Lesser or stable disability over two years was evident in most progressive multiple sclerosis (MS) patients given a stem cell treatment in a small Phase 1 clinical trial, supporting a larger study now underway, researchers report.
These results suggest that a treatment using mesenchymal stem cell-derived neural progenitors (MSC-NPs) can safely and effectively ease inflammation in progressive MS.
But for a subset of patients, particularly those with more advanced disease and greater disability, this treatment did not sufficiently counter a continued inflammatory response in the brain.
The study, “Mesenchymal stem cell-derived neural progenitors in progressive MS: Two-year follow-up of a phase I study,” was published in the journal Neurology: Neuroimmunology and Neuroinflammation.
MSC-NPs are seen as a possible way of treating people with progressive MS, who have few effective disease-modifying treatments available. They are essentially stem cells collected from a patient’s bone marrow that are expanded and matured to produce factors involved in modulating the immune response and in nervous tissue growth and survival.
An open-label Phase 1 trial (NCT01933802) investigated this stem cell treatment in 20 adults with stable primary (four PPMS patients) or secondary progressive MS (16 SPMS patients) and significant disability.
All received a total of three injections of MSC-NPs, given directly into the spinal canal three months apart. They were then evaluated at three and six months, and again at two years, after the final treatment to determine its long-term safety and tolerability, and for signs of potential effectiveness.
An initial analysis at six months post-treatment found lesser disability in most trial participants (15 of the 20) and better muscle strength in 14 of them. Greater exercise capacity was also seen in four of the 10 patients able to walk at the study’s start, and two nonambulatory patients gained an ability to walk using assistive devices.
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