May 26, 2009
MS Trial Alert: Sites in Ohio, Texas, and Washington Recruiting for a Small Study of Autologous ("Self") Hematopoietic Stem Cell Transplant Underway
Summary: Investigators at three sites in the United States (Columbus, Ohio; Houston, Texas; and Seattle, Washington) are conducting an open-label study to test the safety and effectiveness of high-dose immunosuppressive therapy (chemotherapy) followed by autologous (cells from patient’s own blood) hematopoietic stem cell transplant in 30 people with relapsing-remitting* or progressive-relapsing* MS. The investigators will consider participants who are not patients in their treatment centers, but please keep in mind that several visits and a hospital stay are necessary for this trial (travel expenses will be reimbursed). This study also is known as the HALT-MS study, and is funded by the National Institute of Allergy and Infectious Disease of the National Institutes of Health.
Rationale: Autologous hematopoietic stem cell transplantation uses the patients’ own blood or bone marrow stem cells. The procedure generally involves first collecting a person’s cells that are capable of regenerating into new immune cells. These “stem cells” are stored, and then the rest of his or her immune cells are destroyed by a chemotherapy regimen. After chemotherapy, the stored stem cells are reintroduced by injection. Eventually they grow and repopulate the body with new immune cells. The hope is that the new immune cells will no longer attack nerve fiber-insulating myelin or other brain tissue (the targets of the immune attack in MS), having learned to be “immune tolerant.” This attempt to “reboot” the immune system is strictly investigational for MS, although it has obtained FDA approval for other diseases, such as cancer. The procedure is not without risk, one of these being serious, potentially life-threatening infections due to the weakened state of the immune system before it is fully restored. Adjunct medications such as antibiotics and antivirals are being provided in this study to reduce this risk.
Eligibility and Details: Participants must be between the ages of 18 and 60, and diagnosed with relapsing-remitting or progressive-relapsing MS less than 15 years ago. They will have active disease, despite previous treatment with disease-modifying therapies.
At the beginning of the study, participants will undergo a number of screening and baseline procedures, including a physical exam, blood collection, neurology exams and questionnaires, and MRI scans. After transplantation, participants will remain in the hospital for observation and will be monitored for infections. Following discharge from the hospital, eight study visits will occur over five years.
Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please contact the site nearest you or visit http://www.halt-ms.org/index.html.
*Relapsing-Remitting MS - People with this type of MS experience clearly defined attacks of worsening neurologic function followed by partial or complete recovery periods.
**Progressive-Relapsing MS - In this relatively rare course of MS, people experience steadily worsening disease from the beginning, but with clear attacks of worsening neurologic function along the way.