Clinical trial NCT02449005: Autologous Alveolar Bone Marrow Mesenchymal Stem Cells for the Reconstruction of Infrabony Periodontal Defects
Official title: A Phase I/II Double-Blind Randomised Controlled Clinical Trial To Study The Safety and Efficacy Of A Novel Regenerative Treatment Of Infrabony Periodontal Defects Using Autologous Alveolar Bone-Marrow Mesenchymal Stem Cells (aBM-MSCs).
Conditions: Chronic Periodontitis
Summary: Systemically healthy periodontitis patients are recruited from new referrals to the Department of Periodontology and Biology of Implants, AUTh. After completion of non-surgical periodontal treatment those subjects who have at least one interdental osseous defect with probing pocket depth and clinical attachment level of ≥ 6mm and an intrabony component of ≥ 3mm with no endodontic or furcation involvement are randomly allocated into one of the three treatment groups. Group A receives regenerative treatment using autologous bone marrow mesenchymal stem cells free of animal derived reagents, produced in clean room facilities and seeded into collagen scaffolds enriched with fibrin glue; in Group B, a collagen fleece enriched with fibrin glue devoid of stem cells fills the osseous defect; Group C receives open flap debridement retaining the soft wall of the defect. Thereafter, subjects are followed for 12 months and are repeatedly assessed based on clinical, radiographic, immunological and microbiological parameters.
In a series of cases, tissue engineering in a similar manner to Group A will be applied to treat isolated periodontal interdental defects, in combination with the novel "closed surgical technique".
Interventions:
description: Xeno-free, clinical-grade, autologous alveolar bone marrow mesenchymal stem cells enriched with autologous fibrin glue and loaded into a commercially available collagen fleece.
name: BM-MSCs/fibrin glue/collagen fleece
type: Biological
description: The biocomplex of autologous fibrin glue and collagen fleece devoid of stem cells will fill the osseous defect
name: Fibrin glue/collagen fleece
other_name: Procedure/Surgery/Growth factors
type: Other
description: Group C will receive minimally invasive surgery employing papilla preservation techniques in addition to retaining the soft tissue wall of the pocket. There will be no use of grafting materials
name: Open flap debridement
type: Procedure
Study arms:
design_group_description: Group A (BM-MSCs/fibrin glue/collagen fleece) will receive regenerative treatment using autologous bone marrow mesenchymal stem cells free of animal derived reagents, produced in clean room facilities and seeded into collagen scaffolds enriched with autologous fibrin glue
design_group_title: Group A
design_group_type: Experimental
design_group_description: in Group B (Fibrin glue/collagen fleece), a collagen fleece enriched with autologous fibrin glue devoid of stem cells will fill the osseous defect
design_group_title: Group B
design_group_type: Experimental
design_group_description: Group C will receive open flap debridement retaining the soft tissue wall of the pocket
design_group_title: Group C
design_group_type: Active Comparator
Sponsor: Aristotle University of Thessaloniki
Collaborators: University of Glasgow
Drug name mappings:
name: Autologous Alveolar Bone-Marrow Derived Mesenchymal Stem Cells(Aristotle University Of Thessaloniki)
lang: EN