UnknownPhase 1/2

Treatment of Nonunion Fractures With Mesenchymal Stromal Cells (MSCs)

Venezuela30 participantsStarted 2018-01-30

Plain-language 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.

Who can participate

Age range10 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Clinical evaluation

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

Bone consolidation

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

Trial details

NCT IDNCT06103396

SponsorInstituto Venezolano de Investigaciones Cientificas

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-01-30

View on ClinicalTrials.gov More Pseudoarthrosis of Bone trials