Groundbreaking procedure at Craig Hospital offers hope to those
with spinal injuries
By Bill ScanlonENGLEWOOD - A
skid into a tree, a bad fall on an icy mogul, a fall from a roof - it takes
just a second to turn a healthy person into a quadriplegic or paraplegic.
For thousands of years, a severe spinal cord injury meant
certain death. For much of the last century, it meant a painful year or two
before the grip of death.
For the past 40 years, it has meant life in a wheelchair,
with pressure sores, no control of vital organs and no feeling below the
point of injury.
But now there is a glimmer of hope that at least partial
feeling can be returned to those with spinal cord injuries and that some can
rebound enough to have some control over their limbs.
Newly paralyzed people from across the country are making
the pilgrimage to Craig Hospital, hoping an exotic new procedure can restore
feeling to their toes, feet, arms and legs.
Craig is the only hospital in the United States certified
to conduct the trial operation, which uses the body's own cells to stop
nerve deterioration soon after a spinal cord injury.
Although it's unlikely the procedure will enable any of
the trial patients to walk on their own again, most are expected to get some
feeling back in their limbs. They also may regain some bladder control or
enough body movement to relieve pressure wounds caused by wheelchairs and
beds.
"Help is on the way - it really is," said Christopher
Reeve, the long-paralyzed actor and activist for those with spinal cord
injuries. Reeve was referring to the research by Proneuron Biotechnologies
Inc., of Tel Aviv, Israel.
Proneuron pioneered the process, performing the first
trials in Israel in 2000. It chose Craig, considered one of the top five
rehabilitation hospitals in the U.S., to be its first American partner.
Wound-healing cells
In simplest terms, "We educate the cells to start the
wound-healing process," said Nir Nimrodi, a Proneuron researcher stationed
at Craig.
The body has special wound-healing white blood cells
called macrophages, which are abundant in the skin, liver, kidneys and
blood, he said. They eat bacteria and fix our injuries.
Unfortunately, macrophages are in short supply in the the
spinal cord and the brain. They also work less efficiently in those areas.
But Dr. Michal Schwartz of the Weizmann Institute in
Rehovot, Israel, theorized that spinal cord injury victims might be helped
by injecting macrophages from elsewhere in the body into the spinal cord at
the site of the injury.
Proneuron Biotechnologies worked with Schwartz to come up
with a way to isolate macrophages and combine them with skin cells in a way
that multiplies their number and power, said Nimrodi.
The first trial began in Israel in 2000. Eight patients
were injected with the supercharged macrophage cells and three of them
regained significant feeling, 10 times greater than by chance alone.
Normally, people with complete spinal cord injuries -
where the cord is severed or so damaged that there is no feeling or ability
to move below the injury - have only a 3 percent chance of regaining any
significant feeling in the toes or limbs.
One of those first eight patients, and the first to
undergo the treatment, was a Colorado woman, Melissa Holley, of Ridgway, who
was badly injured in a car accident on June 25, 2000.
Holley, now a 22-year-old college student, cannot walk
unaided, but she can shuffle her legs to help get herself from her
wheelchair to the bed and elsewhere. She said recently she has "feeling
pretty much everywhere."
Nimrodi calls Holley "a great success story, but not our
best."
A patient who fell from a roof and was a quadriplegic now
can walk in water with help from therapists, he said.
Those successes were enough to convince the U.S. Food and
Drug Administration to approve a larger human trial in this country.
Two-week window
The trials have just begun at Craig, where officials
won't say how many patients have undergone the procedure. To protect the
study's scientific validity, it's best if even doctors don't know details of
the study, including which patients have received the injections and which
have been given placebos.
But they will talk about how the program works:
To be effective, the macrophage cells must be injected
within 14 days of the accident.
Immediately after an injury, if the responding doctor
knows of the Craig-Proneuron study, he or she makes contact and an initial
screening is done. The patient must have a complete spinal cord injury, be
between 14 and 65, and cannot have had a blood transfusion within the
previous 36 hours.
If the patient passes that hurdle, then he or she goes to
Craig for additional screening. If doctors think the patient is a good
candidate for the trial, they harvest some blood and skin. The blood and
skin are moved to a clean room, where isolating the macrophage cells takes
36 hours.
When all is ready, the patient and the cells are taken to
an operating room at the adjacent Swedish Medical Center. Craig neurosurgeon
Dr. Scott Falci injects the macrophage cells at numerous sites along the
injured spine.
Building momentum
Craig, known for its expertise in spinal cord injuries,
has sent notices about the trial to trauma doctors and neurosurgeons across
the country, said Craig Hospital President Dennis O'Malley.
But he knows that most referrals originate with family
members who got on the Internet as soon as their loved one had the accident.
"They're likely to come across this trial in the first 10
minutes of their search," O'Malley said. "Once we get a little momentum and
the word starts to spread, we hope to enlighten the trauma community" about
macrophages' potential, O'Malley added.
Craig is one of 13 regional model facilities for spinal
cord injury, as designated by the federal government, and has treated more
people with spinal cord injuries than any other facility in the nation.
Craig Hospital also is working with the Karolinska
Institute in Sweden on stem cell research, hoping those cells can actually
reconnect damaged spinal cords in people with older injuries.
The Proneuron study doesn't use stem cells, so it isn't
caught in the controversy over whether cells from aborted fetuses should be
used for medical research.
Nimrodi said it would be irresponsible to make promises
to the Phase II patients that they'll be able to walk again. On the other
hand, he won't rule out greater strides down the road.
"I'm an optimistic person," Nimrodi said. "I'm not
willing to accept that someday people getting these injections won't be able
to walk a mile."