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

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

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

Indications