Stem Cells in Rapidly Evolving Active Multiple Sclerosis

Summary

This is a randomised, double-blind crossover study to study the effect of intravenous treatment with autologous (derived from the individuals themselves) mesenchymal stem cells (MSCs) in patients with multiple sclerosis (MS).

Timeline

Start

2013-01

Primary completion

2019-08

Completion

2019-08

Outcome

Missed primary endpoint

registry analysis (other test); A: Mesenchymal Stem Cells First Then Placebo vs B: Placebo First, Then MSCs; p = 0.84; t-test, 2 sided NCT01606215 ↗

registry analysis (other test); A: Mesenchymal Stem Cells First Then Placebo vs B: Placebo First, Then MSCs; p = 0.62; t-test, 2 sided NCT01606215 ↗

registry analysis (other test); A: Mesenchymal Stem Cells First Then Placebo vs B: Placebo First, Then MSCs; p = 0.61; t-test, 2 sided NCT01606215 ↗

Publications

• Results Uccelli A, Laroni A, Brundin L, Clanet M, Fernandez O, Nabavi SM, Muraro PA, Oliveri RS, Radue EW, Sellner J, Soelberg Sorensen P, Sormani MP, Wuerfel JT, Battaglia MA, Freedman MS; MESEMS study group. MEsenchymal StEm cells for Multiple Sclerosis (MESEMS): a randomized, double blind, cross-over phase I/II clinical trial with autologous mesenchymal stem cells for the therapy of multiple sclerosis. Trials. 2019 May 9;20(1):263. doi: 10.1186/s13063-019-3346-z.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	mesenchymal stem cells	Cell therapy	1e+06 cells/kg	Intravenous
Subject	mesenchymal stem cells	Cell therapy	2e+06 cells/kg	Intravenous

Indications