Tuesday, 15 September 2015

More Stem cell trials on the way

Rice CM, Marks DI, Walsh P, Kane NM, Guttridge MG, Redondo J, Sarkar P, Owen D, Wilkins A, Scolding NJ.Repeat infusion of autologous bone marrow cells in multiple sclerosis: protocol for a phase I extension study (SIAMMS-II).BMJ Open. 2015 Sep 11;5(9):e009090. doi: 10.1136/bmjopen-2015-009090.

INTRODUCTION: The 'Study of Intravenous Autologous Marrow in Multiple Sclerosis (SIAMMS)' trial was a safety and feasibility study which examined the effect of intravenous infusion of autologous bone marrow without myeloablative therapy. This 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 (MS) will be examined in the phase II study the 'Assessment of Bone Marrow-Derived Cellular Therapy in Progressive Multiple Sclerosis (ACTiMuS; NCT01815632)'. In parallel with the 'ACTiMuS' study, the current study 'SIAMMS-II' will explore the feasibility of repeated, non-myeloablative autologous bone marrow-derived cell therapy in progressive MS. Furthermore, information will be obtained regarding the persistence or otherwise of improvements in conduction in central nervous system pathways observed in the original 'SIAMMS' study and whether these can be reproduced or augmented by a second infusion of autologous bone marrow-derived cells.
METHODS AND ANALYSIS:An open, prospective, single-centre phase I extension study. The six patients with progressive MS who participated in the 'SIAMMS' study will be invited to undergo repeat bone marrow harvest and 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.
ETHICS AND DISSEMINATION:The study has UK National Research Ethics Committee approval (13/SW/0255). Study results will be disseminated via peer-reviewed publications and conference presentations.


Do they work that is the question. Because if we run before we can walk then it does no one any good.  The question is what is the mechanism of action of bone marrow supplementation in progressive MS, when immune therapy has been a universal dud.
I am sure it will be informative and let's hope it works.

2 comments:

  1. How do they harvest the cells? Could this result be the side effect of cyclophosphamide?

    ReplyDelete

Please note that all comments are moderated and any personal or marketing-related submissions will not be shown.