Treatment of Nonunion Fractures With Mesenchymal Stromal Cells (MSCs) (MSC)

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

Treatment of Nonunion After Fractures (Pseudoartrosis) Using Mesenchymal Stromal Cells (MSCs)

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Nonunion (pseudoarthrosis) is one of the most serious complications of bone fracture. Even though different treatments have been used to repair nonunion bone defects, most of them have limitations, like morbidities, limited supply, frequent treatment failure, and high cost.

Based on the knowledge that MSC have multipotential capacity of differentiation into bone, cartilage, fat, and endothelial cells, and also, play a key role in the process of bone formation and fracture repair. In this study, we evaluated the use the bone regeneration capacity of autologous or allogeneic BM-MSC, as a potential therapeutic strategy to induce formation of new bone tissue and fracture healing.

A bioengineering construct, constituted by MSCs and a collagen scaffold, is incorporated into platelet rich plasma (PRP) clot, wich is implanted at the nonunion site defect.

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Post-traumatic nonunion diagnosis (Pseudoarthrosis) with or without previous ortopaedic treatment
  • Patients with or without previous orthopaedic treatment
  • Presence of nonunion 9 month or more
  • Ossification failure in the non-union area, with an approximate size of 0.5 to 4 cm length

Exclusion Criteria:

  • Evidence of infection at the nonunion site (Osteomielitis)
  • Evidence of cutaneous lesion at the site of pseudoartrosis
  • Viral hepatitis B and C, HIV infection, syphilis and other viral and bacterial infections
  • Autoimmune diseases
  • Neoplastic diseases
  • Pregnancy
  • Major metabolic disorders
  • Treatment with steroids
  • Other conditions or circumstances that compromise the study participation according to medical criteria

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Autologuos MSCs transplantation in nonunion defects
Autologuos MSCs harvested and cultured in osteogenic medium are seeded on collagen scaffold, and mixed with autologous rich plasma clot. The MSCs construct (MSCs/Col/PRP clot), is implanted in the nonunion defect.
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.)
Experimental: Allogeneic MSCs transplantation in nonunion defects
Allogeneic MSCs harvested and cultured in osteogenic medium are seeded on collagen scaffold, and mixed with autologous rich plasma clot. The MSCs construct (MSCs/Col/PRP clot), is implanted in the nonunion defect.
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.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical evaluation
Time Frame: Baseline, 1 and 7 days. 1, 2 and 6 months. 1 and 2 years
Time of surgical wound evolution, surgically intervened limb evolution, movility
Baseline, 1 and 7 days. 1, 2 and 6 months. 1 and 2 years
Bone consolidation
Time Frame: Baseline, 1 and 7 days. 1, 2 and 6 months. 1 and 2 years
Time of development changes in bone consolidation by radiological studies
Baseline, 1 and 7 days. 1, 2 and 6 months. 1 and 2 years

Collaborators and Investigators

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

Sponsor

Instituto Venezolano de Investigaciones Cientificas

Collaborators

Hospital Central Dr. Plácido D. Rodriguez Rivero
Instituto Autónomo Hospital Universitario de la Universidad de Los Andes

Investigators

  • Study Chair: 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)

January 30, 2018

Primary Completion (Actual)

January 30, 2022

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

October 23, 2023

First Submitted That Met QC Criteria

October 23, 2023

First Posted (Actual)

October 26, 2023

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 27, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IVIC-UTC-MSC-Pseudarthrosis

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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