Clinical trial

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

Name

IVIC-UTC-MSC-Pseudarthrosis

Description

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.

Trial arms

Trial start

2018-01-30

Estimated PCD

2022-01-30

Trial end

2024-12-30

Phase

Early phase I

Treatment

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.)

Arms:

Autologuos MSCs transplantation in nonunion defects

Transplantation of allogeneic MSCs in nonunion fracture

Arms:

Allogeneic MSCs transplantation in nonunion defects

Size

Primary endpoint

Clinical evaluation

Baseline, 1 and 7 days. 1, 2 and 6 months. 1 and 2 years

Bone consolidation

Baseline, 1 and 7 days. 1, 2 and 6 months. 1 and 2 years

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

Updated at

2023-10-31

1 organization

2 products

4 indications

Organization

Instituto Venezolano de Investigaciones Cientificas

Product

Transplantation of autologous MSCs

Indication

Pseudoarthrosis of Bone

Indication

Nonunion

Indication

Non-union Fracture

Indication

Nonunion Bone Fracture

Product

Transplantation of allogeneic MSCs