NCT05975892

Transplantation of Bone Marrow Mesenchymal Stromal Cells for Periodontal Regeneration

Transplantation of Bone Marrow Mesenchymal Stromal Cells for Bone Regeneration in Periodontal Disease

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Instituto Venezolano de Investigaciones Cientificas · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to evaluate the capacity of allogeneic bone marrow mesenchymal stromal cells (MSC) to induce bone regeneration in patients with periodontal disease. MSC cultured are loaded on a collagen scaffold, included into autologous platelet rich plasma clot and implanted in the bone defect.

Detailed description

The clinical protocol is designed to evaluate the bone regeneration capacity of allogeneic MSCs for the treatment of patients with chronic or aggressive periodontal disease. Patients with either a 2- or 3-wall intrabony defects are included in this study. A bioengineering construct, constituted by allogeneic MSCs and a collagen scaffold, is incorporated into platelet rich plasma (PRP) clot, which is implanted at the bone defect site. Follow up of treated tooth are assessed by clinical evaluation, intraoral radiography and cone-beam CT.

Conditions

• Chronic Periodontal Disease
• Aggressive Periodontitis

Interventions

Type	Name	Description
BIOLOGICAL	Transplantation of allogeneic MSCs in periodontal disease	Oral surgery is performed in patients with periodontal disease, under local anesthesia. An incision will be made on the periodontal lesion, A full-thickness flap is elevated on both the buccal and lingual areas and the inner epithelium of the flap removed. Granulation tissue is removed from bone defect area, and a root planning is performed. MSC construct is placed around the bone defect and a collagen membrane is used to cover and close off the bone defect site. The flap will be repositioned and the wound closed by a suture

Timeline

• Start date: 2018-08-30
• Primary completion: 2022-08-30
• Completion: 2024-08-30
• First posted: 2023-08-04
• Last updated: 2023-08-04

Locations

1 site across 1 country: Venezuela