Interim Data to be Presented at Upcoming American Spinal Injury Association Conference
NEWARK, CA, USA I April 17, 2014 I StemCells, Inc. (Nasdaq:STEM) announced today that it has completed enrollment in the Company’s Phase I/II clinical trial in spinal cord injury. The multi-national, open-label, Phase I/II trial is evaluating both safety and preliminary efficacy of StemCells, Inc.’s proprietary HuCNS-SC® human neural stem cells as a treatment for chronic spinal cord injury. The trial enrolled twelve subjects with chest-level injury to the spinal cord. The trial enrolled seven patients with complete paralysis, no motor or sensory function below the point of injury, classified as complete (AIS A), according to the American Spinal Injury Association Impairment Scale, and five patients with no motor function and limited sensory function below the point of injury classified as incomplete (AIS B). Zurich study site principal investigator, Dr. Armin Curt, will present an interim update based on six month data for the first six subjects at the American Spinal Injury Association conference this coming May. Final results from this landmark study are expected to be released mid-2015.
“This is the first clinical trial evaluating stem cell transplantation in spinal cord injury to successfully complete enrollment. Successful dosing of all subjects in the trial is a major accomplishment for the field and the spinal cord injury program at StemCells, Inc.,” said Stephen Huhn, M.D., FACS, FAAP, Vice President, CNS Clinical Research at StemCells, Inc.
“I have the utmost respect for all of the brave patients, their families and caregivers who have been open to participating in this study. There is a large unmet medical need for patients suffering from spinal cord injury, and completion of all transplantations in this trial signifies an important inflection point in the pace of our development. This clinical research milestone moves us one step closer to our goal of developing a first in class therapy for this indication based on our proprietary HuCNS-SC platform technology.”
The study, initiated at the University of Zurich under Dr. Armin Curt, subsequently expanded to include two sites in Canada and also received an Investigational New Drug (IND) authorization from the U.S Food and Drug Administration (FDA).
“Having been involved with this trial from the very beginning, I have a sense that the research is now starting to accelerate and we are very pleased to have played a role in this groundbreaking trial,” said Armin Curt, MD, the principal investigator at the University of Zurich.
Steve Casha, M.D., Ph.D., FRCSC, the principal investigator at the University of Calgary, added, “We completed the surgical transplantation of the final patient yesterday and clinical studies like this one are very important to patients affected by spinal cord injury. I am very excited by the prospect of participating in the next phase of clinical research where the goal is to demonstrate efficacy in a Phase II placebo controlled clinical trial.”
About the StemCells, Inc. Spinal Cord Injury Clinical Trial
The Company’s Phase I/II clinical trial is designed to assess both 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 or incomplete according to the American Spinal Injury Association Impairment Scale.
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 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 University of Calgary, the University of Toronto, and University of Zurich’s Balgrist University Hospital, world-leading medical centers for spinal cord injury and rehabilitation.
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 have been, and will continue to be, performed regularly throughout 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 will be 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 trial designed to measure efficacy in cervical spinal cord injury in 2014.
Information about the Company’s Spinal Cord Injury program can be found on the StemCells, Inc. website at:
http://www.stemcellsinc.com/Therapeutic-Programs/Spinal-Cord-Injury.htm
About StemCells, Inc.
StemCells, Inc. is engaged in the research, development, and commercialization of cell-based therapeutics and tools for use in stem cell-based research and drug discovery. The Company’s lead therapeutic product candidate, HuCNS-SC® cells (purified human neural stem cells), is currently in development as a potential treatment for a broad range of central nervous system disorders. In a Phase I clinical trial in Pelizaeus-Merzbacher disease (PMD), a fatal myelination disorder in children, the Company has shown preliminary evidence of progressive and durable donor-derived myelination in all four patients transplanted with HuCNS-SC cells. The Company conducted a Phase I/II clinical trial in chronic spinal cord injury in Switzerland, Canada and the United States, and has reported positive interim data for the first three patients. The Company is also conducting a Phase I/II clinical trial in dry age-related macular degeneration (AMD) in the United States. In addition, the Company is pursuing preclinical studies in Alzheimer’s disease, with support from the California Institute for Regenerative Medicine (CIRM). StemCells also markets stem cell research products, including media and reagents, under the SC Proven® brand. Further information about StemCells is available at http://www.stemcellsinc.com.
