Treatment of Nonunion Fractures With Mesenchymal Stromal Cells (MSCs)

Instituto Venezolano de Investigaciones Cientificas

Status and phase: Invitation-only; Phase 2; Phase 1

Conditions: Non Union Fracture; Pseudarthrosis; Pseudoarthrosis of Bone; Nonunion Bone Fracture

Treatments: Biological: Transplantation of autologous MSCs in nonunion fracture; Biological: Transplantation of allogeneic MSCs in nonunion fracture

Study type: Interventional

Funder types: Other

Identifiers

NCT06103396

IVIC-UTC-MSC-Pseudarthrosis

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 10 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Autologuos MSCs transplantation in nonunion defects

Experimental group

Description:

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.

Treatment:

Biological: Transplantation of autologous MSCs in nonunion fracture

Allogeneic MSCs transplantation in nonunion defects

Experimental group

Description:

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.

Treatment:

Biological: Transplantation of allogeneic MSCs in nonunion fracture