Treatment of Nonunion Fractures With Mesenchymal Stromal Cells (MSCs)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-30

Study Completion Date

2024-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pseudoarthrosis of Bone Pseudarthrosis Non Union Fracture Nonunion Bone Fracture

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Transplantation of autologous MSCs in nonunion fracture

Intervention Type BIOLOGICAL

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.)

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.

Group Type EXPERIMENTAL

Transplantation of allogeneic MSCs in nonunion fracture

Intervention Type BIOLOGICAL

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.)

Interventions

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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.)

Intervention Type 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.)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

10 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No