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Treatment of Nonunion Fractures With Mesenchymal Stromal Cells (MSCs)

NCT06103396 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-10-31

No results posted yet for this study

Summary

The goal of this study is to evaluate the bone regeneration capacity of BM-MSC (Bone marrow mesenchymal stromal cells), in patients with nonunion. BM-MSC cultured are seeded on a collagen scaffold, included into autologous platelet-rich plasma (PRP) clot, and implanted in the nonunion bone defect.

Conditions

  • Pseudoarthrosis of Bone
  • Pseudarthrosis
  • Non Union Fracture
  • Nonunion Bone Fracture

Interventions

BIOLOGICAL

Transplantation of autologous MSCs in nonunion fracture

At surgery, fibrotic tissue is removed from the nonunion sites. MSCs/Col/PRP clots are implanted in the site of nonunion. Patients received conventional orthopedic treatment as they needed (osteotomy, external and/or internal fixation systems, etc.)

BIOLOGICAL

Transplantation of allogeneic MSCs in nonunion fracture

At surgery, fibrotic tissue is removed from the nonunion sites. MSCs/Col/PRP clots are implanted in the site of nonunion. Patients received conventional orthopedic treatment as they needed (osteotomy, external and/or internal fixation systems, etc.)

Sponsors & Collaborators

  • Hospital Central Dr. Plácido D. Rodriguez Rivero

    collaborator UNKNOWN

  • Instituto Autónomo Hospital Universitario de la Universidad de Los Andes

    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
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-30
Primary Completion
2022-01-30
Completion
2024-12-30

Countries

  • Venezuela

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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 NCT06103396 on ClinicalTrials.gov