark by day 10 or 11. It takes 36 hours from the time the cells are removed until they are transplanted in the two-hour procedure, which must be completed 14 days after the injury. The study will end after researchers at all sites have enrolled 61 people.
One third of the patients will not get the treatment, however.
"This is science," Kepler said. "We have to have a control group to determine if changes are really due to the treatment and not to any natural recovery process." Kepler acknowledged that telling a person who made it into the trial that they will not get the experiment will be wrenching.
A SUCCESS STORY
Justin D. Richardson, a 24-year-old college student in North Carolina, is among the few to undergo the macrophage procedure. He was 22, a competitive swimmer who trained lifeguards, when he was out with friends at a pool on Aug. 10, 2003. He dived in without looking.
"I nailed my head on the stairs," he said in an interview from his apartment in Raleigh. "I should have known better."
He was paralyzed from the chest down. A family friend had seen news of a macrophage study in Israel.
Richardson was only the 15th person to get the transplant and he had no idea if it would work. After the accident, he had limited use of his hands, which curled into claws. He could feel nothing from his mid-chest down. A month after the injections, while still in the hospital, he could feel clothes being slipped off his legs. Soon, doctors asked him to close his eyes and he was able to tell them where they were touching him.
"In the past year-and-a-half, every single muscle and nerve in my hand has come back. That's the main thing I am thankful for," he said. He now has some bladder sensation, and normal touch sensation from his stomach up. He can use a wheelchair and live on his own, and has returned to college.
"This treatment has allowed me to go back to the life I had, as much as I can in a wheelchair," he said. "Doctors said they would not be surprised if I continued to improve."
REEVE'S DEATH WAS SETBACK
The 250,000 Americans with spinal cord injuries need good news. The past six months have been difficult.
The October death of Christopher Reeve, the actor paralyzed after falling from a horse nine years ago, was a blow. Another hit came with comments by U.S. Sen. Bill Frist, who criticized vice presidential candidate John Edwards when he said stem cell research could help people like Reeve walk again. Frist, a physician, called the comments "shameful" and said they gave people false hope.
Wise Young, the noted spinal cord researcher at Rutgers University, said comments by Frist hurt people still stung by Reeve's death.
"Here we had the Senate majority leader saying that people should not even hope," Young said. "His message drove in pessimism."
Young, whose own work has shown promise in labs, called macrophages "a very interesting hypothesis." He said other potential treatments are moving forward.
On April 12, people with paralysis plan a rally in Washington, D.C., to push for money to take promising lab treatments -- some have enabled paralyzed rats to walk -- and test them in people. Dana Reeve, Christopher's widow, will speak.
Richardson also plans to talk about his experience.
"These trials are so important," he said. "I will tell people how I benefited from one."
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Proneuron Biotechnologies is engaged in research
related to spinal cord injuries and paralysis cure.
