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| About the ProCord clinical trial |
The concept behind Proneuron Biotechnologies' ProCord is to draw blood from the patient to collect macrophages, "treat and educate" them, and then in a surgical procedure inject them into the spinal cord to stimulate the repair process. Specifically, blood and skin taken from the arm of the patient are processed for 1BD days before the resulting activated macrophages are implanted in the surgical procedure.
Procord is an autologous incubated macrophage procedure in Phase 2 trials at several sites in North America and one site in Israel. For a complete list of sites, visit www.spinal cordtrial.com. The randomized-controlled study is being performed under the U.S. Food and Drug Administration's regulations to test the safety and efficacy of the procedure in patients with acute complete spinal cord injuries.
ProCord must be administered within 14 days of the injury to meet study criteria.
For more information about the study, visit www.proneuron.com/ clinicalstudies/index.html. For enrollment, e-mail clinical.trial@ proneuron.com or call (866) 539-0767 or (506) 652-3486.
Source: Proneuron Biotechnologies
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Patients often come into the emergency department with more than a spinal cord injury. They might have chest trauma, head injury, or other orthopedic or soft tissue injuries.
Nurses should realize that because the spinal cord injury robs the patient of sensation in much of the body, the patient might not feel the symptoms of other injuries.
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Bautista says she wishes that more nurses knew about the spinal cord injury guidelines created in March 2002. The American Association of Neurological Surgeons and the Congress of Neurological Surgeons created these 22 guidelines on the management of the acute spinal injury and spinal cord injury.
“In nursing, we should be sure that we’re following these guidelines,” she says.
A new treatment option, which has not yet taken hold in the mainstream, according to Bautista, is GM-1, or Sygen. GM-1 has to be given within 72 hours of injury; so clinicians would probably think more about its administration after patients are stabilized, rather than in the first 24 hours of care. Anecdotal reports are promising for improvement in motor function but study outcomes have not been statistically significant.
Well-known patients, including the late Christopher Reeve, have had GM-1 administered.
Craig Hospital is among the U.S. sites for a Phase 2 trial on ProCord (see sidebar), an autologous incubated macrophage procedure that might improve neurologic recovery.
Lammertse is excited to be able to offer SCI patients participation in a research trial of this type, but he says it’s only an experimental therapy.
One medication in trials in Canada, minocycline, is being studied for its ability to improve neurologic outcome. Another drug, Cethrin, soon should be starting trials in Canada and North America. Given early, this drug also holds hope for improving neurologic outcome in early stages, Lammertse says.
“There is also a trial going on looking at whether early surgical decompression of the spinal cord might improve neurologic outcome,” he says. “This is something that most of us take for granted but it has never been scientifically proven.”
Spinal cord injuries not only devastate the body but also the mind, says Norma McNair, RN, MSN, CCRN, CNRN, clinical nurse specialist in the department of nursing with a focus on neuroscience at UCLA Medical Center.
SCI patients usually don’t fully realize what has happened to them in the first 48 hours of care, she says. But the “fallout” in the acute phase usually occurs when the family starts arriving in a panicked state.
“I think often in the first 48 hours, it’s very difficult to really know the prognosis. So, I think at that point, it’s unrealistic for nurses to say the patient is never going to walk again. It’s important that nurses answer patients questions honestly, provide what information they can, but not take away their hope,” McNair says. “Most patients with spinal cord injuries think they’re going to get better, and I think that’s what sustains them.”
Lisette Hilton is freelance writer for NurseWeek. To comment on this story, send e-mail to editorca@nurseweek.com.
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