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Transplantation of Bone Marrow Mesenchymal Stromal Cells for Periodontal Regeneration (BMMSC)

Primary Purpose

Chronic Periodontal Disease, Aggressive Periodontitis

Status
Enrolling by invitation
Phase
Phase 1
Locations
Venezuela
Study Type
Interventional
Intervention
Transplantation of allogeneic MSCs in periodontal disease
Sponsored by
Instituto Venezolano de Investigaciones Cientificas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontal Disease focused on measuring Mesenchymal stromal cells, Periodontal regeneration, Bone regeneration, Periodontitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Instituto Venezolano de Investigaciones Cientificas

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Allogeneic MSCs transplantation in periodontal disease

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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
Change in bone density
Changes in the density of the periodontal bone defect will be detected by Cone beam Tomography
Change in Tooth Mobility (TM)
Changes from baseline in tooth mobility will be recorded.
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.

Secondary Outcome Measures

Full Information

First Posted
July 14, 2023
Last Updated
July 27, 2023
Sponsor
Instituto Venezolano de Investigaciones Cientificas
Collaborators
Universidad Central de Venezuela, Hospital Central Dr. Plácido D. Rodriguez Rivero, San Felipe, Yaracuy
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1. Study Identification

Unique Protocol Identification Number
NCT05975892
Brief Title
Transplantation of Bone Marrow Mesenchymal Stromal Cells for Periodontal Regeneration
Acronym
BMMSC
Official Title
Transplantation of Bone Marrow Mesenchymal Stromal Cells for Bone Regeneration in Periodontal Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 30, 2018 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Venezolano de Investigaciones Cientificas
Collaborators
Universidad Central de Venezuela, Hospital Central Dr. Plácido D. Rodriguez Rivero, San Felipe, Yaracuy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontal Disease, Aggressive Periodontitis
Keywords
Mesenchymal stromal cells, Periodontal regeneration, Bone regeneration, Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Allogeneic MSCs transplantation in periodontal disease
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Transplantation of allogeneic MSCs in periodontal disease
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in clinical attachment level (CAL)
Description
Expressed as the distance in millimeters from the cemento-enamel junction (CEJ) to the bottom of the probable gingival/periodontal pocket.
Time Frame
Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation
Title
Change in probing pocket depth (PPD)
Description
The distance from the gingival margin to the bottom of the gingival sulcus/pocket, is measured by means of periodontal probe.
Time Frame
Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation
Title
Gingival recession (GR)
Description
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
Time Frame
Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation
Title
Change in bone density
Description
Changes in the density of the periodontal bone defect will be detected by Cone beam Tomography
Time Frame
Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation
Title
Change in Tooth Mobility (TM)
Description
Changes from baseline in tooth mobility will be recorded.
Time Frame
Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation
Title
Change in bone depth
Description
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.
Time Frame
Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose E Cardier Montalvo, MD, PhD
Organizational Affiliation
Instituto Venezolano de Investigaciones Cientificas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Venezolano de Investigaciones Cientificas
City
Caracas
State/Province
Miranda
ZIP/Postal Code
1204
Country
Venezuela

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29678307
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.
Results Reference
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PubMed Identifier
26980620
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.
Results Reference
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PubMed Identifier
32493042
Citation
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.
Results Reference
background
PubMed Identifier
35307516
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.
Results Reference
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Transplantation of Bone Marrow Mesenchymal Stromal Cells for Periodontal Regeneration

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