Summary: Investigators in Ohio are recruiting 24 people with relapsing forms of MS for a study of the safety and tolerability of transplanting one’s own mesenchymal stem cells (derived from bone marrow). The study is being conducted at Cleveland Clinic Mellen MS Center, University Hospitals Case Medical Center, and the National Center for Stem Cell and Regenerative Medicine, all in Cleveland. This first trial of these cells for MS in the U.S. is supported by the Congressionally Directed Medical Research Programs, a program funded through the Defense Department, thanks in large part to the tireless work of MS activists across the country who helped to secure the funding. Please note: This study involves numerous visits to the study site.
Rationale: There are many types of stem cells, and varying degrees of research and knowledge about different types of stem cells and their potential usefulness for treating MS. At present, there has been no proven therapy for MS that uses stem cells. Read more about stem cells in MS.
One type of procedure that has been explored for several years in MS is called “autologous hematopoietic (blood cell-producing) stem cell transplantation.” This procedure has been used in attempts to “reboot” the immune system. These stem cells (derived from the bone marrow or blood) are stored, and the rest of the individual’s immune cells are destroyed by chemotherapy or radiation or both. Then the stored stem cells are reintroduced by injection. Eventually they grow and repopulate the body with immune cells. The hope of that as yet experimental procedure is that the new immune cells will no longer attack myelin or other brain tissue, so that the person has perhaps a completely new immune system.
Another line of stem cell research in MS relates to efforts to repair nervous system damage. This research is in its infancy, and there is no evidence yet that any types of stem cells can reverse MS damage or restore function. There are a few known research studies being conducted by researchers who are attempting in a controlled fashion to safely test the ability of mesenchymal stem cells to treat MS damage.
Mesenchymal stem cells, which are present in many tissues of the body, potentially have the ability both to treat immune disorders and promote tissue repair. This phase I clinical trial in Cleveland is testing the ability of an individual’s own mesenchymal stem cells isolated from the bone marrow to both inhibit immune mechanisms and to augment intrinsic tissue repair processes in people with relapsing forms of MS. Unlike previous bone marrow transplant studies, in this study the person’s immune cells are not destroyed before the stem cells are infused. This study is supported by the Congressionally Directed Medical Research Programs, a program funded through the Defense Department, thanks in large part to the tireless work of MS activists across the country who helped to secure the funding.
Eligibility and Details: Participants should be ages 18 to 55, and have a diagnosis of relapsing MS, with active disease during the previous 24 months. This study involves numerous criteria for including or excluding participants. Further details can be obtained from http://clinicaltrials.gov (search for study# NCT00813969) or the contacts below.
The treatment involves a single intravenous infusion of mesenchymal stem cells that have been previously removed from the participant’s bone marrow and expanded in the laboratory. The study involves several safety assessments, blood tests, neurologic assessments, MRI scans and others tests over six months.
The primary goal of the study is to determine the feasibility, safety and tolerability of the procedure. Secondary goals include assessing the effects on MS disease activity and severity, as measured by clinical, MRI, and other testing.
Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please contact:
Sarah Planchon Pope, PhD
Cynthia Schwanger, RN, MSCN, CCRP
Download a brochure that discusses issues to think about when considering enrolling in an MS clinical trial (PDF).