Clinical Trial

Study of Mesenchymal Autologous Stem Cells as Regenerative Treatment for Multiple Sclerosis

Study acronym: SMART-MS
Active, Not Recruiting Phase 1/2
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Summary
The primary objective of the study is to investigate neuroregenerative efficacy (proof of concept) of intrathecal treatment with autologous MSCs as measured by neurophysiological parameters in patients with progressive MS. Secondary objectives are to assess neuroregenerative efficacy as measured by other neurophysiological parameters as well as clinical, opthalmological and MRI modalities, and to assess safety of the treatment procedure.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2021-02-08; most recent amendment 2026-03-10.
Status change: Recruiting → Active, Not Recruiting 2023-09-08
Status change: Not Yet Recruiting → Recruiting 2021-09-07
Trial Details
NCT Number NCT04749667
Lead Sponsor Haukeland University Hospital
Collaborators: University of Bergen, University Hospital Ulm, University Hospital, Akershus, University Hospital of North Norway, St. Olavs Hospital
Conditions Multiple Sclerosis, Progressive Multiple Sclerosis
Enrollment 18 participants
Start Date 2021-08-09
Primary Completion 2025-03-24 (estimated)
Study Completion 2027-03-15 (estimated)
Updated on ClinicalTrials.gov 2026-03-12