Transplanted human spinal cord-derived neural stem cells may stabilize functioning in amyotrophic lateral sclerosis patients, according to a study in the Annals of Clinical and Translational Neurology.
Here are four things to know.
1. The Phase 1/2 study evaluated the impact of human spinal stem cell transplantation on functional outcomes as measured by the ALS Functional Rating Scale-Revised, a validated questionnaire that measures physical function in performing activities of daily living.
2. Biopharmaceutical company Neuralstem will use the data to design the Phase 2b/3 clinical study to further evaluate Neuralstem's cell therapy candidate NSI-566 for ALS patients. NSI-566 is a stem cell therapy being tested for the treatment of paralysis in stroke, ALS and chronic spinal cord injury.
3. The Phase 1 and 2 open label dose escalation studies were performed at the University of Michigan in Ann Arbor, Emory University in Atlanta and Harvard Medical School in Boston. The studies enrolled 30 subjects to assess the safety of intraspinal HSSC, while also measuring survival and functional endpoints.
4. According to the ALS Association, more than 6,000 people in the U.S. are diagnosed with ALS each year — 15 new cases each day — with approximately 20,000 Americans living with the progressive degenerative disease. There is currently no treatment to halt or reverse the disease's progression.
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