Repeat infusion of autologous bone marrow cells in multiple sclerosis: protocol for a phase I extension study (SIAMMS-II)

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...

Descripción completa

Detalles Bibliográficos
Autores principales: Rice, Claire M, Marks, David I, Walsh, Peter, Kane, Nick M, Guttridge, Martin G, Redondo, Juliana, Sarkar, Pamela, Owen, Denise, Wilkins, Alastair, Scolding, Neil J
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4567673/
https://www.ncbi.nlm.nih.gov/pubmed/26363342
http://dx.doi.org/10.1136/bmjopen-2015-009090
_version_ 1782389836578029568
author Rice, Claire M
Marks, David I
Walsh, Peter
Kane, Nick M
Guttridge, Martin G
Redondo, Juliana
Sarkar, Pamela
Owen, Denise
Wilkins, Alastair
Scolding, Neil J
author_facet Rice, Claire M
Marks, David I
Walsh, Peter
Kane, Nick M
Guttridge, Martin G
Redondo, Juliana
Sarkar, Pamela
Owen, Denise
Wilkins, Alastair
Scolding, Neil J
author_sort Rice, Claire M
collection PubMed
description 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. TRIAL REGISTRATION NUMBER: NCT01932593.
format Online
Article
Text
id pubmed-4567673
institution National Center for Biotechnology Information
language English
publishDate 2015
publisher BMJ Publishing Group
record_format MEDLINE/PubMed
spelling pubmed-45676732015-09-17 Repeat infusion of autologous bone marrow cells in multiple sclerosis: protocol for a phase I extension study (SIAMMS-II) Rice, Claire M Marks, David I Walsh, Peter Kane, Nick M Guttridge, Martin G Redondo, Juliana Sarkar, Pamela Owen, Denise Wilkins, Alastair Scolding, Neil J BMJ Open Neurology 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. TRIAL REGISTRATION NUMBER: NCT01932593. BMJ Publishing Group 2015-09-14 /pmc/articles/PMC4567673/ /pubmed/26363342 http://dx.doi.org/10.1136/bmjopen-2015-009090 Text en Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/
spellingShingle Neurology
Rice, Claire M
Marks, David I
Walsh, Peter
Kane, Nick M
Guttridge, Martin G
Redondo, Juliana
Sarkar, Pamela
Owen, Denise
Wilkins, Alastair
Scolding, Neil J
Repeat infusion of autologous bone marrow cells in multiple sclerosis: protocol for a phase I extension study (SIAMMS-II)
title Repeat infusion of autologous bone marrow cells in multiple sclerosis: protocol for a phase I extension study (SIAMMS-II)
title_full Repeat infusion of autologous bone marrow cells in multiple sclerosis: protocol for a phase I extension study (SIAMMS-II)
title_fullStr Repeat infusion of autologous bone marrow cells in multiple sclerosis: protocol for a phase I extension study (SIAMMS-II)
title_full_unstemmed Repeat infusion of autologous bone marrow cells in multiple sclerosis: protocol for a phase I extension study (SIAMMS-II)
title_short Repeat infusion of autologous bone marrow cells in multiple sclerosis: protocol for a phase I extension study (SIAMMS-II)
title_sort repeat infusion of autologous bone marrow cells in multiple sclerosis: protocol for a phase i extension study (siamms-ii)
topic Neurology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4567673/
https://www.ncbi.nlm.nih.gov/pubmed/26363342
http://dx.doi.org/10.1136/bmjopen-2015-009090
work_keys_str_mv AT riceclairem repeatinfusionofautologousbonemarrowcellsinmultiplesclerosisprotocolforaphaseiextensionstudysiammsii
AT marksdavidi repeatinfusionofautologousbonemarrowcellsinmultiplesclerosisprotocolforaphaseiextensionstudysiammsii
AT walshpeter repeatinfusionofautologousbonemarrowcellsinmultiplesclerosisprotocolforaphaseiextensionstudysiammsii
AT kanenickm repeatinfusionofautologousbonemarrowcellsinmultiplesclerosisprotocolforaphaseiextensionstudysiammsii
AT guttridgemarting repeatinfusionofautologousbonemarrowcellsinmultiplesclerosisprotocolforaphaseiextensionstudysiammsii
AT redondojuliana repeatinfusionofautologousbonemarrowcellsinmultiplesclerosisprotocolforaphaseiextensionstudysiammsii
AT sarkarpamela repeatinfusionofautologousbonemarrowcellsinmultiplesclerosisprotocolforaphaseiextensionstudysiammsii
AT owendenise repeatinfusionofautologousbonemarrowcellsinmultiplesclerosisprotocolforaphaseiextensionstudysiammsii
AT wilkinsalastair repeatinfusionofautologousbonemarrowcellsinmultiplesclerosisprotocolforaphaseiextensionstudysiammsii
AT scoldingneilj repeatinfusionofautologousbonemarrowcellsinmultiplesclerosisprotocolforaphaseiextensionstudysiammsii