MedTrace Logo

Transplantation of Bone Marrow Mesenchymal Stromal Cells for Periodontal Regeneration

NCT05975892 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-08-04

No results posted yet for this study

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.

Conditions

  • Chronic Periodontal Disease
  • Aggressive Periodontitis

Interventions

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

Sponsors & Collaborators

  • Universidad Central de Venezuela

    collaborator OTHER

  • Hospital Central Dr. Plácido D. Rodriguez Rivero, San Felipe, Yaracuy

    collaborator UNKNOWN

  • Instituto Venezolano de Investigaciones Cientificas

    lead OTHER

Principal Investigators

  • Jose E Cardier Montalvo, MD, PhD · Instituto Venezolano de Investigaciones Cientificas

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-30
Primary Completion
2022-08-30
Completion
2024-08-30

Countries

  • Venezuela

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05975892 on ClinicalTrials.gov