- What's Tisch?
- Stem Cell Trial
- Team Tisch
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With the phased clinical testing of autologous stem cells, our goal is to determine the safety and efficacy of this novel treatment in people with progressive MS. Our Phase I study began in 2014, 20 patients were enrolled, and all 20 patients received 3 intrathecal treatments of mesenchymal stem cell neural progenitors (MSC-NPs) each given 3 months apart from one another. The results of the Phase I clinical trial demonstrated that there were no serious adverse events associated with this treatment. In addition to proving MSC-NP treatment to be safe, we were encouraged by signs of efficacy from this therapy. Three months after study patients received their final stem cell treatment, 75% of them demonstrated physical improvements upon neurological examination and testing.
In our Phase I two-year follow up study, our clinical team monitored the Phase I patients for two additional years after their treatment. Our results showed that there were no long-term side effects from the MSC-NP therapy. Importantly, a subset of patients showed sustained clinical improvement two years after treatment. These encouraging findings suggest that some of the clinical benefits of MSC-NP may be long-lasting.
With Phase I proving to be safe and well tolerated, the FDA gave Tisch MSRCNY the greenlight to go ahead with a Phase II clinical trial, consisting of 50 patients receiving stem cells in a placebo-controlled double-blind study. This means neither the patient nor the assessing neurologist will know whether or not the patient received a stem cell treatment or placebo. The study has a crossover design, meaning that study patients who received a placebo in the first year will crossover into the MSC-NP treatment group in the second year (and vice versa). The goal is to prove that MSC-NPs are an efficacious treatment option for MS patients with disability. The Phase II trial is fully enrolled and well underway. Initial trial results are expected to be announced in the first half of 2022.
The Phase II trial is supported in part by generous funding from the National MS Society and from Biogen. We appreciate the continued support of individual donors to help us fund the trial in its entirety.