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There are currently only a few approved treatments for MS [what is MS?] that are designed to modify the course of the disease: interferon (Avonex®, Betaseron®, Rebif®), glatiramer acetate (Copaxone®) and mitoxantrone (Novantrone®) are likely familiar to most MS sufferers. These drugs are taken on a long-term basis, with the goal of slowing the natural course of MS. For those MS sufferers who have more active or advanced disease, there are even fewer effective treatment options.
The HALT-MS study is investigating an experimental treatment of intensive immunosuppression to determine whether it can stabilize the disease in patients with relapsing-remitting or progressive relapsing MS and a poor prognosis.
HALT-MS is a clinical trial in which we are studying the use of high-dose immunosuppression (chemotherapy) followed by autologous hematopoietic (blood) stem cell transplantation as a treatment for poor-prognosis MS.
Before high-dose immunosuppression, blood stem cells (those cells that go on to produce all blood cells) are collected or withdrawn from the participant’s own bloodstream. The collected cells are processed in a lab to select the blood stem cells and remove the T cells that are thought to cause autoimmune diseases like MS). The selected blood stem cells are then frozen or stored. The participant then undergoes intensive immunosuppression with high-dose chemotherapy. The selected blood stem cells are returned to the patient as an infusion to restore the blood counts after the treatment. We are investigating if the immune system will be “reset” after the intensive immunosuppression preventing further relapses or loss of neurological function.
Briefly, the study consists of the following phases:
Screening: Evaluations will be done to determine if a participant is eligible for the study. Tests will include a neurological evaluation, blood work, MRI, lumbar puncture, and an assessment of the lungs (pulmonary function test and chest x-ray) and the heart (ECG and echocardiogram or MUGA scan) .
A pilot study in Europe has tested this technique in 19 MS patients. Eighteen (18) of those treated had their disease stabilize or improve for at least three years following treatment; One patient showed a new lesion on magnetic resonance imaging (MRI) of the brain 4.5 years after treatment.
The HALT-MS study aims to extend the results of that study, to establish the safety and effectiveness of the treatment for advanced MS and to learn more about how the treatment works on the immune system.
Like all medicines, there are risks of side effects and complications involved in receiving an experimental therapy in a clinical trial. Some of these risks are known and others may be unknown. For instance, it is not uncommon to experience flu-like symptoms (nausea, vomiting, fever, fatigue, muscle and joint aches, headaches) related to the medications used in this study and there is a risk of experiencing allergic reactions to these medications. Complications specific to MS can occur after high-dose immunosuppressive therapy and there is a risk of infection. Every attempt is made to minimize each patient's risk of side effects, and each individual's experience will vary in both the type and number of side effects, as well as their severity. If you are interested in participating in HALT-MS, our study staff will explain the potential risks and benefits of the treatment in detail and will be happy to answer any additional questions you might have about the trial.