Evidence map›Paper›PMID 30092840›Full record

Trial reportStem cell research & therapy2018

Cell therapy induced regeneration of severely atrophied mandibular bone in a clinical trial.

Cecilie Gjerde, Kamal Mustafa, Sølve Hellem, Markus Rojewski, Harald Gjengedal, Mohammed Ahmed Yassin, Xin Feng, Siren Skaale, Trond Berge, Annika Rosen and 5 more

2 registry-linked trialsAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Stem cell research & therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 110 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
110citing papers in PubMed, 7 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.

NCT02751125 phase1completednot on this map

Jaw Bone Reconstruction Using a Combination of Autologous Mesenchymal Stem Cells and Biomaterial Prior to Dental Implant Placement

TypeinterventionalSponsorUniversity of BergenRan2014 to 2020Enrolled13ConditionsBone AtrophyArmsBCP with autologous mesenchymal stem cells (MSC).
NCT04297813 phase3completednot on this mapstarted 2020, after this paper: background citation

Randomized Controlled Clinical Trial to Assess the Efficacy of a Combination of Autologous Mesenchymal Stem Cells and Biomaterial in Jaw Bone Regeneration Prior to Dental Implant Placement in Comparison to Standard Autologous Bone Grafting

TypeinterventionalSponsorUniversity of BergenRan2020 to 2024Enrolled48ConditionsAlveolar Bone AtrophyArmsAdvanced medicinal Therapy (MSC combined with biomaterial), Autologous bone graft
3 · Its place in the literature

Who cites it

110 citing papers in PubMed, 7 syntheses or guidelines pooled it.

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  14. Characterization ofJournal of functional biomaterials · 2026
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50 more citing papers are in PubMed but not listed here.

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

15 authors.

Cecilie GjerdeInstitute of Clinical Dentistry, University of Bergen, Bergen, Norway. cecilie.gjerde@uib.no.ORCID 0000-0002-7581-6413
Kamal MustafaInstitute of Clinical Dentistry, University of Bergen, Bergen, Norway. kamal.mustafa@uib.no.
Sølve HellemInstitute of Clinical Dentistry, University of Bergen, Bergen, Norway.
Markus RojewskiInstitute of Transfusion Medicine, Ulm University, Ulm, Germany.
Harald GjengedalInstitute of Clinical Dentistry, University of Bergen, Bergen, Norway.
Mohammed Ahmed YassinInstitute of Clinical Dentistry, University of Bergen, Bergen, Norway.
Xin FengInstitute of Clinical Dentistry, University of Bergen, Bergen, Norway.
Siren SkaaleInstitute of Clinical Dentistry, University of Bergen, Bergen, Norway.
Trond BergeInstitute of Clinical Dentistry, University of Bergen, Bergen, Norway.
Annika RosenInstitute of Clinical Dentistry, University of Bergen, Bergen, Norway.
Xie-Qi ShiInstitute of Clinical Dentistry, University of Bergen, Bergen, Norway.
Aymen B AhmedDepartment of Internal Medicine, Hematology Section, Haukeland University Hospital, Bergen, Norway.
Bjørn Tore GjertsenDepartment of Internal Medicine, Hematology Section, Haukeland University Hospital, Bergen, Norway.
Hubert SchrezenmeierInstitute of Transfusion Medicine, Ulm University, Ulm, Germany.
Pierre LayrolleINSERM, UMR 1238, PHY-OS, Laboratory of Bone Sarcomas and Remodeling of Calcified Tissues, Faculty of Medicine, University of Nantes, Nantes, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAutologous grafting, despite some disadvantages, is still considered the gold standard for reconstruction of maxillofacial bone defects. The aim of this study was to evaluate bone regeneration using bone marrow-derived mesenchymal stromal cells (MSCs) in a clinical trial, a less invasive approach than autologous bone grafting. This comprehensive clinical trial included subjects with severe mandibular ridge resorption.

methodsThe study included 11 subjects aged 52-79 years with severe mandibular ridge resorption. Bone marrow cells were aspirated from the posterior iliac crest and plastic adherent cells were expanded in culture medium containing human platelet lysate. The MSCs and biphasic calcium phosphate granules as scaffolds were inserted subperiosteally onto the resorbed alveolar ridge. After 4-6 months of healing, new bone formation was assessed clinically and radiographically, as were safety and feasibility. Bone at the implant site was biopsied for micro-computed topography and histological analyses and dental implants were placed in the newly regenerated bone. Functional outcomes and patient satisfaction were assessed after 12 months.

resultsThe bone marrow cells, expanded in vitro and inserted into the defect together with biphasic calcium phosphate granules, induced significant new bone formation. The regenerated bone volume was adequate for dental implant installation. Healing was uneventful, without adverse events. The patients were satisfied with the esthetic and functional outcomes. No side effects were observed.

conclusionsThe results of this comprehensive clinical trial in human subjects confirm that MSCs can successfully induce significant formation of new bone, with no untoward sequelae. Hence, this novel augmentation procedure warrants further investigation and may form the basis of a valid treatment protocol, challenging the current gold standard.

trial registrationEudraCT, 2012-003139-50. Registered on 21 August 2013. ClinicalTrials.gov, NCT 02751125 . Registered on 26 April 2016.

Indexed as

Dental ImplantsAdolescentAdultAgedAged, 80 and overAlveolar Bone LossBone Marrow CellsBone RegenerationBone TransplantationCell- and Tissue-Based TherapyFemaleHumansHydroxyapatitesMaleMesenchymal Stem CellsMiddle AgedDental Implantshydroxyapatite-beta tricalcium phosphateHydroxyapatitesAlveolar ridge augmentationBiphasic calcium phosphateBone regenerationBone tissue engineeringDental implantsMesenchymal stem cells

Identifiers

PMID30092840
PMCPMC6085689

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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.