Stem Cells Inc. Reports Positive Safety Data in Their Spinal Cord Injury Trial With Human Neural Stem Cells


StemCells, Inc., a biotechnology company based in Newark, California, has reported the results of their initial safety review of their human purified neural stem cell line implantations. This report represents the first planned interim safety review of the Company’s Phase I/II spinal cord injury clinical trial. This clinical trial involved a surgical implantation of the stem cells, and suppression of the immune system with anti-rejection drugs. The results of the safety trial show that both parts of the procedures seem to be well tolerated.

This trial was designed to determine the safety and potential, efficacy of the StemCells, Inc. proprietary HuCNS-SC® cells in spinal cord injury patients. HuCNS-SC cells are a purified human neural stem cell line that can form all the cells of the central nervous system (Taupin P. Curr Opin Mol Ther. 2006;8(2):156-63). When these cells are implanted into the retinas for rats that are suffering from retinal degeneration, they form a variety of retinal-specific cell types and seem to aid in retinal regeneration (McGill TJ., et al., Eur J Neurosci. 2012;35(3):468-77).

This clinical trial represents the first time that human neural stem cells have been implanted into the spinal cords of human patients as a potential therapeutic agent for spinal cord injury. The interim data come from the first cohort of patients. All of these first cohort patients suffered a complete spinal cord injury, and show no neurological function below the level of the injury.

All patients in the trial were transplanted with 20 million neural stem cells at the site of injury in the thoracic spinal cord. Observation of the patients revealed that there were no detectable abnormal responses to the cells, and all the patients were neurologically stable through the first four months following transplantation of the cells. Changes in sensitivity to touch were observed in two of the patients. These data merit the continuance of the trial, and further enrollments. Patients with partial spinal cord injuries, who might experience a broader range of improvements are also being sought for enrollment.

Armin Curt, M.D., principal investigator for the clinical trial, said, “We are very encouraged by the interim safety outcomes for the first cohort.”  Dr. Curt is Professor and Chairman of the Spinal Cord Injury Center at the University of Zurich, and Medical Director of the Paraplegic Center at Balgrist University Hospital. Dr. Curt continued, “The patients in the trial are being closely monitored and undergo frequent clinical examinations, radiological assessments by MRI and sophisticated electrophysiology testing of spinal cord function. The comprehensive battery of tests provides important safety data and is very reassuring as we progress to the next stage of the trial.”

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mburatov

Professor of Biochemistry at Spring Arbor University (SAU) in Spring Arbor, MI. Have been at SAU since 1999. Author of The Stem Cell Epistles. Before that I was a postdoctoral research fellow at the University of Pennsylvania in Philadelphia, PA (1997-1999), and Sussex University, Falmer, UK (1994-1997). I studied Cell and Developmental Biology at UC Irvine (PhD 1994), and Microbiology at UC Davis (MA 1986, BS 1984).