New hope for reversing the effects of spinal cord injury

"Our phase one/two clinical trial had one goal: to give patients who have no other treatment options some hope," said Hatem E. Sabaawy, MD, PhD, an assistant professor of medicine in the molecular and regenerative medicine program at Robert Wood Johnson Medical School. "Early findings have concluded that we have met our goal and can improve the quality of life for individuals with spinal cord injuries by providing a safe treatment that restores some neurological function."

Dr. Sabaawy led a clinical trial that included 70 patients who had cervical or thoracic spinal cord injuries and were previously treated for at least six months without response. The patients were randomized into two groups, both of which were given physical therapy treatment. One of the groups also received stem cells derived from their own bone marrow injected near the injury site. Using the American Spinal Injury Association Impairment (AIS) Scale, patients received neurological and physical evaluations monthly for 18 months to determine if sensory and motor functions improved.

"Of primary importance, there was a notable absence of side effects in patients treated with stem cells during the course of our investigation," added Dr. Sabaawy, who also is a resident member of The Cancer Institute of New Jersey at Robert Wood Johnson Medical School.

None of the patients in the control group who received only physical therapy showed any improvement in sensory or motor function during the same time frame. Although the scale of injuries differed, all patients who were treated with a combination of bone-marrow derived stem cells and physical therapy responded to tactile and sensory stimuli as early as 4 weeks into the study. After 12 weeks, they experienced improvements in sensation and muscle strength, which was associated with enhanced potency and improved bladder and bowel control that eventually allowed patients to live catheter-free. Patients who showed improvement based on the AIS scale also were able to sit up and turn in their beds.

"Since the emergence of stem cells as a potential therapy for spinal cord injury, scientists have diligently sought the best application for using their regenerating properties to improve a patient's mobility," said Joseph R. Bertino, MD, University Professor of medicine and pharmacology, interim director, Stem Cell Institute of New Jersey and chief scientific officer at The Cancer Institute of New Jersey. "Dr. Sabaawy's discovery that treatment is more successful when stem cell therapy is combined with physical therapy could provide a remarkable, and hopefully sustainable, improvement in the overall quality of life for patients with spinal cord injury."

At the end of 18 months, 23 of the 50 patients who received both physical therapy and stem cell therapy showed a significant improvement of at least 10 points on the AIS scale. Several were able to walk with assistance. In addition, more gains were made in motor skill control by patients with thoracic spinal cord injuries, suggesting that patients with thoracic spinal cord injuries may respond better to the combined treatment.

Dr. Sabaawy however cautioned that more studies are needed with a larger number of patients to test different cell dose levels and intervals at which stem cell therapy should be delivered.

"Although a cure for spinal cord injury does not yet exist, it is clear that the regenerative and secretory properties of bone-marrow derived stem cells can improve symptoms of paralysis in some patients when coupled with the current standard of care that physical therapy provides," said Dr. Sabaawy. "We will continue monitoring our patients for long-term safety effects of stem cell therapy and work to expand our research through a phase two clinical trial that can be conducted at multiple centers nationwide and internationally."