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Assessment of bone marrow-derived Cellular Therapy in progressive Multiple Sclerosis (ACTiMuS): study protocol for a
Claire M Rice1,2, David I Marks3, Yoav Ben-Shlomo4
1School of Clinical Sciences, Southmead Hospital, University of Bristol, Bristol, BS10 5NB, UK. c.m.rice@bristol.ac.uk.
Trials
|October 16, 2015
Summary
This study investigates autologous bone marrow stem cell therapy for progressive multiple sclerosis (MS). It aims to determine if this treatment improves neurological function and understand the underlying biological mechanisms for potential repair.
Area of Science:
- Neuroscience
- Regenerative Medicine
- Immunology
Background:
- Previous studies suggested safety and feasibility of autologous bone marrow infusion for progressive multiple sclerosis (MS).
- Neurophysiological improvements were observed, indicating potential for repair in MS patients.
- This research builds upon prior safety evaluations to assess therapeutic efficacy.
Purpose of the Study:
- To evaluate the efficacy of intravenous autologous bone marrow infusion in progressive MS patients.
- To investigate the biological mechanisms of bone marrow-derived stem cell therapy in MS.
- To determine if the treatment can improve conduction in affected central nervous system pathways.
Main Methods:
- A prospective, randomized, double-blind, placebo-controlled, stepped wedge trial involving 80 progressive MS patients (60 SPMS, 20 PPMS).
- Participants received early or late (1-year) intravenous infusion of autologous bone marrow or autologous blood (placebo).
- Primary outcome: global evoked potential; Secondary outcomes: adverse events, clinical scales (EDSS, MSFC), self-assessment (MSIS-29), OCT, and MRI.
Main Results:
- The study is designed to analyze outcomes on an intention-to-treat basis, comparing treatment and placebo groups.
- Neurophysiological improvements observed in a prior safety study suggest potential efficacy.
- The trial will provide data on the primary outcome of global evoked potential and various secondary measures.
Conclusions:
- The ACTiMuS trial is the first randomized, placebo-controlled study of non-myeloablative autologous bone marrow-derived stem cell therapy for MS.
- It will assess the potential of bone marrow cell therapy to enhance conduction in the central nervous system of progressive MS patients.
- Parallel laboratory studies will elucidate the cellular pharmacodynamics and repair mechanisms of bone marrow infusion in MS.
