BMMSC: Transplantation of Bone Marrow Mesenchymal Stromal Cells for Periodontal Regeneration

Sponsor

Instituto Venezolano de Investigaciones Cientificas (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05975892

Collaborator

Universidad Central de Venezuela (Other), Hospital Central Dr. Plácido D. Rodriguez Rivero, San Felipe, Yaracuy (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Periodontal Disease Aggressive Periodontitis	Biological: Transplantation of allogeneic MSCs in periodontal disease	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 30, 2018

Actual Primary Completion Date :

Aug 30, 2022

Anticipated Study Completion Date :

Aug 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Allogeneic MSCs transplantation in periodontal disease 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 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

Arm

Intervention/Treatment

Experimental: Allogeneic MSCs transplantation in periodontal disease

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

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

Outcome Measures

Primary Outcome Measures

Change in clinical attachment level (CAL) [Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation]
Expressed as the distance in millimeters from the cemento-enamel junction (CEJ) to the bottom of the probable gingival/periodontal pocket.
Change in probing pocket depth (PPD) [Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation]
The distance from the gingival margin to the bottom of the gingival sulcus/pocket, is measured by means of periodontal probe.
Gingival recession (GR) [Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation]
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
Change in bone density [Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation]
Changes in the density of the periodontal bone defect will be detected by Cone beam Tomography
Change in Tooth Mobility (TM) [Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation]
Changes from baseline in tooth mobility will be recorded.
Change in bone depth [Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation]
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.