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

Phase 1/2 Active not recruiting 18 enrolled Haukeland University Hospital St. Olavs Hospital · collab University Hospital Ulm · collab University Hospital of North Norway · collab University Hospital, Akershus · collab University of Bergen · collab

RandomizedCrossoverTriple-blindTreatment

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.

Timeline

Start: 2021-08-09
Primary completion: 2025-03-24
Completion: 2027-03-15

Outcome

Missed primary endpoint

paper No significant between-group difference was observed for the primary end point (β = -0.31, 95% CI -1.84 to 1.22, p = 0.668). PMID 42081777 ↗

Publications

Kvistad CE, Krakenes T, Holmoy T, Eidem LE, Steffensen L, Wesnes K, Rojewski M, Eichele T, Wergeland S, Gavasso S, Barsnes H, Assmus J, Al-Sharabi N, Mohamed-Ahmed S, Vrenken H, Brouwer I, Mutsaerts HM, Tranfa M, Gjerde C, Ytterdal M, Rodahl E, Berven FS, Schrezenmeier H, Mustafa K, Bo L. Intrathecal Mesenchymal Stem Cells in Progressive Multiple Sclerosis: A Randomized, Double-Blind, Placebo-Controlled Trial (SMART-MS). Neurology. 2026 May 26;106(10):e214915. doi: 10.1212/WNL.0000000000214915. Epub 2026 May 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	mesenchymal stem cells	Cell therapy	1 cells/kg	Intrathecal