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Stem Cell Res Ther. 2018 Aug 9;9(1):213. doi: 10.1186/s13287-018-0951-9.

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

Author information

1
Institute of Clinical Dentistry, University of Bergen, Bergen, Norway. cecilie.gjerde@uib.no.
2
Institute of Clinical Dentistry, University of Bergen, Bergen, Norway. kamal.mustafa@uib.no.
3
Institute of Clinical Dentistry, University of Bergen, Bergen, Norway.
4
Institute of Transfusion Medicine, Ulm University, Ulm, Germany.
5
Institute for Clinical Transfusion Medicine and Immunogenetics Ulm, Red Cross Blood Service Baden-Württemberg-Hessen and Institute for Transfusion Medicine, University Hospital Ulm, Ulm, Germany.
6
Department of Fibre and Polymer Technology, KTH Royal Institute of Technology, 10044, Stockholm, Sweden.
7
Department of Internal Medicine, Hematology Section, Haukeland University Hospital, Bergen, Norway.
8
Centre for Cancer Biomakers CCBIO, Bergen, Norway.
9
Department of Clinical Science, Precision Oncology Research Group, University of Bergen, Bergen, Norway.
10
INSERM, UMR 1238, PHY-OS, Laboratory of Bone Sarcomas and Remodeling of Calcified Tissues, Faculty of Medicine, University of Nantes, Nantes, France.

Abstract

BACKGROUND:

Autologous 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.

METHODS:

The 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.

RESULTS:

The 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.

CONCLUSIONS:

The 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 REGISTRATION:

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

KEYWORDS:

Alveolar ridge augmentation; Biphasic calcium phosphate; Bone regeneration; Bone tissue engineering; Dental implants; Mesenchymal stem cells

PMID:
30092840
PMCID:
PMC6085689
DOI:
10.1186/s13287-018-0951-9
[Indexed for MEDLINE]
Free PMC Article

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