Autologous Hematopoietic Stem Cell Transplantation in Adults with MS
A phase 3 study involving 156 adults with relapsing MS is ongoing, comparing autologous hematopoietic stem cell transplantation to the best available therapy. The primary endpoint is MS relapse-free survival, with follow-up extending up to 72 months. However, no results from this study have been posted thus far.
- Tags
- #MSResearch
- Most relevant to
- —
- Source
- Read original source
- Human efficacy
- Not established from this source
- Mechanism
- Not reported
- Evidence strength
- No results yet
- Outcome
- Ongoing – no results yet
Why it matters
This research is significant for evaluating novel treatments for relapsing forms of MS, potentially improving patient outcomes. As the study is in progress, the implications for treatment are currently unknown.
What this does not prove
The study does not provide any results, limiting the ability to assess its effectiveness or safety at this time.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Interventional
- Participants / samples
- 156 · estimated
- Randomised
- Yes
- Controlled
- Yes
- Primary endpoint met
- Not reported
- Relevant MS type
- RRMS, SPMS
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Not reported
- Research areas
- Not classified
- Biological target
- Not reported
- Pathway
- Not reported
- Population
- Adults aged 18 to 55 years, with relapsing multiple sclerosis
- Size of effect
- Not reported
- Secondary endpoints
- Not reported
- MRI endpoints
- Not reported
- Biomarkers
- Not reported
- Safety
- Not reported
Original sources
Supporting passages (18)
study phasePhase: Phase 3
study designStudy type: Interventional
subjectsParticipants: people; ages from 18 Years to 55 Years; sex All
speciesParticipants: people; ages from 18 Years to 55 Years; sex All
sample sizeEnrollment: 156 participants (estimated)
sample size basisEnrollment: 156 participants (estimated)
randomizedAllocation: Randomized
controlledArm types: Experimental; Active comparator
peer reviewedTrial registry record.
interventionInterventions: Autologous Hematopoietic Stem Cell Transplantation; Best Available Therapy (BAT)
comparatorInterventions: Autologous Hematopoietic Stem Cell Transplantation; Best Available Therapy (BAT)
primary endpointPrimary endpoints: Multiple Sclerosis (MS) Relapse-Free Survival
follow upFollow-up: From Day 0 (Randomization to Treatment) Up to 36 Months (3 Years); From Day 0 (Randomization to Treatment) Up to 72 Months (6 Years); Day 0 (Randomization to Treatment) Up to Month 72 (6 Years); From Visit Pre-R Up to 72 Months (6 Years); From Day of Graft Infusion (Receipt of Peripheral Blood Stem Cells-PBSC Infusion) Up to 72 Months (6 Years); From Day of Transplant (Receipt of Peripheral Blood Stem Cells-PBSC Infusion) Up to Day 28 Post Transplant
limitationsNo results are posted.
populationAge 18 to 55 years, inclusive, at the time of the screening Visit -2.\n2.
outcome"status": "RECRUITING",
findingsTrial registry record. Publication date: unknown. No results are posted. Planned enrolment and endpoints are not findings.
relevant ms typesConditions: Relapsing Multiple Sclerosis; Relapsing Remitting Multiple Sclerosis; Secondary Progressive Multiple Sclerosis
AI assessment, not yet reviewed by a person · version 3 · Community votes are separate from evidence review.