Transplantation of Bone Marrow Mesenchymal Stromal Cells for Periodontal Regeneration

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Periodontal Disease, Aggressive Periodontitis

Intervention / Treatment
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* Biological: Transplantation of allogeneic MSCs in periodontal disease


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Allogeneic MSCs transplantation in periodontal disease<br>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. | Biological: Transplantation of allogeneic MSCs in periodontal disease<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation | 
| Change in probing pocket depth (PPD) | The distance from the gingival margin to the bottom of the gingival sulcus/pocket, is measured by means of periodontal probe. | Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation | 
| Gingival recession (GR) | Exposure of the tooth through apical migration of the gingiva will be recorded as the distance in millimeters from the CEJ to the gingival margin | Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation | 
| Change in bone density | Changes in the density of the periodontal bone defect will be detected by Cone beam Tomography | Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation | 
| Change in Tooth Mobility (TM) | Changes from baseline in tooth mobility will be recorded. | Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation | 
| Change in bone depth | The vertical bone defects will be assessed by X-rays. The postoperative depth of the intrabony defect will be calculated from the distance between the cemento-enamel junction and the bone crest on the preoperative and postoperative radiographs at the same magnification. | Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mesenchymal stromal cells, Periodontal regeneration, Bone regeneration, Periodontitis