Human Stem Cell Trials for SCI Therapy Approved for U.S. by FDA

Oct 22, 2013

What can we expect from the first U.S. human clinical trials of stem cell therapy for spinal cord injury (SCI)?

In an exciting development, StemCells, Inc., has announced that it has received FDA authorization to begin clinical trials of its Investigational New Drug (IND) application of purified stem cell therapy to treat chronic spinal cord injury. This means that the breakthrough therapy for stem cell injuries can now begin testing on human patients in the United States.

The company, which focuses on the research and development of therapies and tools for use in stem-cell-based research, began trials about a year ago in Switzerland and Canada, and sees the potential breakthrough therapy currently being tested on a total of seven patients in those countries. The company calls the therapy HuCNS-SC, which stands for human neural stem cells.

Research for the therapy has been ongoing since 2002, when pre-clinical studies conducted with researchers at the University of California, Irvine showed that human neural stem cells engraft long-term, migrate to the area of injury, and transform themselves into specialized cells that create the protein myelin, a vital substance in treating spinal cord injury. The research eventually showed that transplantation of human neural stem cells can restore lost motor function. This restoration of function occurs even when treatment is administered after the initial, acute phase of injury.

The FDA approval for human clinical trials is a highly anticipated next stage.

This IND is a significant step forward for our spinal cord injury program, said Stephen Huhn, MD, FACS, FFAP, the companys VP of CNS Clinical Research. With regulatory authorization from Switzerland, Canada, and now the United States, we have the first international trial of a stem cell therapy for spinal cord injury. He goes on to say, We now look forward to enrolling patients at U.S. and Canadian sites and easing the travel burden for North American patients.

Read this article:
Human Stem Cell Trials for SCI Therapy Approved for U.S. by FDA