NCT02448849

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

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Royan Institute · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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).

Conditions

• Bone Fracture

Interventions

Type	Name	Description
BIOLOGICAL	Percutaneous injection	percutanous implantation of bone marrow derived mesenchymal stromal cells in patients with nonunion fracture.
OTHER	Percutaneous injection	Percutaneous implantation of placebo in patients with nonunion fracture.

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-04-01
• Completion: 2017-08-01
• First posted: 2015-05-20
• Last updated: 2015-10-30

Locations

1 site across 1 country: Iran