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

July 27, 2023 updated by: Dylana Diaz Solano, Instituto Venezolano de Investigaciones Cientificas

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Venezuela
    • Miranda
      • Caracas, Miranda, Venezuela, 1204
        • Instituto Venezolano de Investigaciones Cientificas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in clinical attachment level (CAL)
Time Frame: 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.
Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation
Change in probing pocket depth (PPD)
Time Frame: 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.
Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation
Gingival recession (GR)
Time Frame: 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
Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation
Change in bone density
Time Frame: 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
Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation
Change in Tooth Mobility (TM)
Time Frame: Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation
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
Time Frame: 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.
Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Venezolano de Investigaciones Cientificas

Collaborators

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

Investigators

  • Principal Investigator: Jose E Cardier Montalvo, MD, PhD, Instituto Venezolano de Investigaciones Cientificas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2018

Primary Completion (Actual)

August 30, 2022

Study Completion (Estimated)

August 30, 2024

Study Registration Dates

First Submitted

July 14, 2023

First Submitted That Met QC Criteria

July 27, 2023

First Posted (Actual)

August 4, 2023

Study Record Updates

Last Update Posted (Actual)

August 4, 2023

Last Update Submitted That Met QC Criteria

July 27, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IVIC-UTC-MSC-Periodontal

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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