Stem Cell for Multiple Sclerosis Trials in Canada. The MS Clinic at HSC Winnipeg and the Ottawa MS Clinic will be conducting clinical trials to look into the use of mesenchymal stem cells to treat multiple sclerosis. The trials will be conducted in the cities of Winnipeg, MB and Ottawa, ON.
Our Canadian readers who would like to participate in these two trials may want to email Stemcells_MS@hsc.mb.ca to express your interest. You can also contact them at 204-787-4778.
Those of you who have some questions about this trials might find your answers in this FAQ courtesy of hsc.mb.ca:
Q: What are mesenchymal stem cells?
A: Mesenchymal stem cells (MSC) – found in many places in the body including the bone marrow, skin and fat – have been demonstrated to suppress inflammation and repair nerve tissue, positioning them as promising candidates for the treatment of multiple sclerosis (MS).
Q: What is the MESCAMS study?
A: MESCAMS is the Canadian arm of an international study investigating the safety and efficacy of MSC therapy for MS. MESCAMS is a phase II, randomized, double-blind, placebo-controlled cross-over study that will take place at two Canadian sites – The Ottawa Hospital and Health Sciences Centre (HSC) Winnipeg
Study participants will receive either an early intravenous treatment of their own MSC extracted from their bone marrow, or a mock solution. At 24 weeks the reverse will occur, meaning that those that those who received the MSC initially will get the mock solution and those who started with the mock solution will get their MSC. Treatment safety and ability to reduce inflammation as measured by MRI will be observed at 24 weeks, and all participants will be followed for a total of 48 weeks.
Q: What will the treatment entail?
A: All participants will have 20 ml of bone marrow extracted from the hip bone under local anesthesia. MSC will then be isolated from the bone marrow and multiplied over a period of approximately three weeks at highly specialized laboratories in Ottawa and Winnipeg, then frozen down. Participants will be randomly assigned to receive a single infusion of either their own MSC or a mock solution at week zero. At 24 weeks, participants will cross over to the opposite treatment arm (i.e., at the end of week 24, those who initially received their MSC will receive the mock solution and vice versa).
Q: What are the risks of the treatment?
A: All potential and unknown risks and complications associated with the treatment will be explained to each participant before they make a decision about participating in the study. Only minimal risks have been identified by the principal investigators as being associated with this treatment. Common complications that may occur from the removal of bone marrow include pain during and after the procedure as well as bleeding and infection at the puncture site (where the needle goes in). With the IV infusion of MSC or placebo, individuals may experience fever, chills and rigors.
In order to freeze down and preserve the integrity of the MSC, a chemical called dimethylsulfoxide (DMSO) is used. DMSO is commonly used in the field of blood and marrow stem cell transplantation as a preservative. When individuals undergo the MSC or mock infusion they will receive a small amount of DMSO. The most common side effects associated with DMSO administration include a mild drop or rise in heart rate and headache. Other rare side effects associated with DMSO administration may occur and will be explained in detail to each potential participant prior to providing informed consent.
Q: How is MESCAMS different from the previously conducted stem cell trial in Canada?
A: This will be the first Canadian study evaluating the safety and benefit of mesenchymal stem cell therapy for multiple sclerosis. Unlike previous studies involving transplantation of hematopoietic stem cells chemotherapy (which often has serious side effects) will not be required.
Q: Who will be eligible to participate in MESCAMS?
Male and female adults aged 18-50 diagnosed with multiple sclerosis:
Relapsing-remitting MS who have not responded to at least 1 year of therapy with one or more of the approved disease modifying therapies as evidenced by at least one of the following:
- One or more clinically documented relapse in the past 12 months
- Two or more clinically documented relapses in past 24 months
- One or more gadolinium-enhancing lesion as seen on MRI within the past 12 months
Secondary-progressive MS with both of the following:
- an increase of one or more EDSS point in the past 12 months
- one or more clinically documented relapse or one or more gadolinium-enhancing lesion as seen on MRI within the past 12 months
Primary progressive MS with all of the following:
- an increase of one or more EDSS point in the past 12 months
- one or more gadolinium-enhancing lesion as seen on MRI within the past 12 months
positive cerebrospinal fluid (CSF)
- Diagnosed with multiple sclerosis for 2-10 years.
- EDSS score of 3.0 to 6.5.
This is not the complete list of inclusion criteria. For full inclusion and exclusion information please visit ClinicalTrials.gov
Q: Who do I contact if I want to be considered as a participant in MESCAMS?
A: Please email us at Stemcells_MS@hsc.mb.ca. You may also call our research office at 204-787-4778. Please do not call the MS Clinic as we are caring for patients. Due to the high amount of interest in this trial, we will not be able to answer individual calls or emails; however we will record your interest in this trial. Only those who meet the screening criteria above will be considered for participation.
Q: How many participants will be accepted at the Winnipeg site?
A: The Winnipeg and Ottawa sites will each enroll 20 participants.
Q: Can people from out of province participate at the Winnipeg site?
A: The Winnipeg site is accepting participants from within Manitoba only. The Ottawa site will be accepting participants from out of province; however participants will be required to cover the cost of travel and relocating to Ottawa for the entire duration of the trial as the study visits are frequent and the required assessments at each of these visits are quite intensive.
Q: When will patients be contacted to participate?
A: The MS Clinic at HSC will be contacting patients who have indicated their interest in clinical research studies and who may meet the study criteria. We anticipate that screening will begin early in 2015.