NIH Stem Cell Trial Review

by Dr. James W. Stark

1/8/15 - The December 29th online issue of the journal, JAMA Neurology, published results on the safety and efficacy of a stem cell project currently funded by the National Institute of Health (NIH). This is valuable research in the field of Multiple Sclerosis, but is NOT the same as the phase I REPARATIVE stem cell trial currently underway at the IMSMP.

The NIH study examined 25 patients with early relapsing-remitting MS who had evidence of disease activity on standard MS treatments. Following bone marrow/stem cell collection, the patients were given high-dose chemotherapy to ‘erase’ their immune system. The patients’ own stem cells were then returned to the patients in the hope of ‘resetting’ their immune system. The goal is that whatever is the immune-driving force in MS, it would not be present in the ‘new’ immune system. The results are encouraging, in that nearly 80% of patients did not show evidence of disease activity over three years, despite that these patients were not treated with other MS drugs afterwards. While there were safety concerns with the high-dose chemotherapy, patients in this trial had fewer adverse events than in previous similar trials. In other trials using this type of protocol, there have been a number of more serious safety issues, including patient death.

These results are promising for early relapsing-remitting MS patients, who are unresponsive to initial medications. This treatment may be appropriate for the few MS patients that present with an unusually aggressive form of this disease. Based on this data, this treatment may stabilize aggressively presenting patients’ condition for up to three years; however this is not a cure for their MS.

The phase I stem cell project at the IMSMP is different from this one in that our study uses stem cells (and not chemotherapy) in an effort to REPAIR the damage that has already occurred in MS and not necessarily to prevent further worsening in relapsing-remitting patients. Our current armamentarium of MS treatments is very effective at disease stabilization in the majority of newly diagnosed RRMS patients. Although there are certainly safety concerns with many of the newer MS treatments, they are less worrisome than the potential safety issues thus far with this type of procedure, for the vast majority of patients.

We will be closely following this research to provide our patients with the best possible MS care, as well as to learn more about the role of stem cells in the body and in MS.

 

News Date : 
Thursday, January 8, 2015 - 19:43

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