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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.
Details
| Lead sponsor | Royan Institute |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | UNKNOWN |
| Enrolment | 60 |
| Start date | 2015-06 |
| Completion | 2017-08 |
Conditions
- Bone Fracture
Interventions
- Percutaneous injection
- Percutaneous injection
Primary outcomes
- clinical union — 3months
\- Clinical union is defined as an asymptomatic patient who was able to fully bear weight on the injured leg - Radiological healing — 1week
\- radiographic fracture healing is defined by bone continuity (bony bridging) present in three out of four cortices in two projections (anterior-posterior \& lateral x-rays), assessed by a blinded senior orthopedic surgeon. CT scan, for confirm the results - radiolographic fracture healing is defined by bone continuity (bony bridging) present in three out of four cortices in two projections (anterior-posterior \& lateral x-rays), assessed by a blinded senior orthopedic surgeon. CT scan, for confirm the results \- radiolographic fracture healing is defined by bone continuity (bony bridging) present in three out of four cortices in two projections (anterior-posterior \& lateral x-rays), assessed by a blinded senior orthopedic surgeon. CT scan, for confirm the results
Countries
Iran