Evidence map›Paper›PMID 24023694›Full record

Trial reportPloS one2013

Use of autologous human mesenchymal stromal cell/fibrin clot constructs in upper limb non-unions: long-term assessment.

Stefano Giannotti, Luisa Trombi, Vanna Bottai, Marco Ghilardi, Delfo D'Alessandro, Serena Danti, Giacomo Dell'Osso, Giulio Guido, Mario Petrini

Erratum issuedOpen access · goldAbstract readClinical Trial
In one paragraph

Trial report in PloS one, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 43 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 2 pooled it
5.0field-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.

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

43 citing papers in PubMed, 2 syntheses or guidelines pooled it, 96 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. The sole use of stem cells in treating fracture nonunion: a scoping review.Archives of orthopaedic and trauma surgery · 2025
    Article
  6. Article
  7. Article
  8. Cellular therapies for bone repair: current insights.Journal of orthopaedics and traumatology : official journal of the Italian Society of Orthopaedics and Traumatology · 2024
    Review
  9. 3D Printed Piezoelectric BaTiOBioengineering (Basel, Switzerland) · 2024
    Article
  10. Review
  11. Review
  12. Article
  13. Review
  14. Review
  15. Article
  16. Article
  17. Bone Marrow Aspirate Matrix: A Convenient Ally in Regenerative Medicine.International journal of molecular sciences · 2021
    Review
  18. AnStem cells international · 2021
    Review
  19. Article
  20. Article
4 · The record

Corrections and comments

  • Erratum issued
5 · Who and what money

Authors and funding

9 authors at 1 institution in 1 country.

Stefano GiannottiDept. of Translational Research and New Technology in Medicine and Surgery, University of Pisa, Pisa, Italy.
Luisa Trombi
Vanna Bottai
Marco Ghilardi
Delfo D'Alessandro
Serena Danti
Giacomo Dell'Osso
Giulio Guido
Mario Petrini
University of Pisa · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTissue engineering appears to be an attractive alternative to the traditional approach in the treatment of fracture non-unions. Mesenchymal stromal cells (MSCs) are considered an appealing cell source for clinical intervention. However, ex vivo cell expansion and differentiation towards the osteogenic lineage, together with the design of a suitable scaffold have yet to be optimized. Major concerns exist about the safety of MSC-based therapies, including possible abnormal overgrowth and potential cancer evolution.

aimsWe examined the long-term efficacy and safety of ex vivo expanded bone marrow MSCs, embedded in autologous fibrin clots, for the healing of atrophic pseudarthrosis of the upper limb. Our research work relied on three main issues: use of an entirely autologous context (cells, serum for ex vivo cell culture, scaffold components), reduced ex vivo cell expansion, and short-term MSC osteoinduction before implantation. METHODS AND

findingsBone marrow MSCs isolated from 8 patients were expanded ex vivo until passage 1 and short-term osteo-differentiated in autologous-based culture conditions. Tissue-engineered constructs designed to embed MSCs in autologous fibrin clots were locally implanted with bone grafts, calibrating their number on the extension of bone damage. Radiographic healing was evaluated with short- and long-term follow-ups (range averages: 6.7 and 76.0 months, respectively). All patients recovered limb function, with no evidence of tissue overgrowth or tumor formation.

conclusionsOur study indicates that highly autologous treatment can be effective and safe in the long-term healing of bone non-unions. This tissue engineering approach resulted in successful clinical and functional outcomes for all patients.

Indexed as

Prostheses and ImplantsStem Cell TransplantationAdolescentAdultAgedCompassionate Use TrialsFemaleFibrinHumansMaleMesenchymal Stem CellsMiddle AgedPseudarthrosisTime FactorsTransplantation, AutologousYoung AdultFibrin

Identifiers

PMID24023694
PMCPMC3758315
OpenAlexW2015257945

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.