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|StemCells, Inc. Provides Update on Its Phase I/II Study in Spinal Cord Injury|
The presentation included the first data on AIS B subjects to be transplanted in the Phase I/II chronic spinal cord injury trial with the HuCNS-SC®cells. In contrast to AIS A patients who have no mobility or sensory perception below the point of injury, AIS B subjects are less severely injured, they are paralyzed but retain sensory perception below the point of injury. Two of the three AIS B patients had significant gains in sensory perception and the third remained stable. The interim results also continue to confirm the favorable safety profile of the cells and the surgical implant procedure.
The presentation included data from a total of five new subjects with a minimum six month follow up. In total, the Company has now reported clinical updates on a total of eight of the twelve patients enrolled in its Phase I/II clinical trial using the Company's proprietary HuCNS-SC (purified human neural stem cells) platform technology for 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.
"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
A copy Dr.
The Company's Phase I/II clinical trial is designed to assess the tolerability, safety and preliminary efficacy of HuCNS-SC cells as a treatment for chronic spinal cord injury. The Company enrolled 12 subjects with thoracic (chest-level) neurological injuries at the T2-T11 level, classified as complete (AIS A) or incomplete (AIS B) according to the American Spinal Injury Association Impairment Scale. Seven of the patients enrolled in the study were classified as AIS A and 5 classified as AIS B.
All twelve patients have been enrolled and transplanted with HuCNS-SC cells. Each of the first three subjects suffered a complete injury prior to enrolling in the study. Twelve months after transplantation of the HuCNS-SC cells, data showed multi-segment gains in sensory function in two of the first three subjects, one of which converted from a complete injury classification to an incomplete injury. The third subject in this cohort remained stable, 12 months after transplantation.
The trial enrolled spinal cord injury patients at three centers: the
All subjects who enrolled in the trial received HuCNS-SC cells through direct transplantation into the spinal cord and underwent temporary treatment with immunosuppressive drugs. Evaluations are being regularly performed in the post-transplant period in order to monitor and assess the safety of the HuCNS-SC cells, the surgery and the immunosuppression, as well as to measure any change in neurological function. Preliminary efficacy is being evaluated based on defined clinical endpoints, such as changes in sensation, motor function and bowel/bladder function. The Company intends to follow the effects of this intervention long term, and each of the subjects will be invited to enroll in a separate four-year observational study after completing the Phase I/II study. In addition, the Company plans to initiate a controlled Phase II efficacy trial in in cervical spinal cord injury in 2014.
Information about the Company's Spinal Cord Injury program can be found on the
Additional information about the clinical trial is available at:
and at the
Apart from statements of historical fact, the text of this press release constitutes forward-looking statements within the meaning of the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended, and is subject to the safe harbors created therein. These statements include, but are not limited to, the prospect for evaluating trial patients for changes in their sensation, motor function and bowel/bladder function; the potential of the Company's HuCNS-SC cells to treat spinal cord injury and other central nervous system diseases and disorders; and the future business operations of the Company. These forward-looking statements speak only as of the date of this news release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Such statements reflect management's current views and are based on certain assumptions that may or may not ultimately prove valid. The Company's actual results may vary materially from those contemplated in such forward-looking statements due to risks and uncertainties to which the Company is subject, including the fact that additional trials will be required to demonstrate the safety and efficacy of the Company's HuCNS-SC cells for the treatment of any disease or disorder; uncertainty as to whether applicable regulatory agencies will permit the Company to continue clinical testing in spinal cord injury or in future clinical trials of proposed therapies for other diseases or conditions; uncertainties regarding the Company's ability to obtain the increased capital resources needed to continue its current and planned research and development operations; uncertainty as to whether HuCNS-SC cells and any products that may be generated in the future in the Company's cell-based programs will prove safe and clinically effective and not cause tumors or other adverse side effects; and other factors that are described under the heading "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended