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

Pseudarthrosis Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06103396
Study type Interventional
Source Instituto Venezolano de Investigaciones Cientificas
Contact
Status Enrolling by invitation
Phase Phase 1/Phase 2
Start date January 30, 2018
Completion date December 30, 2024
View Details
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