drugset / Trial / NCT02448849

Autologous BM-MSC Transplantation in Combination With Platelet Lysate (PL) for Nonunion Treatment

NCT02448849

Phase 2/3 Unknown 60 enrolled Royan Institute
RandomizedParallel-groupDouble-blindTreatment

Summary

Nonunion of long bones would occur in almost 10% of fractures and because of its long term and complicated treatment, is known as a therapeutic challenge for both of the surgeons and patients. Cell therapy is useful in treatment of nonunion and mesenchymal stromal/stem cells are the best candidates for this kind of treatment. Percutaneous implantation of autologous bone marrow derived mesenchymal stromal/stem cell in combination with PL will be done in 30 patients with tibia nonunion. The other 30 patients as the control group will receive placebo. The patients will be followed at 2weeks, 3months, 6m and 12 months after implantation. The Spss(v16) software will be used for data analysis.

Timeline

Start
2015-06
Primary completion
2017-04
Completion
2017-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Mesenchymal stem cell Cell therapy Other