Transplantation of Bone Marrow Mesenchymal Stromal Cells for Periodontal Regeneration (BMMSC)

Instituto Venezolano de Investigaciones Cientificas

Status and phase: Invitation-only; Phase 2; Phase 1

Conditions: Aggressive Periodontitis; Chronic Periodontal Disease

Treatments: Biological: Transplantation of allogeneic MSCs in periodontal disease

Study type: Interventional

Funder types: Other

Identifiers

NCT05975892

IVIC-UTC-MSC-Periodontal

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Medical healthy
• Minimum age of 18 years old
• Diagnosis of chronic or aggressive periodontitis
• Vertical intrabony defects of three or two walls
• PPD >= 5 mm
• Radiographic evidence of alveolar bone loss of at least 3 mm
• Minimim 20 teeth presents in mouth.
• Informed consent of the patient

Exclusion criteria

• Smoking
• Pregnancy or lactating
• Receiving immunosuppressive drugs, anticoagulants, antibiotics or analgesic drugs
• Diabetics

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Allogeneic MSCs transplantation in periodontal disease

Experimental group

Description:

Allogeneic MSC harvested and cultured in osteogenic medium are seeded on collagen scaffold, mixed with autologous platelet rich plasma clot. The MSCs construct (MSCs/Coll/PRP clot) is implanted in the bone defect.

Treatment:

Biological: Transplantation of allogeneic MSCs in periodontal disease