Mesenchymal Stem Cell Therapy Trial for Multiple Sclerosis
The first Canadian clinical trial to explore mesenchymal stem cell therapy for multiple sclerosis is now underway with the help of a $4.2 million grant. This groundbreaking effort is under the direction of Mark S. Freedman, MD, of the University of Ottawa and The Ottawa Hospital.
Mesenchymal stem cell therapy is one of two types of stem cell therapy that has been under investigation for treatment of multiple sclerosis. The other type is called hematopoietic stem cell therapy, and both have demonstrated varying degrees of benefit for MS patients.
Although the two types of stem cell therapy have some significant differences, one of special importance is the fact that patients undergoing hematopoietic stem cell transplantation must first undergo extensive chemotherapy to eliminate an individual’s defective immune system. This places patients at significant risk of infection. Mesenchymal stem cell therapy does not require this step.
What is mesenchymal stem cell therapy?
Mesenchymal stem cells are derived from adult bone marrow, skin and fat tissue, and umbilical cord blood. This therapy is still in the experimental stages and is being studied in multiple sclerosis for their ability to reduce inflammation, support the immune system, and help prevent and repair tissue damage.
This therapeutic approach involves extracting mesenchymal stem cells from a patient’s own bone marrow and expanding them for several week in a specialized culture lab. The cells are frozen and then thawed before they are infused back into the same patient via an intravenous line.
In hematopoietic stem cell therapy, the cells are harvested from the bone marrow or blood. This approach, in contrast to mesenchymal stem cell therapy, attempts to restart the immune system by giving patients their own stem cells back after they have been purified and their immune system has been wiped clean via chemotherapy.
Ongoing mesenchymal stem cell trial
The ongoing trial is called MESCAMS (Mesenchymal Stem cell therapy for Canadian MS patients). The investigators are enrolling 40 individuals (aged 18 to 50) with either relapsing-remitting MS that has not responded to at least one existing therapy, as well as individuals with secondary and primary progressive MS who have active disease.
The trial is also taking place at Health Sciences Centre Winnipeg, which will enroll 20 of the 40 planned participants. MESCAMS represents about one-quarter of an international collaboration that also includes Genoa, Italy.
Individuals chosen to participate in the double-blind, placebo-controlled clinical trial will be randomly assigned to one of two groups. One group will be treated with their mesenchymal stem cells soon after they are harvested, treated in the laboratory, and frozen. The second group will be given a placebo solution and then receive their previously frozen stem cells six months later.
Other mesenchymal stem cell studies
The results of a small (8 patients) placebo-controlled clinical trial were recently published in PLoS One. Five patients were initially treated with their own stem cells, and six months later the remaining three, who were given placebo initially, were treated.
The authors reported a trend to a reduced cumulative number of gadolinium-enhancing lesions after six months and at one year. However, they did not observe any significant differences in relapses and disability.
At Icahn School of Medicine at Mount Sinai, a research team used a preparation of cultured mesenchymal stem cells (from placenta) and administered them to 12 individuals with multiple sclerosis: six with relapsing-remitting MS and six with secondary progressive MS. Four additional patients were given placebo.
Magnetic resonance imaging scans were conducted over the next six months to check for any change in brain lesions. None of the participants showed any worsening in brain lesions, and most of them either stabilized or had some improvement in disability level after one year.
The estimated completion date of the current clinical trial is September 2016. Right now there are several other clinical trials either recruiting or underway using mesenchymal stem cell therapy for multiple sclerosis—search ClinicalTrials.gov. Interested individuals should talk to their neurologist about whether they might qualify for any current or future research studies.