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Safety and Feasibility of Autologous Bone Marrow Cellular Therapy in Relapsing‐Progressive Multiple Sclerosis
Author(s) -
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
Publication year - 2010
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2010.44
Subject(s) - medicine , multiple sclerosis , adverse effect , expanded disability status scale , magnetic resonance imaging , bone marrow , oncology , surgery , radiology , immunology
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