Trial testing of an experimental stem cell treatment has been started by a clinical, opposed to best available biologic therapies for acute forms of relapsing multiple sclerosis (MS). National Institute of Allergy and Infectious Diseases (NIAID) is sponsoring the trial. The trial will basically compare the cost-effectiveness, efficacy and safety of both the therapeutic approaches.
MS is a disease in which a person’s central nervous system is attacked by its own immune cells. In its experimental treatment four chemical agents are used. The patient’s own blood-forming stem cells are infused back into them. This process is called autologous hematopoietic stem cell transplantation (AHSCT).
NIAID Director said that AHSCT had the potential to terminate the chances of relapsing MS.
MS is estimated to affect over 2.3 million people globally. Symptoms may include speech and motor difficulties, fatigue and chronic pain. Its most common form is relapsing-remitting MS.
Over a dozen drugs have been approved by the Food and Drug Administration for relapsing- MS. Studies suggest that AHSCT could be an effective treatment, but its comparison has never been made with third-line drugs which have serious side effects, but so does AHSCT, including death. Investigators are trying to determine which one is the better treatment.
The trial is known as BEAT-MS (BEst Available Therapy versus autologous hematopoietic stem cell transplant for Multiple Sclerosis). NIAID-funded Immune Tolerance Network is conducting it; the Blood and Marrow Transplant Clinical Trials Network are collaborating with them. The trial is being led by Jeffrey A. Cohen, M.D., a professor of neurology at the Cleveland Clinic Lerner College of Medicine and the director of the Experimental Therapeutics Program in the Mellen Center for Multiple Sclerosis Treatment and Research at the Cleveland Clinic.
BEAT-MS is to enroll 156 people in the US and the UK. Participants will be randomly given either of the two treatments and will be followed for 6 years. The neurologists will not know the type of treatment.
Other than the cost-effectiveness, efficacy and productivity, the neurologists will measure the time periods between an individual’s assignment to a treatment and MS-relapse or demise from any cause. Whether either occurs in the first 3 years or not.