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|StemCells, Inc. Initiates Phase II Clinical Trial in Cervical Spinal Cord Injury|
The Pathway Study is the first clinical study designed to evaluate both the safety and efficacy of transplanting stem cells into patients with traumatic injury to the cervical spinal cord. The trial will be conducted as a randomized, controlled, single-blind study and efficacy will be primarily measured by assessing motor function according to the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI). The primary efficacy outcome will focus on change in upper extremity strength as measured in the hands, arms, and shoulders. The trial will follow the patients for one year from the time of enrollment.
Earlier this year, the Company completed enrollment in an open-label Phase I/II clinical trial in thoracic SCI and reported interim results from this trial on eight patients with at least six months of follow-up post transplantation. Half of the patients transplanted had significant post-transplant gains in sensory function. The interim results also continue to confirm the favorable safety profile of the cells and the surgical procedure. Based upon the strength of the interim data from its thoracic SCI study, the Company made the decision to move forward with the first in human clinical trial to assess the efficacy of stem cell transplants for the treatment of cervical SCI.
"The initiation of the Pathway Study represents a major milestone for
The first site initiated into the Pathway Study is the
"Our center has been a leader in clinical research aimed at curing paralysis," said Allan D. Levi, M.D., Ph.D., F.A.C.S., Robert M. Buck Distinguished Chair in Neurological Surgery at the
About the Pathway Spinal Cord Injury Clinical Trial
The Company's Pathway Phase II clinical trial titled "Study of Human Central Nervous System (CNS) Stem Cell Transplantation in Cervical Spinal Cord Injury," will evaluate the safety and efficacy of transplanting the Company's proprietary human neural system stem cells (HuCNS-SC cells) into patients with traumatic injury in the cervical region of the spinal cord. This is a randomized, controlled, single-blind study with a primary endpoint of change from baseline in ISNCSCI upper extremity motor scores. Patients will be followed for a period of twelve months post enrollment.
Information about the Company's spinal cord injury program can be found on the
Information for patients interested in participating in the study is available at the Pathway website at:
Additional information about the clinical trial is available at:
About HuCNS-SC Cells
Apart from statements of historical fact, the text of this press release constitutes forward-looking statements within the meaning of the U.S. securities laws, and is subject to the safe harbors created therein. These statements include, but are not limited to, statements regarding whether the improvements in sensory function seen in the Company's Phase I/II clinical study of spinal cord injury will persist and whether they will prove to be clinically meaningful; 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 disorders; and the future business operations of the Company, including its ability to conduct clinical trials as well as its other research and product development efforts. 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 the FDA or other 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 recruit the patients required to conduct its clinical trials or to obtain meaningful results; uncertainties regarding the Company's ability to manufacture viable cells sufficient to enroll the patients planned for the Company's Phase II studies; 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
CONTACT: Greg Schiffman