Date: 2015-10-14
Type of information: Publication of results in a medical journal
phase: 2
Announcement: publication of results in Trials
Company: NHS (UK) Bristol Royal Hospital for Children (UK) University of Bristol (UK) University of Nottingham (UK) NHS Blood and Transplant (UK)
Product: bone marrow-derived cellular therapy
Action
mechanism: cell therapy
Disease: progressive multiple sclerosis
Therapeutic area: Neurodegenerative diseases
Country: UK
Trial
details: The ACTiMuS (Assessment of Bone Marrow-derived Cellular Therapy in Progressive Multiple Sclerosis) trial is a prospective, randomised, double-blind, placebo-controlled study. Eighty patients with progressive multiple sclerosis will be recruited; 60 will have secondary progressive disease (SPMS) but a subset (n?=?20) will have primary progressive disease (PPMS). Participants will be randomised to either early or late (1 year) intravenous infusion of autologous, unfractionated bone marrow. The placebo intervention is infusion of autologous blood. The primary outcome measure is global evoked potential derived from multimodal evoked potentials. Secondary outcome measures include adverse event reporting, clinical (EDSS and MSFC) and self-assessment (MSIS-29) rating scales, optical coherence tomography (OCT) as well as brain and spine MRI. Participants will be followed up for a further year following the final intervention. Outcomes will be analysed on an intention-to-treat basis.(NCT01815632 )
Latest
news: * On October 14, 2015, investigators of the ACTiMuS (Assessment of Bone Marrow-derived Cellular Therapy in Progressive Multiple Sclerosis) trial have published an assessment of the study protocol for this randomised controlled trial in Trials. The trial is the first randomised, placebo-controlled trial of non-myeloablative autologous bone marrow-derived stem cell therapy in multiple sclerosis. The study will examine the efficacy of intravenous delivery of autologous marrow in progressive multiple sclerosis. Laboratory studies performed in parallel with the clinical trial will further investigate the biology of bone marrow-derived stem cell infusion in multiple sclerosis, including mechanisms underlying repair. Recruitment to the ACTiMuS trial commenced in March 2014 and the trial is scheduled to be completed in October 2018. A phase I safety and feasibility study of intravenous autologous bone marrow infusion in patients with progressive multiple sclerosis has been completed. This study confirmed safety and raised the possibility of partial repair.
