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StemCells, Inc. completes enrollment of first cohort in Phase 2 Pathway study for cervical spinal cord injury
04-17-2015
by Lloyd Dunlap  |  Email the author
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NEWARK, Calif.—In a study first announced in November 2014, StemCells, Inc., a leading stem cell company developing novel cell-based therapeutics for treating diseases of the central nervous system with high unmet medical need, announced today that it has completed transplanting the six patients comprising the first cohort of its Phase 2 Pathway study. The first cohort is an open- label dose escalation arm to determine the cell dose to be used for the second cohort of the study, which will be a single-blind arm in 40 patients that will assess efficacy of the company's proprietary HuCNS-SC® (purified human neural stem cells) platform technology for the treatment of cervical spinal cord injury.
 
StemCells’ Pathway study is reportedly 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 expansion of this trial into patients with cervical injury is exciting because even a gain of one to two segments in cervical spinal cord injury patients can allow for additional function in the upper extremities,” Greg Schiffman, chief financial officer of StemCells, told DDNews when the trial was announced.
 
"We are breaking new ground with this study," said Stephen Huhn, M.D., FACS, FAAP, vice president, CNS clinical research and CMO at StemCells, Inc. "This is the first controlled study to use neural stem cells with the intent to demonstrate improvement in motor function following spinal cord injury. In this first cohort, we have achieved the highest number of neural stem cells administered into the injured human spinal cord in medical history. We expect to release six month interim data on the first cohort later this year.
 
"Interest in this study from both physicians and patients has been very encouraging, resulting in the rapid enrollment of this cohort. The company is using web-based recruitment and, in the first six months, we have seen over 1,500 inquiries and 500 completed questionnaires and over 100 subjects have been reviewed for possible eligibility. Our experience with the first cohort reflects great clinical momentum, as well as the excitement within the spinal cord injury community for potential novel treatments. Detecting evidence of motor improvement in this Phase 2 study would provide proof-of-concept for this approach in spinal cord injury and would ultimately lead to a therapy that dramatically enhances the quality of life for those afflicted with spinal cord injuries."
 
The Pathway Phase 2 study, 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 stem cells (HuCNS-SC cells), into patients with traumatic injury in the cervical region of the spinal cord. Conducted as a randomized, controlled, single-blind study, the trial will measure efficacy 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 enroll approximately 52 subjects and follow the patients for 12 months post-transplant. 
 
StemCells, Inc. has demonstrated human safety data from completed and ongoing clinical studies in which its proprietary HuCNS-SC cells have been transplanted directly into all three components of the central nervous system: the brain, the spinal cord and the eye. StemCells, Inc. clinicians and scientists believe that HuCNS-SC cells may have broad therapeutic application for many diseases and disorders of the CNS. Because the transplanted HuCNS-SC cells have been shown to engraft and survive long-term, there is the possibility of a durable clinical effect following a single transplantation. The HuCNS-SC platform technology is a highly purified composition of human neural stem cells (tissue-derived or "adult" stem cells). Manufactured under cGMP standards, the company's HuCNS-SC cells are purified, expanded in culture, cryopreserved, and then stored as banks of cells, ready to be made into individual patient doses when needed. 
 
StemCells, Inc. is currently engaged in clinical development of its platform technology, HuCNS-SC (purified human neural stem cells) as a potential treatment for disorders of the central nervous system (CNS). Interim data from the Company's Phase 1/2 clinical trial in thoracic spinal cord injury (SCI) shows measurable gains involving multiple sensory modalities and segments, including 2 of 7 patients enrolled in the study with complete injuries (AIS A) converting to incomplete injuries (AIS B), post-transplant.
 
StemCells, Inc. has also completed enrollment and treatment in its Phase 1/2 clinical trial in geographic atrophy of age-related macular degeneration (GA-AMD), the most severe form of dry AMD, which is the leading cause of blindness in the elderly. Based upon interim results for subjects with twelve months data, the company reported a 70 percent reduction in the rate of disease progression as compared to the control (untreated) eye and a 65 percent reduction in the rate of disease progression as compared to the expected natural history of the disease. In a Phase 1 clinical trial in Pelizaeus-Merzbacher disease, a fatal myelination disorder in children, the company showed preliminary evidence of progressive and durable donor-derived myelination in all four patients transplanted with HuCNS-SC cells.
 
In a second, unrelated stem cell development, Takeda Pharmaceuticals, headquartered in Osaka, Japan, announced today that it will work together with the Center for iPS Cell Research Application (CiRA) of Kyoto University on stem cell research.

Dubbed the “Takeda-CiRA Joint Program for iPS Cell Applications” or T-CiRA, the collaboration will develop multiple research projects for drug discovery and cell therapy utilizing iPS cells for treatments for heart failure, diabetes, neurological disorders and cancer.
 
Code: E04171501

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