NCT06103396

Treatment of Nonunion Fractures With Mesenchymal Stromal Cells (MSCs)

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Instituto Venezolano de Investigaciones Cientificas · Academic / Other
• Sex: All
• Age: 10 Years – 85 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
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.)

Timeline

• Start date: 2018-01-30
• Primary completion: 2022-01-30
• Completion: 2024-12-30
• First posted: 2023-10-26
• Last updated: 2023-10-31

Locations

1 site across 1 country: Venezuela