Evidence map›Paper›PMID 26467901›Full record

Trial reportTrials2015

Assessment of bone marrow-derived Cellular Therapy in progressive Multiple Sclerosis (ACTiMuS): study protocol for a randomised controlled trial.

Claire M Rice, David I Marks, Yoav Ben-Shlomo, Nikos Evangelou, Paul S Morgan, Chris Metcalfe, Peter Walsh, Nick M Kane, Martin G Guttridge, Gail Miflin and 7 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01815632 (Assessment of Bone Marrow-derived Cellular Therapy in Progressive Multiple Sclerosis), which is not on this map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed
5.1field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01815632 phase2unknown statusnot on this map

Assessment of Bone Marrow-derived Cellular Therapy in Progressive Multiple Sclerosis (ACTiMuS)

TypeinterventionalSponsorNorth Bristol NHS TrustRan2014 to 2019Enrolled80ConditionsProgressive Multiple SclerosisArmsEarly infusion of autologous marrow, Late infusion of autologous marrow
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 39 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Review
  5. Review
  6. Review
  7. Article
  8. Article
  9. Review
  10. Review
  11. Review
  12. Evolution of clinical trials in multiple sclerosis.Therapeutic advances in neurological disorders · 2019
    Review
  13. Review
  14. Article
  15. Evolution of Visual Outcomes in Clinical Trials for Multiple Sclerosis Disease-Modifying Therapies.Journal of neuro-ophthalmology : the official journal of the North American Neuro-Ophthalmology Society · 2018
    Review
  16. Review
  17. Article
  18. Review
  19. Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 4 institutions in 1 country.

Claire M RiceSchool of Clinical Sciences, Southmead Hospital, University of Bristol, Bristol, BS10 5NB, UK. c.m.rice@bristol.ac.uk.
David I MarksAdult BMT Unit, Bristol Royal Hospital for Children, University Hospitals Bristol NHS Foundation Trust & University of Bristol, St Michael's Hill, Bristol, BS2 8BJ, UK. david.marks@uhbristol.nhs.uk.
Yoav Ben-ShlomoSchool of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. Y.Ben-Shlomo@bristol.ac.uk.
Nikos EvangelouQueen's Medical Centre, School of Medicine, University of Nottingham, Nottingham, NG7 2UH, UK. Nikos.Evangelou@nottingham.ac.uk.
Paul S MorganQueen's Medical Centre, School of Medicine, University of Nottingham, Nottingham, NG7 2UH, UK. Paul.Morgan@nottingham.ac.uk.
Chris MetcalfeSchool of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. Chris.Metcalfe@bristol.ac.uk.
Peter WalshBristol Institute of Clinical Neurosciences, Southmead Hospital, Bristol, BS10 5NB, UK. Peter.walsh@nbt.nhs.uk.
Nick M KaneBristol Institute of Clinical Neurosciences, Southmead Hospital, Bristol, BS10 5NB, UK. Nick.kane@nbt.nhs.uk.
Martin G GuttridgeNHS Blood and Transplant, North Bristol Park, Bristol, BS34 7QH, UK. martin.guttridge@nhsbt.nhs.uk.
Gail MiflinNHS Blood and Transplant, North Bristol Park, Bristol, BS34 7QH, UK. gail.miflin@nhsbt.nhs.uk.
Stuart BlackmoreNHS Blood and Transplant, North Bristol Park, Bristol, BS34 7QH, UK. stuart.blackmore@nhsbt.nhs.uk.
Pamela SarkarSchool of Clinical Sciences, Southmead Hospital, University of Bristol, Bristol, BS10 5NB, UK. pamela.sarkar@bristol.ac.uk.
Juliana RedondoSchool of Clinical Sciences, Southmead Hospital, University of Bristol, Bristol, BS10 5NB, UK. Juliana.redondo@bristol.ac.uk.
Denise OwenBristol Institute of Clinical Neurosciences, Southmead Hospital, Bristol, BS10 5NB, UK. Denise.owen@nbt.nhs.uk.
David A CottrellBristol Institute of Clinical Neurosciences, Southmead Hospital, Bristol, BS10 5NB, UK. David.cottrell@nbt.nhs.uk.
Alastair WilkinsSchool of Clinical Sciences, Southmead Hospital, University of Bristol, Bristol, BS10 5NB, UK. Alastair.wilkins@bristol.ac.uk.
Neil J ScoldingSchool of Clinical Sciences, Southmead Hospital, University of Bristol, Bristol, BS10 5NB, UK. n.j.scolding@bristol.ac.uk.
University of Bristol · GBSouthmead Hospital · GBNHS Blood and Transplant · GBUniversity of Nottingham · GB

Funding

Medical Research Council MR/K004166/1
6 · The paper itself

Abstract

backgroundWe have recently completed an evaluation of the safety and feasibility of intravenous delivery of autologous bone marrow in patients with progressive multiple sclerosis (MS). The possibility of repair was suggested by improvement in the neurophysiological secondary outcome measure seen in all participants. The current study will examine the efficacy of intravenous delivery of autologous marrow in progressive MS. Laboratory studies performed in parallel with the clinical trial will further investigate the biology of bone marrow-derived stem cell infusion in MS, including mechanisms underlying repair. METHODS/

designA prospective, randomised, double-blind, placebo-controlled, stepped wedge design will be employed at a single centre (Bristol, UK). Eighty patients with progressive MS 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. DISCUSSION: Assessment of bone marrow-derived Cellular Therapy in progressive Multiple Sclerosis (ACTiMuS) is the first randomised, placebo-controlled trial of non-myeloablative autologous bone marrow-derived stem cell therapy in MS. It will determine whether bone marrow cell therapy can, as was suggested by the phase I safety study, improve conduction in multiple central nervous system pathways affected in progressive MS. Furthermore, laboratory studies performed in parallel with the clinical trial will inform our understanding of the cellular pharmacodynamics of bone marrow infusion in MS patients and the mechanisms underlying cell therapy.

trial registrationISRCTN27232902 Registration date 11/09/2012. NCT01815632 Registration date 19/03/2013.

Indexed as

Bone Marrow TransplantationBrainClinical ProtocolsDouble-Blind MethodEnglandEvoked PotentialsHumansIntention to Treat AnalysisMagnetic Resonance ImagingMultiple Sclerosis, Chronic ProgressiveNeural ConductionNeurologic ExaminationProspective StudiesReaction TimeRecovery of FunctionResearch Design

Identifiers

PMID26467901
PMCPMC4606493
OpenAlexW1921847973

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.