Evidence map›Paper›PMID 28744314›Full record

ArticleStem cells international2017

Changes of Bone Turnover Markers in Long Bone Nonunions Treated with a Regenerative Approach.

Donatella Granchi, Enrique Gómez-Barrena, Markus Rojewski, Philippe Rosset, Pierre Layrolle, Benedetta Spazzoli, Davide Maria Donati, Gabriela Ciapetti

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Stem cells international, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01842477 (Evaluation of Efficacy and Safety of Autologous MSCs Combined to Biomaterials to Enhance Bone Healing in Patients With Delayed Consolidation After Long Bone Fracture Requiring Graft Apposition or Alternative Orthobiologics), which is not on this 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
2.5field-weighted citation impact, top 13% 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.

NCT01842477 phase2completednot on this map

Evaluation of Efficacy and Safety of Autologous MSCs Combined to Biomaterials to Enhance Bone Healing in Patients With Delayed Consolidation After Long Bone Fracture Requiring Graft Apposition or Alternative Orthobiologics

TypeinterventionalSponsorInstitut National de la Santé Et de la Recherche Médicale, FranceRan2013 to 2016Enrolled30ConditionsDelayed Union After Fracture of Humerus, Tibial or FemurArmsImplantation of bone substitute plus autologous cultured mesenchymal cells
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Article
  3. Review
  4. Review
  5. Article
  6. Article
  7. Article
  8. Changes of Bone Turnover Markers and Bone Tissue Content After Severe Osteoporotic Vertebral Compression Fracture.Medical science monitor : international medical journal of experimental and clinical research · 2020
    Article
  9. Review
  10. Prognostic potential of markers of bone turnover in delayed-healing tibial diaphyseal fractures.European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2019
    Observational
  11. Review
  12. Bioceramics and bone healing.EFORT open reviews · 2018
    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

8 authors at 5 institutions in 4 countries.

Donatella GranchiOrthopedic Pathophysiology and Regenerative Medicine Unit, Rizzoli Orthopedic Institute, Bologna, Italy.
Enrique Gómez-BarrenaHospital La Paz, IdiPAZ, Universidad Autónoma de Madrid, Madrid, Spain.ORCID 0000-0003-1065-6137
Markus RojewskiInstitute for Clinical Transfusion Medicine and Immunogenetic Ulm (IKT Ulm), Ulm, Germany.
Philippe RossetService of Orthopaedic Surgery and Traumatology, CHRU, Tours, France.
Pierre LayrolleInserm U957, Laboratoire de Physiopathologie de la Résorption Osseuse et Thérapie des Tumeurs Osseuses Primitives (LPRO), University of Nantes, Nantes, France.
Benedetta SpazzoliIII Orthopedic and Traumatology Clinic, Rizzoli Orthopedic Institute, Bologna, Italy.
Davide Maria DonatiIII Orthopedic and Traumatology Clinic, Rizzoli Orthopedic Institute, Bologna, Italy.
Gabriela CiapettiOrthopedic Pathophysiology and Regenerative Medicine Unit, Rizzoli Orthopedic Institute, Bologna, Italy.ORCID 0000-0001-6740-0357
Istituto Ortopedico Rizzoli · ITCentre Hospitalier Universitaire de Tours · FRImmungenetics (Germany) · DEInserm · FRUniversidad Autónoma de Madrid · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In this clinical trial, we investigated if biochemical bone turnover markers (BTM) changed according to the progression of bone healing induced by autologous expanded MSC combined with a biphasic calcium phosphate in patients with delayed union or nonunion of long bone fractures. Bone formation markers, bone resorption markers, and osteoclast regulatory proteins were measured by enzymatic immunoassay before surgery and after 6, 12, and 24 weeks. A satisfactory bone healing was obtained in 23 out of 24 patients. Nine subjects reached a good consolidation already at 12 weeks, and they were considered as the "early consolidation" group. We found that bone-specific alkaline phosphatase (BAP), C-terminal propeptide of type I procollagen (PICP), and beta crosslaps collagen (CTX) changed after the regenerative treatment, BAP and CTX correlated to the imaging results collected at 12 and 24 weeks, and BAP variation along the healing course differed in patients who had an "early consolidation." A remarkable decrease in BAP and PICP was observed at all time points in a single patient who experienced a treatment failure, but the predictive value of BTM changes cannot be determined. Our findings suggest that BTM are promising tools for monitoring cell therapy efficacy in bone nonunions, but studies with larger patient numbers are required to confirm these preliminary results.

Identifiers

PMID28744314
PMCPMC5506673
OpenAlexW2692876275

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.