Evidence map›Paper›PMID 31070229›Full record

Trial reportRheumatology (Oxford, England)2019

Bone-marrow derived mesenchymal stromal cells infusion in therapy refractory juvenile idiopathic arthritis patients.

Joost F Swart, Sytze de Roock, Rutger A J Nievelstein, Ineke C M Slaper-Cortenbach, Jaap J Boelens, Nico M Wulffraat

Abstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Rheumatology (Oxford, England), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Review
  4. Review
  5. Review
  6. Review
  7. Article
  8. Review
  9. Article
  10. [Clinical characteristics and biological treatment of adult patient with juvenile idiopathic arthritis].Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences · 2020
    Article
  11. Immune Pathogenesis of COVID-19 Intoxication: Storm or Silence?Pharmaceuticals (Basel, Switzerland) · 2020
    Review
  12. Mesenchymal Stromal Cells and Exosomes: Progress and Challenges.Frontiers in cell and developmental biology · 2020
    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

6 authors.

Joost F SwartDepartment of Pediatric Immunology and Rheumatology, UMC Utrecht, Wilhelmina Children's Hospital.
Sytze de RoockDepartment of Pediatric Immunology and Rheumatology, UMC Utrecht, Wilhelmina Children's Hospital.
Rutger A J NievelsteinFaculty of Medicine, Utrecht University.
Ineke C M Slaper-CortenbachCell Therapy Facility, Division Laboratories and Pharmacy, UMC Utrecht, Utrecht, The Netherlands.
Jaap J BoelensDepartment of Pediatric Immunology and Rheumatology, UMC Utrecht, Wilhelmina Children's Hospital.
Nico M WulffraatDepartment of Pediatric Immunology and Rheumatology, UMC Utrecht, Wilhelmina Children's Hospital.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo compare the total number of adverse events (AEs) before and after mesenchymal stromal cell (MSC) infusion in refractory JIA and to evaluate its effectiveness.

methodsSingle-centre Proof of Mechanism Phase Ib, open label intervention study in JIA patients previously failing all biologicals registered for their diagnosis. Six patients received 2 million/kg intravenous infusions of allogeneic bone-marrow derived MSC. In case of ACR-Ped30-response but subsequent loss of response one and maximal two repeated infusions are allowed.

resultsSix JIA patients with 9.2 years median disease duration, still active arthritis and damage were included. All had failed methotrexate, corticosteroids and median five different biologicals. MSC were administered twice in three patients. No acute infusion reactions were observed and a lower post-treatment than pre-treatment incidence in AEs was found. The one systemic onset JIA (sJIA) patient had again an evolving macrophage activation syndrome, 9 weeks after tocilizumab discontinuation and 7 weeks post-MSC infusion. Statistically significant decreases were found 8 weeks after one MSC infusion in VAS well-being (75-56), the JADAS-71 (24.5-11.0) and the cJADAS10 (18.0-10.6).

conclusionMSC infusions in six refractory JIA patients were safe, although in sJIA stopping the 'failing' biologic treatment carries a risk of a MAS flare, as the drug might still suppress the systemic features.

trial registrationTrial register.nl, http://https://www.trialregister.nl, NTR4146.

Indexed as

Bone Marrow CellsMesenchymal Stem CellsAdolescentArthritis, JuvenileChildFemaleHumansInfusions, IntravenousMaleMesenchymal Stem Cell TransplantationPilot ProjectsProof of Concept StudyTreatment OutcomeJuvenile arthritismesenchymal stromal cellsstem cell transplantationtherapeutics

Identifiers

PMID31070229
PMCPMC6758577

What OpenQuestion holds

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Registered trials

None linked

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.