Clinical trial

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

ID

Name

IVIC-UTC-MSC-Periodontal

Description

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.

Trial arms

Trial start

2018-08-30

Estimated PCD

2022-08-30

Trial end

2024-08-30

Phase

Early phase I

Treatment

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

Arms:

Allogeneic MSCs transplantation in periodontal disease

Size

30

Primary endpoint

Change in clinical attachment level (CAL)

Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation

Change in probing pocket depth (PPD)

Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation

Gingival recession (GR)

Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation

Change in bone density

Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation

Change in Tooth Mobility (TM)

Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation

Change in bone depth

Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

Updated at

2023-08-04

1 organization

1 product

2 indications

Organization

Instituto Venezolano de Investigaciones Cientificas

Product

Transplantation of allogeneic MSCs

Indication

Chronic Periodontitis

Indication

Aggressive Periodontitis