Treatment of Nonunion Fractures With Mesenchymal Stromal Cells (MSCs)

Phase 1

• Conditions: Nonunion Bone Fracture; Pseudarthrosis; Non Union Fracture; Pseudoarthrosis of Bone
• Interventions: Biological: Transplantation of autologous MSCs in nonunion fracture; Biological: Transplantation of allogeneic MSCs in nonunion fracture

• Registration Number: NCT06103396
• Lead Sponsor: Instituto Venezolano de Investigaciones Cientificas

Brief 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.

Study Timeline

• Study Start: 2018-01-30
• Primary Completion: 2022-01-30
• Status Verified: 2023-10
• Study First Submitted: 2023-10-23
• Study First Submitted QC: 2023-10-23
• Study First Posted: 2023-10-26
• Last Update Submitted: 2023-10-27
• Last Update Posted: 2023-10-31
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autologuos MSCs transplantation in nonunion defects	Transplantation of autologous MSCs in nonunion fracture	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.
Allogeneic MSCs transplantation in nonunion defects	Transplantation of allogeneic MSCs in nonunion fracture	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Instituto Venezolano de Investigaciones Cientificas; 🇻🇪 Caracas, Miranda, Venezuela