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
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Royan Institute
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- clinical union
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Non-united fracture of tibial midshaft at X-ray.
- •Non-united gap less than 1cm.
- •Fracture has fixed by closed intramedullary rod.
- •Hypotrophic type.
- •At least 6 months after initial surgery.
- •Patient informed consent.
Exclusion Criteria
- •Infected nonunion
- •Multiple major fracture
- •Non treated major fracture
- •malignancy
- •Pregnancy or lactating
- •Uncontrolled chronic diseases, such as: diabetes mellitus, hypertension, renal diseases, liver diseases, thyroid diseases, heart diseases, blood diseases, etc.
- •Steroid usage.
- •Positive test for HIV and/or HBS and/or HBC and/or HTLV (1,2)
- •Fracture site more than 1 cm.
Arms & Interventions
MSC recipients
The patients with nonunion fracture who underwent percutaneous implantation of bone marrow derived mesenchymal stem cells in combination with platelet lysate product.
Intervention: Percutaneous injection (Biological)
Placebo
The patients with nonunion fracture who underwent percutaneous injection of placebo.
Intervention: Percutaneous injection (Other)
Outcomes
Primary Outcomes
clinical union
Time Frame: 3months
- Clinical union is defined as an asymptomatic patient who was able to fully bear weight on the injured leg
Radiological healing
Time Frame: 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 Outcomes
- Pain(3months)
- Quality of life(3months)
- Walking distance(3months)