Trial | NCT05975892  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Enrolling by invitation

  • Study Participants

    30
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 Started
Aug 30
2018
Primary Completion
Aug 30
2022
Study Completion
Aug 30
2024
Anticipated
Last Update
Aug 04
2023

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

Allogeneic MSCs transplantation in periodontal disease Experimental

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.

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
No Results Posted