NCT05975892

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2018

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 4, 2023

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

August 4, 2023

Status Verified

July 1, 2023

Enrollment Period

4 years

First QC Date

July 14, 2023

Last Update Submit

July 27, 2023

Conditions

Chronic Periodontal DiseaseAggressive Periodontitis

Keywords

Mesenchymal stromal cellsPeriodontal regenerationBone regenerationPeriodontitis

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

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.

Biological: Transplantation of allogeneic MSCs in periodontal disease

Interventions

Transplantation of allogeneic MSCs in periodontal diseaseBIOLOGICAL

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Smoking
  • Pregnancy or lactating
  • Receiving immunosuppressive drugs, anticoagulants, antibiotics or analgesic drugs
  • Diabetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Venezolano de Investigaciones Cientificas

Caracas, Miranda, 1204, Venezuela

Location

Related Publications (4)

  • 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.

    PMID: 29678307BACKGROUND

  • 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.

    PMID: 26980620BACKGROUND

  • 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.

    PMID: 32493042BACKGROUND

  • 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.

    PMID: 35307516BACKGROUND

MeSH Terms

Conditions

Chronic PeriodontitisAggressive PeriodontitisPeriodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jose E Cardier Montalvo, MD, PhD

    Instituto Venezolano de Investigaciones Cientificas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Investigator

Study Record Dates

First Submitted

July 14, 2023

First Posted

August 4, 2023

Study Start

August 30, 2018

Primary Completion

August 30, 2022

Study Completion

August 30, 2024

Last Updated

August 4, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

VE(1)