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

Study acronym: SMART-MS
StatusActive, Not Recruiting
PhasePhase 1/2
Started2021-08-09
View on ClinicalTrials.gov ↗

Amendment history

2026-03-10
Study Status, Sponsor/Collaborators v5
Primary completion dateestimated 2024-10-04→confirmed 2025-03-24
Completion date2025-01-04→2027-03-15
Collaborators5 entries, reordered
2023-09-08
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v4
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 4 of 4 sites
2022-07-28
Study Status, Contacts/Locations v3
Study sitesdetails revised at 3 of 4 sites
2022-03-18
Study Status v2
Re-verified, no change to tracked fields
2021-09-07
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-04-04→confirmed 2021-08-09
Study sitesdetails revised at 4 of 4 sites
2021-02-08
Original filing
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.
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