Transplantation of Bone Marrow Mesenchymal Stromal Cells for Periodontal Regeneration

Aggressive Periodontitis Clinical Trial

— BMMSC  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05975892
• Other study ID #: IVIC-UTC-MSC-Periodontal
• Status: Enrolling by invitation
• Phase: Phase 1/Phase 2
• Start date: August 30, 2018
• Est. completion date: August 30, 2024

Study information

• Verified date: July 2023
• Source: Instituto Venezolano de Investigaciones Cientificas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Aggressive Periodontitis
• Chronic Periodontitis
• Periodontal Diseases
• Periodontitis

Intervention

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

Locations

Country	Name	City	State
Venezuela	Instituto Venezolano de Investigaciones Cientificas	Caracas	Miranda

Sponsors (3)

Lead Sponsor	Collaborator
Instituto Venezolano de Investigaciones Cientificas	Hospital Central Dr. Plácido D. Rodriguez Rivero, San Felipe, Yaracuy, Universidad Central de Venezuela

Country where clinical trial is conducted

Venezuela, 

References & Publications (4)

Gomez M, Wittig O, Diaz-Solano D, Cardier JE. Mesenchymal Stromal Cell Transplantation Induces Regeneration of Large and Full-Thickness Cartilage Defect of the Temporomandibular Joint. Cartilage. 2021 Dec;13(1_suppl):1814S-1821S. doi: 10.1177/1947603520926711. Epub 2020 Jun 4. — View Citation

Gomez-Sosa JF, Diaz-Solano D, Wittig O, Cardier JE. Dental Pulp Regeneration Induced by Allogenic Mesenchymal Stromal Cell Transplantation in a Mature Tooth: A Case Report. J Endod. 2022 Jun;48(6):736-740. doi: 10.1016/j.joen.2022.03.002. Epub 2022 Mar 18. — View Citation

Wittig O, Diaz-Solano D, Cardier J. Viability and functionality of mesenchymal stromal cells loaded on collagen microspheres and incorporated into plasma clots for orthopaedic application: Effect of storage conditions. Injury. 2018 Jun;49(6):1052-1057. doi: 10.1016/j.injury.2018.04.005. Epub 2018 Apr 5. — View Citation

Wittig O, Romano E, Gonzalez C, Diaz-Solano D, Marquez ME, Tovar P, Aoun R, Cardier JE. A method of treatment for nonunion after fractures using mesenchymal stromal cells loaded on collagen microspheres and incorporated into platelet-rich plasma clots. Int Orthop. 2016 May;40(5):1033-8. doi: 10.1007/s00264-016-3130-6. Epub 2016 Mar 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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