Status:
UNKNOWN
Treatment of Nonunion Fractures With Mesenchymal Stromal Cells (MSCs)
Lead Sponsor:
Instituto Venezolano de Investigaciones Cientificas
Collaborating Sponsors:
Hospital Central Dr. Plácido D. Rodriguez Rivero
Instituto Autónomo Hospital Universitario de la Universidad de Los Andes
Conditions:
Pseudoarthrosis of Bone
Pseudarthrosis
Eligibility:
All Genders
10-85 years
Phase:
PHASE1
PHASE2
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, in...
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, li...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06103396
Start Date
January 30 2018
End Date
December 30 2024
Last Update
October 31 2023
Active Locations (1)
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1
Instituto Venezolano de Investigaciones Cientificas
Caracas, Miranda, Venezuela, 1204