Evidence map›Paper›PMID 30127049›Full record

Trial reportBMJ open2018

A randomised placebo-controlled double-blind trial to assess the safety of intramuscular administration of allogeneic mesenchymal stromal cells for digital ulcers in systemic sclerosis: the MANUS Trial protocol.

Femke C C van Rhijn-Brouwer, Hendrik Gremmels, Joost O Fledderus, Arnold H Schuurman, Femke Bonte-Mineur, Madelon C Vonk, Alexandre E Voskuyl, Jeska K de Vries-Bouwstra, J Henk Coert, Timothy R D J Radstake and 3 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03211793 (Mesenchymal Stromal Cells for Angiogenesis and Neovascularisation in Digital Ulcers of Systemic Sclerosis), which is not on this map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
2.5field-weighted citation impact, top 11% 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.

NCT03211793 phase1 / phase2recruitingnot on this mapstarted 2021, after this paper: background citation

Mesenchymal Stromal Cells for Angiogenesis and Neovascularisation in Digital Ulcers of Systemic Sclerosis: the MANUS Trial

TypeinterventionalSponsorUMC UtrechtRan2021 to 2026Enrolled20ConditionsSystemic Sclerosis, Digital UlcerArmsMesenchymal stromal cells, Placebo
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.

  1. Pooled it
  2. Stem cell therapy in systemic sclerosis.Clinical rheumatology · 2025
    Review
  3. Article
  4. Article
  5. Article
  6. Stem cell-based therapy for systemic sclerosis.Rheumatology advances in practice · 2023
    Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Review
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  13. Review
  14. Locoregional delivery of stem cell-based therapies.Science translational medicine · 2020
    Review
  15. Review
  16. Article
  17. Review
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

13 authors at 6 institutions in 1 country.

Femke C C van Rhijn-BrouwerDepartment of Nephrology and Hypertension, University Medical Center Utrecht, Utrecht, The Netherlands.
Hendrik GremmelsDepartment of Nephrology and Hypertension, University Medical Center Utrecht, Utrecht, The Netherlands.
Joost O FledderusDepartment of Nephrology and Hypertension, University Medical Center Utrecht, Utrecht, The Netherlands.
Arnold H SchuurmanDepartment of Plastic Reconstructive and Hand Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.
Femke Bonte-MineurDepartment of Rheumatology, Maasstad Ziekenhuis, Rotterdam, The Netherlands.
Madelon C VonkDepartment of Rheumatology, Radboud University Medical Center, Nijmegen, The Netherlands.
Alexandre E VoskuylAmsterdam Rheumatology and Immunology Center, VU University Medical Center (VUmc), Amsterdam, The Netherlands.
Jeska K de Vries-BouwstraDepartment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.
J Henk CoertDepartment of Plastic Reconstructive and Hand Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.
Timothy R D J RadstakeDepartment of Rheumatology and Clinical Immunology, University Medical Center Utrecht, Utrecht, The Netherlands.
Jacob M van LaarDepartment of Rheumatology and Clinical Immunology, University Medical Center Utrecht, Utrecht, The Netherlands.
Marianne C VerhaarDepartment of Nephrology and Hypertension, University Medical Center Utrecht, Utrecht, The Netherlands.
MANUS Study Group
University Medical Center Utrecht · NLAmsterdam UMC Location VUmc · NLLeiden University Medical Center · NLMaasstad Ziekenhuis · NLRadboud University Medical Center · NLUtrecht University · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSystemic sclerosis (SSc) is an autoimmune disease characterised by inflammation, fibrosis and vasculopathy. Digital ulcers (DUs) are a frequent manifestation of vasculopathy in patients with SSc. Despite recent advances in pharmacological treatments, DU still have major health and economic implications. As there is currently no proven therapeutic strategy to promote DU healing, new treatments are urgently needed. Mesenchymal stem or stromal cells (MSCs) may provide a novel therapy for DU in SSc, because of their immunomodulatory and vasculoregenerative properties. Allogeneic MSC therapy involves functionally competent MSCs from healthy donors and may be used as 'off-the-shelf' available treatment. This study will evaluate whether allogeneic MSC therapy is a safe and potentially efficacious treatment for DU of SSc. METHODS AND ANALYSIS: The MANUS ( ETHICS AND DISSEMINATION: The study has been approved by the Dutch Central Committee on Research Concerning Human Subjects (protocol no: NL51705.000.15). The results will be disseminated through patient associations and conventional scientific channels. TRIAL REGISTRATION NUMBER: NCT03211793; Pre-results.

Indexed as

Mesenchymal Stem Cell TransplantationAdultAllograftsClinical ProtocolsDouble-Blind MethodHumansInjections, IntramuscularScleroderma, SystemicSkin Ulcerangiogenesisdigital ulcersmesenchymal stromal cellssystemic sclerosis

Identifiers

PMID30127049
PMCPMC6104757
OpenAlexW2888319218

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.