Stem Cells Inc. Reports Additional Spinal Cord Injury Patients Transplanted with Neural Stem Cell Line Show Functional Improvements

StemCells, Inc. has developed a proprietary stem cell line called HuCNS-SC.  This stem cell line is a neural stem cell line, and neural stem cells can readily form neurons (the conducting cells of the nervous system), or glial cells (the support cells of the nervous system). In order to determine if these cells can regenerate spinal nerves in patients who have suffered a spinal cord injury, StemCells Inc. has commissioned a clinical trial to test their cells in human spinal cord injured patients.

Early indications showed that the HuCNS-SC cells were safe, but some patients have shows improvements in sensation.  Now StemCells Inc has issued an announcement that these initially reported improvements in only a few patients have also been confirmed in other patients.

According to Armin Curt, M.D., Professor and Chairman of the Spinal Cord Injury Center at Balgrist University Hospital, University of Zurich, and the principal investigator of their Phase I/II trial, the initial improvements that were observed in the first two patients treated with their HuCNS-SC neural stem cells have now been observed in two additional patients who have also been treated with these stem cells. These results come from an interim analysis of recent clinical data.

In a presentation to the Annual Meeting of the American Spinal Injury Association in San Antonio, Texas, Dr. Curt showed data on AIS B subjects who were transplanted with HuCNS-SC neural stem cells in the Phase I/II chronic spinal cord injury trial. This trial is different from the AIS A patients who have no mobility or sensory perception below the point of injury, since AIS B subjects are less severely injured, and are paralyzed but retain sensory perception below the point of injury. Two of the three AIS B patients who are participating in the study showed significant gains in sensory perception. The third patient remained stable.  These interim results confirm the favorable safety profile of these stem cells and the surgical implant procedure used to transplant them into the spinal cords of spinal cord injury patients.

Also included in Dr. Curt’s presentation was data from a total of five new subjects with a minimum six-month follow-up. In total, Stem Cells Inc. has now reported clinical updates on a total of eight of the twelve patients enrolled in its Phase I/II clinical trial that is testing this Company’s proprietary HuCNS-SC (purified human neural stem cells) platform technology for treating chronic thoracic spinal cord injury.

“Thoracic spinal cord injury was chosen as the indication in this first trial primarily to demonstrate safety. This patient population represents a form of spinal cord injury that has historically defied responses to experimental therapies and is associated with a very high hurdle to demonstrate any measurable clinical change. 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 responses to transplant may be more readily anticipated.”

“We are seeing multi-segmental gains and a 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. This is even more significant because of the time that has elapsed from the date of injury, which ranges from 4 months to 24 months across the subjects with sensory gains,” said Stephen Huhn, M.D., FACS, FAAP, vice president, CNS clinical research at StemCells, Inc. “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.”

Spinal Cord Inury Trial Using StemCells, Inc. Stem Cell Line Shows Positive Results

StemCells, Incorporated is conducting a Phase I/II clinical trial in which the company’s proprietary stem cell line, their HuCNS-SC stem cell lines, which is a purified human adult neural stem cell line, is implanted into the spinal cords of patients who have suffered a spinal cord injury. This clinical trial is designed to determine the safety and preliminary efficacy of HuCNS-SC as a treatment for spinal cord injury.

The goal for this clinical trial is to treat 12 patients who have suffered thoracic (chest-level) neurological injuries at the T2-T11 level. In order to be candidates for this procedure, the patients must have suffered their spinal cord injuries recent enough so that they can have the stem cells transplanted into their spinal cords within three to twelve months after their injury. The clinical trial will assess the safety of the procedure and its efficacy. Efficacy will be specifically assessed by determining the recovery of such features as sensation, motor function and bowel/bladder function. The first three patients have already been treated and these patients have spinal cord injuries that are classified as “ASIA category A.” This is a shorthand for American Spinal Injury Association category A. Category A means that there is no sensory or motor function below the level of the injury. The next group of patients to be treated will have less severe injuries (ASIA-B – sensory but no motor function below the level of the injury) and the third group will be even less severe injuries (ASIA-C – motor function is preserved, but most of the major muscle have reduced function).

The trial is being conducted at Balgrist University Hospital, University of Zurich, which is a world leading medical center for spinal cord injury and rehabilitation, and is open for enrollment to patients in Europe, Canada and the United States. Enrollment for those patients in the second cohort with ASIA-B category spinal cord injuries is now underway.

As previously reported, StemCells, Inc. reported at a conference on the results of their clinical trial. They reported that in six months after the first patients were treated, the patients showed no severe side effects. Even more favorably, the patients showed considerable gains in sensory function in two of the three patients compared to pre-transplant baselines. The third patient remains stable.

Armin Curt, M.D., the principal investigator for this clinical trial, presented these data at the 51st Annual Scientific Meeting of the International Spinal Cord Society in London, England. This clinical trial represents the first time that neural stem cells have been transplanted as a potential therapeutic agent for spinal cord injury. The recovery of sensory function in the two patients is certainly a remarkable finding, and gives new hope to those with a spinal cord injury.