The International Cellular Medicine Society’s (ICMS) Institutional Review Board (IRB), headquartered in Salem, Ore, recently approved a new study utilizing neural stem cells for multiple sclerosis (MS). The joint announcement of the study’s approval was recently made by the Multiple Sclerosis Research Center of New York (MSRCNY), New York, NY, and the ICMS.
The study will explore a regenerative strategy encompassing the use of mesenchymal stem cell-derived neural progenitor cells. Prior research conducted at the MSRCNY has indicated that the injection of these cells may decrease inflammation in the central nervous system (CNS) and promote myelin repair and/or neuroprotection.
According to researchers, these cells will be harvested from the patient’s own bone marrow and injected into the cerebral spinal fluid surrounding the spinal cord. Researchers say 20 participants with a confirmed diagnosis of MS will receive the injections.
A recent news release calls the research an open label safety and tolerability study. The release adds that all participants will be enrolled in the study via the MSCRNY. The study itself will reportedly be conducted at the MSRCNY and affiliated International Multiple Sclerosis Management Practice (IMSMP).
Researchers report that during the study’s 3-year duration, participants will undergo a single bone marrow collection procedure. Following the collection, neural progenitor cells will be isolated, expanded and tested prior to patient injection. Scheduled follow-up visits will allow researchers to evaluate safety and efficacy parameters in patients.
The team of medical doctors, researchers, and non-scientific community members that comprise the ICMS IRB reviewed the treatment protocols, informed consents, and the inclusion/exclusion of the criteria for the study at its November meeting. David Audley, executive director and CEO of the ICMS explains that, “The main purpose of the IRB is to evaluate the safety of the therapy. After reviewing the study and all supporting materials, we were convinced that the therapy was not going to put the patients at undue risk, and that the treatment itself is the practice of medicine,” Audley says.
Saud A. Sadiq, MD, neurologist and director of the MSRCNY, adds that the initial stem cell treatment opens up new avenues of treatment options that target regeneration and repair. “We are delighted that the ICMS has approved our study and feel both the MSRCNY and the ICMS share the basic ideology of advancing safe and effective treatment in addressing patient needs,” Sadiq says.
Sadiq also adds that the team is entering a whole new world of possibilities for MS patients.