Transplantation of Bone Marrow Mesenchymal Stromal Cells for Periodontal Regeneration

Instituto Venezolano de Investigaciones Cientificas30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Periodontal Disease Aggressive Periodontitis

Interventions

Transplantation of allogeneic MSCs in periodontal diseaseBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Instituto Venezolano de Investigaciones Cientificas

Caracas, Miranda, Venezuela

Outcomes

Primary Outcomes

Change in clinical attachment level (CAL)

Expressed as the distance in millimeters from the cemento-enamel junction (CEJ) to the bottom of the probable gingival/periodontal pocket.