SOURCE: Stem Cells
Post Views: 269
Interim Data to be Presented at Upcoming American Spinal Injury Association Conference
NEWARK, CA, USA I April 17, 2014 I StemCells, Inc. (Nasdaq:STEM) announced today that it has completed enrollment in the Company’s Phase I/II clinical trial in spinal cord injury. The multi-national, open-label, Phase I/II trial is evaluating both safety and preliminary efficacy of StemCells, Inc.’s proprietary HuCNS-SC® human neural stem cells as a treatment for chronic spinal cord injury. The trial enrolled twelve subjects with chest-level injury to the spinal cord. The trial enrolled seven patients with complete paralysis, no motor or sensory function below the point of injury, classified as complete (AIS A), according to the American Spinal Injury Association Impairment Scale, and five patients with no motor function and limited sensory function below the point of injury classified as incomplete (AIS B). Zurich study site principal investigator, Dr. Armin Curt, will present an interim update based on six month data for the first six subjects at the American Spinal Injury Association conference this coming May. Final results from this landmark study are expected to be released mid-2015.
“This is the first clinical trial evaluating stem cell transplantation in spinal cord injury to successfully complete enrollment. Successful dosing of all subjects in the trial is a major accomplishment for the field and the spinal cord injury program at StemCells, Inc.,” said Stephen Huhn, M.D., FACS, FAAP, Vice President, CNS Clinical Research at StemCells, Inc.
“I have the utmost respect for all of the brave patients, their families and caregivers who have been open to participating in this study. There is a large unmet medical need for patients suffering from spinal cord injury, and completion of all transplantations in this trial signifies an important inflection point in the pace of our development. This clinical research milestone moves us one step closer to our goal of developing a first in class therapy for this indication based on our proprietary HuCNS-SC platform technology.”
The study, initiated at the University of Zurich under Dr. Armin Curt, subsequently expanded to include two sites in Canada and also received an Investigational New Drug (IND) authorization from the U.S Food and Drug Administration (FDA).
“Having been involved with this trial from the very beginning, I have a sense that the research is now starting to accelerate and we are very pleased to have played a role in this groundbreaking trial,” said Armin Curt, MD, the principal investigator at the University of Zurich.
Steve Casha, M.D., Ph.D., FRCSC, the principal investigator at the University of Calgary, added, “We completed the surgical transplantation of the final patient yesterday and clinical studies like this one are very important to patients affected by spinal cord injury. I am very excited by the prospect of participating in the next phase of clinical research where the goal is to demonstrate efficacy in a Phase II placebo controlled clinical trial.”
About the StemCells, Inc. Spinal Cord Injury Clinical Trial
The Company’s Phase I/II clinical trial is designed to assess both 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 or incomplete according to the American Spinal Injury Association Impairment Scale.
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 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 University of Calgary, the University of Toronto, and University of Zurich’s Balgrist University Hospital, world-leading medical centers for spinal cord injury and rehabilitation.
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 have been, and will continue to be, performed regularly throughout 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 will be 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 trial designed to measure efficacy in cervical spinal cord injury in 2014.
Information about the Company’s Spinal Cord Injury program can be found on the StemCells, Inc. website at:
http://www.stemcellsinc.com/Therapeutic-Programs/Spinal-Cord-Injury.htm
About StemCells, Inc.
StemCells, Inc. is engaged in the research, development, and commercialization of cell-based therapeutics and tools for use in stem cell-based research and drug discovery. The Company’s lead therapeutic product candidate, HuCNS-SC® cells (purified human neural stem cells), is currently in development as a potential treatment for a broad range of central nervous system disorders. In a Phase I clinical trial in Pelizaeus-Merzbacher disease (PMD), a fatal myelination disorder in children, the Company has shown preliminary evidence of progressive and durable donor-derived myelination in all four patients transplanted with HuCNS-SC cells. The Company conducted a Phase I/II clinical trial in chronic spinal cord injury in Switzerland, Canada and the United States, and has reported positive interim data for the first three patients. The Company is also conducting a Phase I/II clinical trial in dry age-related macular degeneration (AMD) in the United States. In addition, the Company is pursuing preclinical studies in Alzheimer’s disease, with support from the California Institute for Regenerative Medicine (CIRM). StemCells also markets stem cell research products, including media and reagents, under the SC Proven® brand. Further information about StemCells is available at http://www.stemcellsinc.com.
SOURCE: Stem Cells
Post Views: 269
