Nonunion Bone Fracture, Non Union Fracture, Pseudarthrosis, Pseudoarthrosis of Bone
Conditions
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.
Interventions
BIOLOGICALTransplantation 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.)
BIOLOGICALTransplantation 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.)
Sponsors
Hospital Central Dr. Plácido D. Rodriguez Rivero
Instituto Autónomo Hospital Universitario de la Universidad de Los Andes
Instituto Venezolano de Investigaciones Cientificas
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Venezuela
Outcome results
None listed