Preliminary Results For MS Stem Cell Trial Reveals Safety, Tolerability in Test Subjects
Tisch MS Research Center of New York (Tisch MSRCNY) researchers presented preliminary results from an FDA-approved Phase I trial, a small-scale investigation in humans using autologous neural stem cells for the treatment of multiple sclerosis (MS).
MS is an autoimmune disorder in which the body’s immune system launches an attack against myelin, the fatty substance that insulates nerve cells. When myelin is damaged in MS, problems with movement, sensation, pain and loss of vision can occur. The disease is unpredictable, and although treatments exist to delay progression somewhat, improved treatments are necessary and no cure exists.
The researchers used stem cells from the bone marrow of 20 participants with MS. Participants received injections of their own stem cells (autologous) into their cerebrospinal fluid, the liquid that surrounds the spinal cord and brain. This initial report focused on the first nine patients who have received a minimum of one treatment with stem cells.
The presentation of the results took place during the Multiple Sclerosis Highlights in the Field session at the 67th American Academy of Neurology (AAN) Annual Meeting in Washington, D.C. In the interim analysis, six out of nine patients had increased motor strength, improved bladder function and a better quality of life. So far, patients have not experienced any serious side effects.
“This preliminary data is encouraging because in addition to helping establish safety and tolerability, the trial is yielding some positive therapeutic results even at this early stage,” remarked Dr. Saud A. Sadiq, Chief Research Scientist at Tisch MSRCNY and the study’s principal investigator.
One of the participants, Vicky Gill, who is a mother of two and whose husband also has MS stated: “For the past six years, I would fall frequently, had very limited movement in my legs and always walked with my cane. After just two stem cell treatments, I am now gaining sensation and function I thought was totally lost, have not had any recent falls and at times don’t need a cane at all.”
People participating in the study will receive a total of three rounds of injections, given every three months. Researchers will assess both the effectiveness of the treatment, as well as its safety. If the study meets the criteria for success during this initial Phase I, researchers plan to proceed to Phase II trials.
The US Food and Drug Administration (FDA) requires three completed clinical Phases for a treatment to be approved for general use. To learn more about clinical trials and how they function, visit the MS News Today Clinical Trial Participation Guide.
For more information on this study contact Tisch MSRCNY.