Safety and Feasibility of Autologous Bone Marrow Cellular Therapy in Relapsing-Progressive Multiple Sclerosis

In this phase I study, we assessed the safety and feasibility of intravenous, autologous bone marrow (BM) cell therapy, without immunosuppressive preconditioning, in six patients with clinically definite, relapsing‐progressive multiple sclerosis (MS). Assessment of efficacy was a secondary objective...

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Bibliographic Details
Published in:Clinical pharmacology and therapeutics 2010-06, Vol.87 (6), p.679-685
Main Authors: Rice, C M, Mallam, E A, Whone, A L, Walsh, P, Brooks, D J, Kane, N, Butler, S R, Marks, D I, Scolding, N J
Format: Article
Language:English
Subjects:
Adult
Bone Marrow Transplantation - adverse effects
Bone Marrow Transplantation - methods
Disability Evaluation
Evoked Potentials
Feasibility Studies
Female
Follow-Up Studies
Humans
Magnetic Resonance Imaging - methods
Male
Middle Aged
Multiple Sclerosis, Relapsing-Remitting - surgery
Prospective Studies
Transplantation, Autologous
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Summary:In this phase I study, we assessed the safety and feasibility of intravenous, autologous bone marrow (BM) cell therapy, without immunosuppressive preconditioning, in six patients with clinically definite, relapsing‐progressive multiple sclerosis (MS). Assessment of efficacy was a secondary objective and employed clinical disability rating scales, multimodal evoked potential (MMEP) recordings, and magnetic resonance imaging (MRI) scans. Cells were harvested, filtered and infused intravenously in a day‐case procedure that was well tolerated by patients and was not associated with any serious adverse events (AEs). Over a period of 12 months after the therapy, clinical disability scores showed either no change (Extended Disability Status Score, EDSS) or improvement (MS impact scale‐29, MSIS‐29), and MMEPs showed neurophysiological improvement. MRI scans did not show any significant changes over a post‐therapy period of 3 months. The lack of serious adverse effects and the suggestion of a beneficial effect in this small sample of patients with progressive disease justify conducting a larger phase II/III study to make a fuller assessment of the efficacy of mobilization of autologous BM in patients with MS. Clinical Pharmacology & Therapeutics (2010) 87 6, 679–685. doi: 10.1038/clpt.2010.44
ISSN:0009-9236
1532-6535
DOI:10.1038/clpt.2010.44