This is a multi-center prospective rater-masked (blinded) randomized controlled trial of 156 participants, comparing the treatment strategy of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) to the treatment strategy of Best Available Therapy (BAT) for treatment-resistant relapsing multiple sclerosis (MS). Participants will be randomized at a 1 to 1 (1:1) ratio.
All participants will be followed for 72 months after randomization (Day 0, Visit 0).
Age 18 to 55 years, inclusive, at the time of the screening Visit -2.
Diagnosis of MS according to the 2017 McDonald Criteria139.
EDSS ≤ 6.0 at the time of randomization (Day 0).
T2 abnormalities on brain MRI that fulfill the 2017 McDonald MRI criteria for dissemination in space139. A detailed MRI report or MRI images must be available for review by the site neurology investigator.
Diagnosis of primary progressive MS according to the 2017 McDonald criteria.
History of neuromyelitis optica spectrum disorder or MOG antibody disease.
Prior treatment with an investigational agent within 3 months or 5 half-lives, whichever is longer. Agents authorized by the FDA for prevention or treatment of COVID-19 are not considered investigational.
Onset of acute MS relapse, or
National Institute of Allergy and Infectious Diseases (NIAID)
Lead sponsor
Immune Tolerance Network (ITN)
Collaborator
Blood and Marrow Transplant Clinical Trials Network
Collaborator
PPD Development, LP
Collaborator
Rho Federal Systems Division, Inc.
Collaborator