Evidence map›Paper›PMID 30230266›Full record

Trial reportJournal of cachexia, sarcopenia and muscle2018

Immunomodulatory placental-expanded, mesenchymal stromal cells improve muscle function following hip arthroplasty.

Tobias Winkler, Carsten Perka, Philipp von Roth, Alison N Agres, Henning Plage, Bernd Preininger, Matthias Pumberger, Sven Geissler, Esther Lukasiewicz Hagai, Racheli Ofir and 9 more

Abstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Journal of cachexia, sarcopenia and muscle, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed
–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

37 citing papers in PubMed.

  1. Trial
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  5. Article
  6. Review
  7. Review
  8. Advanced therapies in orthopaedics.EFORT open reviews · 2024
    Review
  9. Review
  10. Review
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Review
  19. Basic and Preclinical Research for Personalized Medicine.Journal of personalized medicine · 2021
    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

19 authors.

Tobias WinklerCenter for Musculoskeletal Surgery and Julius Wolff Institute, Charité-Universitaetsmedizin Berlin, Berlin, Germany.
Carsten PerkaCenter for Musculoskeletal Surgery and Julius Wolff Institute, Charité-Universitaetsmedizin Berlin, Berlin, Germany.
Philipp von RothCenter for Musculoskeletal Surgery and Julius Wolff Institute, Charité-Universitaetsmedizin Berlin, Berlin, Germany.
Alison N AgresCenter for Musculoskeletal Surgery and Julius Wolff Institute, Charité-Universitaetsmedizin Berlin, Berlin, Germany.
Henning PlageCenter for Musculoskeletal Surgery and Julius Wolff Institute, Charité-Universitaetsmedizin Berlin, Berlin, Germany.
Bernd PreiningerCenter for Musculoskeletal Surgery and Julius Wolff Institute, Charité-Universitaetsmedizin Berlin, Berlin, Germany.
Matthias PumbergerCenter for Musculoskeletal Surgery and Julius Wolff Institute, Charité-Universitaetsmedizin Berlin, Berlin, Germany.
Sven GeisslerCenter for Musculoskeletal Surgery and Julius Wolff Institute, Charité-Universitaetsmedizin Berlin, Berlin, Germany.ORCID 0000-0002-8750-6324
Esther Lukasiewicz HagaiPluristem Ltd, Haifa, Israel.
Racheli OfirPluristem Ltd, Haifa, Israel.
Lena PinzurPluristem Ltd, Haifa, Israel.
Eli EyalPluristem Ltd, Haifa, Israel.
Gisela Stoltenburg-DidingerInstitute of Cell Biology and Neurobiology, Charité-Universitaetsmedizin Berlin, Berlin, Germany.
Christian MeiselInstitute for Medical Immunology, Charité-Universitaetsmedizin Berlin, Berlin, Germany.
Christine ConsentiusBerlin-Brandenburg Center for Regenerative Therapies, Charité-Universitaetsmedizin Berlin, Berlin, Germany.
Mathias StreitzBerlin-Brandenburg Center for Regenerative Therapies, Charité-Universitaetsmedizin Berlin, Berlin, Germany.
Petra ReinkeBerlin-Brandenburg Center for Regenerative Therapies, Charité-Universitaetsmedizin Berlin, Berlin, Germany.
Georg N DudaCenter for Musculoskeletal Surgery and Julius Wolff Institute, Charité-Universitaetsmedizin Berlin, Berlin, Germany.
Hans-Dieter VolkBerlin-Brandenburg Center for Regenerative Therapies, Charité-Universitaetsmedizin Berlin, Berlin, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNo regenerative approach has thus far been shown to be effective in skeletal muscle injuries, despite their high frequency and associated functional deficits. We sought to address surgical trauma-related muscle injuries using local intraoperative application of allogeneic placenta-derived, mesenchymal-like adherent cells (PLX-PAD), using hip arthroplasty as a standardized injury model, because of the high regenerative and immunomodulatory potency of this cell type.

methodsOur pilot phase I/IIa study was prospective, randomized, double blind, and placebo-controlled. Twenty patients undergoing hip arthroplasty via a direct lateral approach received an injection of 3.0 × 10

resultsWe did not observe any relevant PLX-PAD-related adverse events at the 2-year follow-up. Improved gluteus medius strength was noted as early as Week 6 in the treatment-groups. Surprisingly, until Week 26, the low-dose group outperformed the high-dose group and reached significantly improved strength compared with placebo [150 M vs. placebo: P = 0.007 (baseline adjusted; 95% confidence interval 7.6, 43.9); preoperative baseline values mean ± SE: placebo: 24.4 ± 6.7 Nm, 150 M: 27.3 ± 5.6 Nm], mirrored by an increase in muscle volume [150 M vs. placebo: P = 0.004 (baseline adjusted; 95% confidence interval 6.0, 30.0); preoperative baseline values GM volume: placebo: 211.9 ± 15.3 cm

conclusionsAllogeneic PLX-PAD therapy improved strength and volume of injured skeletal muscle with a reasonable safety profile. Outcomes could be positively correlated with the modulation of early postoperative stress-related immunological reactions.

Indexed as

Arthroplasty, Replacement, HipImmunomodulationAgedBiomarkersBiomechanical PhenomenaFemaleHumansImmunityMagnetic Resonance ImagingMaleMesenchymal Stem CellsMiddle AgedMuscle, SkeletalPlacentaPregnancyRegenerationBiomarkersBiomarkersCell therapyImmunomodulationMesenchymal stromal cellsMuscle injuryMuscle regeneration

Identifiers

PMID30230266
PMCPMC6204595

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Registered trials

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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.