Medical Update Memo
Revised May 10, 2002
(Originally Issued, Sept. 12, 2000)
The first four participants treated to date in the bone marrow transplantation study have come through the procedure safely. The Multiple Sclerosis Scientific Research Foundation is funding a multi-centre project to determine definitively whether transplanting bone marrow stem cells in people with MS can stop the disease. Led by Dr. Mark Freedman (MS neurologist) and Dr. Harold Atkins (bone marrow transplant physician), both at the University of Ottawa, the study involves 32 people with rapidly progressing multiple sclerosis who are likely to become severely disabled. Twenty-four of the participants will receive bone marrow transplantation while eight other people with the same kind of MS but who do not wish to have the procedure will be the control group. Recruitment began in October 2000. The MS Scientific Research Foundation is related to the Multiple Sclerosis Society of Canada, and receives more than 95% of its funding from the MS Society. This project is funded for $4 million over six years.
At the recent meeting of the American Academy of Neurology, Dr. Mark Freedman reported on the safety outcomes for the initial four people who have received bone marrow transplantation.
Bone marrow transplantation is used frequently to treat leukemia. In a very small number of people who have both MS and leukemia, it has been noted that their MS improved following the bone marrow stem cells transplant. This project should allow investigators to determine if bone marrow transplantation is an effective treatment in a group of closely matched people with MS, supporting the theories that the immune system is key to the disease. Equally important, should the procedure not fully stop the disease process, the researchers may be able to detect what triggers MS early on and discover how MS begins. They are being monitored closely for any signs of disease activity in the participants at all stages of the procedure from enrolment to end of study six years from now. Monitoring includes: complex immune system tests and the tracking of certain immune-related genetic changes in the hope of unveiling particular genes that might contribute to genetic susceptibility.
The study is headed by Dr. Mark Freedman and Dr. Harold Atkins of The Ottawa Hospital and the University of Ottawa. Co-investigators include Dr. Jack Antel, Dr. Yves Lapierre, Dr. Amit Bar-Or and Dr. Douglas Arnold, Montreal Neurological Institute and McGill University; Dr. Pierre Laneuville, Royal Victoria Hospital and McGill University; Dr. Pierre Duquette, Notre-Dame Hospital and the University of Montreal; Dr. Rafick Sekaly, University of Montreal; Dr. Hans Messner, Princess Margaret Hospital and the University of Toronto; Dr. Paul O'Connor, St. Michael's Hospital and the University of Toronto; Dr. Isabelle Bence-Bruckler and Dr. Lothar Huebsch, both at The Ottawa Hospital.
A total of 24 people who have rapidly progressive MS will undergo bone marrow transplantation. A total of eight people with the same type of MS who decide not to participate in the study are serving as the control group.
Participants will be invited to join the study on the basis of the following criteria:
Participants must be able to travel to and stay in one of the treatment centre areas (Toronto, Ottawa or Montreal) for periods of time during the treatment procedure and be able to return periodically for monitoring. Repeated trips to Montreal for specialized MRI scanning will also be required for non-Montreal residents. The study coordinators will assist with these arrangements.
Bone Marrow Transplantation Procedure
The researchers are using what is known as autologous stem cell transplantation. They "harvest" a portion of each person's own stem cells which will then be used to create a "new" immune system once they are transplanted back into the person. Powerful chemotherapy drugs will be used to totally kill the immune cells that are attacking the protective myelin coating of the central nervous system as well as removing any source of their replenishment.
The following will take place, once a person meets the study criteria and agrees to take part in the study:
Risks and Side Effects
The many potential risks and complications will be explained to each participant at several meetings before they have to decide about participating in the study. Great caution is being taken to ensure the health and safety of each treated participant, but each step of this treatment carries a risk of serious complications. These may be severe enough in a small percentage of patients to be fatal. A safety committee of experts in the field of bone marrow transplantation and MS will monitor all decisions about patient treatment for their protection. Participants in the study will be actively monitored for six years including medical examinations and periodic MRI scans.
Some of the common side effects of the treatment include back pain, muscle aches, fatigue, nausea, vomiting, diarrhea, dry mouth and temporary hair loss. More severe side effects may be serious infections and, rarely, a late life malignancy.
Information about the Study
For more information about the bone marrow transplantation study, please contact the principal study coordinator: Marjorie Bowman, MS Research Clinic, The Ottawa Hospital, Phone: 613 737-8104; Fax: 613 739-6631
MS Scientific Research Foundation
The MS Scientific Research Foundation is related to the Multiple Sclerosis Society of Canada and receives more than 95% of its funding from the MS Society. While both organizations fund research, the MS Society also has an extensive services program for people with MS and their families. For more information, contact 1 800 268-7582 or www.mssociety.ca
The Multiple Sclerosis Society of Canada is an independent, voluntary health agency and does not approve, endorse or recommend any specific product or therapy but provides information to assist individuals in making their own decisions.
Multiple Sclerosis Society of Canada
250 Bloor Street East, Suite 1000
Toronto, Ontario M4W 3P9
Telephone: (416) 922-6065
Facsimile: (416) 922-7538
© 2002 Multiple Sclerosis Society of Canada