Adult mesenchymal stem cells are being tested in clinical trials in MS. The approach is similar to HSCT
, except that the individual’s immune cells are not destroyed or replaced. Instead, a person’s own mesenchymal stem cells are isolated from the bone marrow or blood stream and multiplied in the lab, and then re-introduced in greater numbers into their body. Only when the results of clinical trials are available will it be possible to determine what the optimal cells, delivery methods, safety and actual effectiveness of this experimental approach might be for people with MS.
Mesenchymal stem cells are being tested in several clinical trials including:
• Results were published
in February 2018 from a small, open label, phase I stem cell trial at the Tisch MS Research Center of New York. This trial used 20 individuals’own mesenchymal stem cells to derive more specific stem cells called “neural progenitor cells.” The cells were expanded in the laboratory and then injected into the space around the spinal cord (intrathecal). The goal was to inhibit immune mechanisms and to augment tissue repair.
The team reported mild to moderate headache and fever as the most common side effects, and for the primary outcome of the study, which was safety, they reported no serious adverse events. Although the study was not designed to determine potential benefits of this therapy, the team reported clinical observations including some improvements in EDSS scores, strength in some muscle groups, walking speeds and bladder symptoms. Larger, longer-term, controlled studies are needed to determine the safety and effectiveness of using this approach to treat MS.
The Tisch Center team announced intentions of following-up on this work by conducting a phase II trial of this therapy. The National MS Society is currently in discussions with the team to determine how the proposed phase II trial may be funded in an expedited fashion. THIS TRIAL IS NOT YET RECRUITING PARTICIPANTS.
• An international, placebo-controlled, phase II stem cell trial involving people with MS who show specific signs of inflammation and active disease, including people with primary progressive MS, secondary-progressive MS and relapsing-remitting MS, is getting underway at multiple sites in Europe and Canada. The “MESEMS” trial will test benefits and safety of using individuals’ own bone marrow cells, which are extracted and then given by intravenous infusion immediately or six months after extraction. The goal is to inhibit immune mechanisms and to augment tissue repair. THIS TRIAL IS BEGINNING TO RECRUIT PARTICIPANTS. GO TO THE MESEMS WEBSITE
FOR FURTHER INFORMATION ABOUT LOCATION AND CONTACT INFORMATION.
• A team from Israel’s Hadassah University Hospital is conducting a phase 2 clinical trial to establish the optimal way to administer mesenchymal stem cells in active, progressive MS. Participants are people with progressive MS with moderate to more severe disability (EDSS scale 3.5-6.5). They are administering the cells into the vein or the spinal fluid and then monitoring patients with various measures to try to detect a benefit and to find the best route for administering these cells. As of a report
given at a medical conference (ECTRIMS) in September 2016, of 39 enrolled people, they have not found serious adverse events, with the most common side effect being headache. This trial is ongoing
• A small, open label, phase I trial
of stem cells derived from placenta (known as “PDA-001” manufactured by Celgene Cellular Therapeutics) was completed in 2014, and results suggested this approach was safe. The study involved 16 people with relapsing-remitting or secondary-progressive MS at sites in the U.S. and Canada. This study was designed to evaluate safety and not designed to show effectiveness. In the published paper, the researchers comment that the next step, a proof-of-concept clinical trial, is planned. THIS PLANNED NEXT TRIAL IS NOT YET RECRUITING PARTICIPANTS.
• A placebo-controlled, phase II stem cell trial
involving people with secondary-progressive MS and primary progressive MS has begun at Frenchay Hospital in Bristol, United Kingdom, testing the benefits and safety of using individuals’ own bone marrow cells. The cells are extracted and then given by intravenous infusion immediately or one year after the extraction. The goal is to inhibit immune mechanisms and to augment tissue repair. THIS TRIAL IS RECRUITING PARTICIPANTS AT ONE SITE IN THE UNITED KINGDOM.
• A small, open-label, phase I clinical trial
at Cleveland Clinic tested the ability of an individual’s own mesenchymal stem cells to both inhibit immune mechanisms and to augment intrinsic tissue repair processes in people with relapsing forms of MS. They were given intravenously (infused into the vein). This study was led by Dr. Jeffrey A. Cohen and supported by the Congressionally Directed Medical Research Programs. The National MS Society provided support for a pilot study related to this trial to compare stem cells from people with MS and controls without MS, looking at how the cells survive and function, to enhance understanding from this stem cell trial. This trial, which was designed to evaluate safety and not designed to determine benefits, was completed and preliminary results were published
in April 2017, suggesting that this approach was safe and warrants a phase 2 trial, which is now in planning stages. THIS PLANNED TRIAL IS NOT YET RECRUITING ADDITIONAL PARTICIPANTS.
Larger, longer-term, controlled studies are needed to determine the safety and effectiveness of using stem cells to treat MS. When the results of these and subsequent clinical trials are available, it should be possible to determine what the optimal cells, delivery methods, safety and actual effectiveness of these current experimental therapies might be for different people with MS.
Read more about stem cell clinics.