Autologous Alveolar Bone Marrow Mesenchymal Stem Cells for the Reconstruction of Infrabony Periodontal Defects
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".
Timeline
- Start
- 2014-03
- Primary completion
- 2016-09
- Completion
- 2016-12
Publications
- Background Bakopoulou A, Leyhausen G, Volk J, Koidis P, Geurtsen W. Comparative characterization of STRO-1(neg)/CD146(pos) and STRO-1(pos)/CD146(pos) apical papilla stem cells enriched with flow cytometry. Arch Oral Biol. 2013 Oct;58(10):1556-68. doi: 10.1016/j.archoralbio.2013.06.018. Epub 2013 Jul 18.
- Background Bland JM, Altman DG. Measuring agreement in method comparison studies. Stat Methods Med Res. 1999 Jun;8(2):135-60. doi: 10.1177/096228029900800204.
- Background Cortellini P, Tonetti MS. Minimally invasive surgical technique and enamel matrix derivative in intra-bony defects. I: Clinical outcomes and morbidity. J Clin Periodontol. 2007 Dec;34(12):1082-8. doi: 10.1111/j.1600-051X.2007.01144.x. Epub 2007 Oct 22.
- Background Cortellini P. Minimally invasive surgical techniques in periodontal regeneration. J Evid Based Dent Pract. 2012 Sep;12(3 Suppl):89-100. doi: 10.1016/S1532-3382(12)70021-0.
- Background Dominici M, Le Blanc K, Mueller I, Slaper-Cortenbach I, Marini F, Krause D, Deans R, Keating A, Prockop Dj, Horwitz E. Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement. Cytotherapy. 2006;8(4):315-7. doi: 10.1080/14653240600855905.
- Background Altman DG. Statistics in the medical literature: 3. Stat Med. 1999 Feb 28;18(4):487-90. doi: 10.1002/(sici)1097-0258(19990228)18:43.0.co;2-j. No abstract available.
- Apatzidou DA, Iliopoulos JM, Konstantinidis A, Verma M, Hardy P, Lappin DF, Nile CJ. Inflammatory and bone remodelling related biomarkers following periodontal transplantation of the tissue engineered biocomplex. Clin Oral Investig. 2024 Jun 7;28(7):361. doi: 10.1007/s00784-024-05754-8.
- Apatzidou DA, Bakopoulou AA, Kouzi-Koliakou K, Karagiannis V, Konstantinidis A. A tissue-engineered biocomplex for periodontal reconstruction. A proof-of-principle randomized clinical study. J Clin Periodontol. 2021 Aug;48(8):1111-1125. doi: 10.1111/jcpe.13474. Epub 2021 May 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BM-MSCs | Cell therapy | — | — |