- What is Tisch MSRCNY?
- Stem Cell Trial
- Team Tisch MS
- Get Involved
Our Phase I stem cell trial results were recently published in EBioMedicine and because of the encouraging data Phase II of our study has commenced. Our Phase I study began in 2014, 20 patients were enrolled, and all 20 patients received 3 treatments of mesenchymal stem cell neural progenitors (MSC-NPs) each given 3 months apart from one another. By 2016, the treatment portion of Phase I concluded, with no serious adverse events reported. 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.
With Phase I proving to be safe and well tolerated, the FDA gave Tisch MSRCNY the greenlight to go ahead with our plans for Phase II. Phase II consists 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 that we will hopefully prove that MSC-NPs are an efficacious treatment option for MS patients with disability.
In anticipation of this endeavor, Tisch MSRCNY began plans to build a technologically advanced stem cell lab to handle the increased volume of patients and the stringent requirements involved in manufacturing their stem cells. The new $5 million Regenerative Medicine Laboratory is now complete and operational.
We appreciate your support as we continue to raise the additional $4 million needed to fund Phase II.