Bone Marrow Transplant Study Update Participant Death Appears Related to Transplant Complications

Medical Update Memo
May 15, 2003

The Multiple Sclerosis Society of Canada has been informed that a death has occurred in the bone marrow transplant study, which appears to be related to one of the drugs used in the transplant procedure. The Multiple Sclerosis Society of Canada regrets this death. While the study participant and his family were aware of the potential risk of having this experimental treatment, this outcome is sadly felt by all involved.

The transplant group is very closely reviewing the details surrounding the death and will report to the safety committee for the study. The committee will carefully evaluate the procedures being used and determine if any changes should be made. No additional participants will be transplanted until after the safety committee has met, but potential candidates will continue to be screened.

Background

• 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 are to 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.

• Seven participants have been treated to date with six coming through the procedure safely. Bone marrow transplantation is used frequently to treat leukemia. Because of the invasive nature of the treatment, there is a statistical possibility of a 5 to 8% mortality rate.

• Six of the seven transplant recipients had no serious complications as a result of the treatment. In initial follow up, the indications are that their disease has stabilized. They are being monitored closely with MRI scanning and immunological testing.

• 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.

The Multiple Sclerosis Society of Canada will continue to provide details about the bone marrow transplant study as soon as they are available.

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Disclaimer
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.