PMID- 20445531 OWN - NLM STAT- MEDLINE DCOM- 20100603 LR - 20100520 IS - 1532-6535 (Electronic) IS - 0009-9236 (Linking) VI - 87 IP - 6 DP - 2010 Jun TI - Safety and feasibility of autologous bone marrow cellular therapy in relapsing-progressive multiple sclerosis. PG - 679-85 LID - 10.1038/clpt.2010.44 [doi] AB - 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. FAU - Rice, C M AU - Rice CM AD - Institute of Clinical Neurosciences, University of Bristol, Frenchay Hospital, Bristol, UK. FAU - Mallam, E A AU - Mallam EA FAU - Whone, A L AU - Whone AL FAU - Walsh, P AU - Walsh P FAU - Brooks, D J AU - Brooks DJ FAU - Kane, N AU - Kane N FAU - Butler, S R AU - Butler SR FAU - Marks, D I AU - Marks DI FAU - Scolding, N J AU - Scolding NJ LA - eng PT - Clinical Trial, Phase I PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20100505 PL - United States TA - Clin Pharmacol Ther JT - Clinical pharmacology and therapeutics JID - 0372741 SB - IM MH - Adult MH - Bone Marrow Transplantation/adverse effects/*methods MH - Disability Evaluation MH - *Evoked Potentials MH - Feasibility Studies MH - Female MH - Follow-Up Studies MH - Humans MH - Magnetic Resonance Imaging/*methods MH - Male MH - Middle Aged MH - Multiple Sclerosis, Relapsing-Remitting/*surgery MH - Prospective Studies MH - Transplantation, Autologous EDAT- 2010/05/07 06:00 MHDA- 2010/06/04 06:00 CRDT- 2010/05/07 06:00 PHST- 2010/05/07 06:00 [entrez] PHST- 2010/05/07 06:00 [pubmed] PHST- 2010/06/04 06:00 [medline] AID - clpt201044 [pii] AID - 10.1038/clpt.2010.44 [doi] PST - ppublish SO - Clin Pharmacol Ther. 2010 Jun;87(6):679-85. doi: 10.1038/clpt.2010.44. Epub 2010 May 5.