Date: 2015-09-14
Type of information: Publication of results in a medical journal
phase: 1
Announcement: publication of results in The British Medical Journal
Company: North Bristol NHS Trust (UK)
Product: autologous bone marrow cells
Action
mechanism: cell therapy
Disease: multiple sclerosis
Therapeutic area: Neurodegenerative diseases
Country: UK
Trial
details: The ‘Study of Intravenous Autologous Marrow in Multiple Sclerosis (SIAMMS)’ trial is a safety and feasibility study which examined the effect of intravenous infusion of autologous bone marrow without myeloablative therapy.
This open, prospective, single-centre phase I extension study has invited the six patients with progressive multiple sclerosis who participated in the ‘SIAMMS’ study to undergo repeat bone marrow harvest and to receive an intravenous infusion of autologous, unfractionated bone marrow as a day-case procedure. The primary outcome measure is the number of adverse events, and secondary outcome measures will include change in clinical rating scales of disability, GEP and cranial MRI.( NCT01932593)
Latest
news: * On September 14, 2015, investigators of the SIAMMS-II trial have published results of the phase I extension study (SIAMMS-II) in The British Medical Journal (BMJ). The trial was well tolerated and improvement was noted in the global evoked potential (GEP)—a neurophysiological secondary outcome measure recording speed of conduction in central nervous system pathways. The efficacy of intravenous delivery of autologous marrow in progressive multiple sclerosis will be examined in the phase II study the ‘Assessment of Bone Marrow-Derived Cellular Therapy in Progressive Multiple Sclerosis (ACTiMuS ). The ‘Study of Intravenous Autologous Marrow in Multiple Sclerosis’ (SIAMMS) was a safety and feasibility study of intravenous autologous bone marrow infusion in patients with progressive multiple sclerosis. This study was well tolerated and also raised the possibility of partial repair; conduction times in multiple central nervous system (CNS) pathways collated as a composite score (global evoked potential, GEP) improved in all patients studied (n=6). The purpose of ‘SIAMMS-II’ is to explore whether the improvements observed in the initial study performed over 5?years ago have persisted and whether these can be repeated or augmented. The study is limited to the six people who participated in the original ‘SIAMMS’ study, all of whom are under active follow-up at the Bristol and Avon Multiple Sclerosis (BrAMS) Unit, North Bristol NHS Trust, Bristol, UK. ‘SIAMMS-II’ opened to recruitment in March 2014 and is ongoing.
