Bone Fracture Clinical Trial
Official title:
Use of Autologous Bone Marrow Derived Mesenchymal Stromal Cells in Combination With Platelet Lysate Product for Human Long Bone Nonunion Treatment, A Phase 2-3 Clinical Trial
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.
Long bone nonunion is known as a therapeutic challenge for both the orthopedic surgeons and
the society. Current treatment of this disorder is autologous bone graft. This treatment has
potential minor and major complications and is considered as a risky treatment. So
researches are focused on new treatment approaches for this disease.
Cell therapy is one of these new approaches especially based on mesenchymal stromal cells.
The investigators will evaluate safety and efficacy of percutaneous implantation of
autologous BM-MSC (bone marrow -derived mesenchymal stromal cell) in combination with PL
(platelet lysate product) in 30 tibia nonunion patients. The other 30 patients will receive
placebo. These patients will be followed up and data will be analyzed with spss(v16).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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