NCT02449005: PerioRegen

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).

Completed Phase 1/Phase 2 Last updated 1 June 2022

What this trial tests

Phase 1/Phase 2 trial testing BM-MSCs/fibrin glue/collagen fleece in Chronic Periodontitis in 30 participants. Completed in 1 December 2016.

Timeline

1 March 2014

Primary endpoint
1 September 2016

1 December 2016

Quick facts

Lead sponsor	Aristotle University Of Thessaloniki
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	30
Start date	1 March 2014
Primary completion	1 September 2016
Estimated completion	1 December 2016
Sites	1 location across Greece

Drugs / interventions tested

• BM-MSCs/fibrin glue/collagen fleece — full drug profile →
• Fibrin glue/collagen fleece
• Open flap debridement — full drug profile →

Conditions studied

• Chronic Periodontitis — all drugs for Chronic Periodontitis →

Sponsor

Aristotle University Of Thessaloniki

Who can join

Adults 20 to 65, any sex, with Chronic Periodontitis. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• A reduction in the distance in mm from the bottom of the periodontal pocket to the cementoenamel junction using a manual probe (Hu-Friedy XP-23/QW, Hu-Friedy, Chicago, IL, USA) with 20-25g of pressure by a single calibrated examiner.
  Time frame: up to 12- months
  Clinical data (gain in clinical attachment level (CAL))

Sponsor's own description

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".

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Stem cell-based bone and dental regeneration: a view of microenvironmental modulation.
   Zheng C, Chen J, Liu S, Jin Y. · · 2019 · cited 162× · PMID 31423011 · DOI 10.1038/s41368-019-0060-3
2. Mesenchymal Stromal Cell-Based Bone Regeneration Therapies: From Cell Transplantation and Tissue Engineering to Therapeutic Secretomes and Extracellular Vesicles.
   Marolt Presen D, Traweger A, Gimona M, Redl H. · · 2019 · cited 104× · PMID 31828066 · DOI 10.3389/fbioe.2019.00352
3. Therapeutic potential of periodontal ligament stem cells.
   Queiroz A, Albuquerque-Souza E, Gasparoni LM, de França BN, et al · · 2021 · cited 60× · PMID 34249230 · DOI 10.4252/wjsc.v13.i6.605
4. Application of Stem Cells in Oral Disease Therapy: Progresses and Perspectives.
   Yang B, Qiu Y, Zhou N, Ouyang H, et al · · 2017 · cited 32× · PMID 28421002 · DOI 10.3389/fphys.2017.00197
5. Immunomodulatory Properties of Stem Cells in Periodontitis: Current Status and Future Prospective.
   Wang M, Xie J, Wang C, Zhong D, et al · · 2020 · cited 29× · PMID 32724318 · DOI 10.1155/2020/9836518
6. Immunomodulatory Mechanism and Potential Application of Dental Pulp-Derived Stem Cells in Immune-Mediated Diseases.
   Min Q, Yang L, Tian H, Tang L, et al · · 2023 · cited 23× · PMID 37175774 · DOI 10.3390/ijms24098068
7. Mechanisms underlying dental-derived stem cell-mediated neurorestoration in neurodegenerative disorders.
   Raza SS, Wagner AP, Hussain YS, Khan MA. · · 2018 · cited 22× · PMID 30257724 · DOI 10.1186/s13287-018-1005-z
8. Bone Regeneration with Mesenchymal Stem Cells in Scaffolds: Systematic Review of Human Clinical Trials.
   Theodosaki AM, Tzemi M, Galanis N, Bakopoulou A, et al · · 2024 · cited 17× · PMID 38407793 · DOI 10.1007/s12015-024-10696-5