Armin Curt, MD, principal investigator in the StemCells trial for spinal cord injury patients, gave an update on the Phase I/II trial at the American Spinal Injury Association annual meeting in San Antonio.
The trial treats chronic spinal cord injury patients with HuCNS-SC cells administered through direct transplantation into the spinal cord. The patients also underwent temporary treatment with immunosuppressive drugs. Here are five things to know about the clinical trial:
1. The interim analysis shows significant post-transplant gains in sensory function first reported in two patients have now appeared in two additional patients. The presentation included data from five new subjects with a minimum six-month follow-up. "Thoracic spinal cord injury was chosen as the indication in the first trial to demonstrate safety. This patient population represents a form of spinal cord injury that has historically defied response to experimental therapies and is associated with a high hurdle to demonstrate any measurable clinical change," said Dr. Curt in a news release.
2. The first group of spinal cord injury patients participating in the trial had no mobility or sensory perception below the point of injury; patients in the second group were less severely injured — they were paralyzed but retained sensory perception below the point of injury. Two of the three patients in the second group had significant sensory perception gains. "We are seeing multi-segmental gains and return of function in the cord in multiple patients. This indicates something that was not working in the spinal cord now appears to be working following transplantation," said Stephen Huhn, MD, FACS, FAAP, vice president of CNS clinical research at StemCells.
3. The data becomes increasingly significant because the time of injury elapsed significantly to the time of treatment. The patients were treated four months to 24 months after injury and still experienced sensory gains. "These results are exciting with respect to the expansion of this trial into patients with cervical injury because even a gain of one to two segments in cervical spinal cord injury patients can allow for additional function in the upper extremities," said Dr. Huhn.
4. Thus far in the study, the surgeons saw the first changes one to three months after transplantation. They also observed:
• No segmental deterioration
• No loss of overall functional capacity
• No deterioration of bladder sensation in the second group
• No unexpected or unknown pain conditions
• No change or induction of novel pain syndromes
• No exacerbation of pre-existing spasticity
"Because of the severity associated with thoracic injury, gains in multiple sensory modalities and segments are unexpected, and changes in motor function are even more unlikely," said Dr. Curt. "In contrast, the cervical cord, which controls more motor function, may represent a patient population in which motor response to transplant may be more readily anticipated."
5. According to the University of Alabama at Birmingham's National Spinal Cord Injury Statistical Center, there are about 12,000 new cases of spinal cord injury per year. The number of people living in the United States with SCI was estimated at 273,000 in 2013, and almost half of all injuries occurred between the ages of 16 and 30. More than 80.7 percent of SCI reported in national databases occur among males. The average cost for patients living with SCI is $70,575 per year, depending on education, severity of injury and pre-injury employment.
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