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

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ClinicalTrials.gov Identifier: NCT05975892
Recruitment Status : Enrolling by invitation
First Posted : August 4, 2023
Last Update Posted : August 4, 2023
Sponsor:
Collaborators:
Universidad Central de Venezuela
Hospital Central Dr. Plácido D. Rodriguez Rivero, San Felipe, Yaracuy
Information provided by (Responsible Party):
Dylana Diaz Solano, Instituto Venezolano de Investigaciones Cientificas

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 30, 2018
Actual Primary Completion Date : August 30, 2022
Estimated Study Completion Date : August 30, 2024

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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.

  6. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05975892


Locations
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Venezuela
Instituto Venezolano de Investigaciones Cientificas
Caracas, Miranda, Venezuela, 1204
Sponsors and Collaborators
Instituto Venezolano de Investigaciones Cientificas
Universidad Central de Venezuela
Hospital Central Dr. Plácido D. Rodriguez Rivero, San Felipe, Yaracuy
Investigators
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Principal Investigator: Jose E Cardier Montalvo, MD, PhD Instituto Venezolano de Investigaciones Cientificas
More Information
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Publications:

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Responsible Party: Dylana Diaz Solano, Clinical Investigator, Instituto Venezolano de Investigaciones Cientificas
ClinicalTrials.gov Identifier: NCT05975892    
Other Study ID Numbers: IVIC-UTC-MSC-Periodontal
First Posted: August 4, 2023    Key Record Dates
Last Update Posted: August 4, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dylana Diaz Solano, Instituto Venezolano de Investigaciones Cientificas:
Mesenchymal stromal cells
Periodontal regeneration
Bone regeneration
Periodontitis
Additional relevant MeSH terms:
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Periodontitis
Periodontal Diseases
Aggressive Periodontitis
Chronic Periodontitis
Mouth Diseases
 Stomatognathic Diseases
Chronic Disease
Disease Attributes
Pathologic Processes