MS STEM CELL TREATMENT FULL

I am less familiar with the commercial space for cell therapy in MS, but it is most likely hindered by the high cost of treatment, lack of standardization, and regulatory hurdles associated with biological licensing. Good phase 2 data is complicated by the fact that MS is a heterogenous disease, and we lack good clinical outcomes or surrogate markers for progressive MS. Very few phase 2 studies have been conducted, so we really need more data from larger trials to show efficacy. Regarding mesenchymal stem cell-based therapies, multiple early-stage clinical studies have been performed with encouraging data but small sample sizes. Harris: Translation of stem cell technology to patients with MS has been frustratingly slow. Are there already commercial applications? MHE: Describe the progress in stem cell research globally and the implications for treating MS. In line with the goal of treatment optimization, we are particularly excited about our biomarker research, which would allow us to predict which patients are most likely to respond to cell therapy based on their biomarker profile. Our goal is to optimize cell therapy for progressive MS patients, which may require higher doses in some patients in order to achieve clinical benefit.

MS STEM CELL TREATMENT FULL

We are currently completing the final stages of the trial and anticipate a full data analysis completed by the end of this year.īased on the preliminary analysis, we are starting discussions with the FDA to explore whether a dose escalation trial is warranted for the more disabled patients who did not respond to stem cell treatment. While we did observe encouraging trends of improvement in patients treated with stem cells, it must be emphasized that a full data analysis with comparison with the placebo arm remains to be completed to determine whether trends in efficacy are statistically significant. Harris: We are conducting a phase 2 double-blind, placebo-controlled clinical trial testing the efficacy of autologous mesenchymal stem cell neural progenitors (MSC-NPs) administered into the spinal fluid (intrathecally) of patients with SPMS and PPMS. MHE: Please discuss the significance of the Center’s interim stem cell treatment trials, and the next steps in this research. Harris not only discussed the stem cell treatment research, but also other promising MS discoveries. Managed Healthcare Executive® spoke with Violaine Harris, Ph.D., a senior research scientist with Tisch MS Research Center of New York who is also closely involved with the stem cell treatment study.

Ms stem cell treatment