Autologous BM-MSC Transplantation in Combination With Platelet Lysate (PL) for Nonunion Treatment
- Conditions
- Bone Fracture
- Interventions
- Other: Percutaneous injection
- Registration Number
- NCT02448849
- Lead Sponsor
- Royan Institute
- Brief 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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MSC recipients Percutaneous injection The patients with nonunion fracture who underwent percutaneous implantation of bone marrow derived mesenchymal stem cells in combination with platelet lysate product. Placebo Percutaneous injection The patients with nonunion fracture who underwent percutaneous injection of placebo.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Pain 3months The pain relief as measured by Visual Analogue Scale (VAS) 3 months after cell injection
Quality of life 3months Evaluation the patients' quality of life with Visual Analogue Score (VAS) 3months after cell transplantation.
Walking distance 3months Walking distance changes as measured by walking on treadmill 3 months after cell injection.
Trial Locations
- Locations (1)
Royan Institute
🇮🇷Tehran, Iran, Islamic Republic of