Autologous BM-MSC Transplantation in Combination With Platelet Lysate (PL) for Nonunion Treatment
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MSC recipients The patients with nonunion fracture who underwent percutaneous implantation of bone marrow derived mesenchymal stem cells in combination with platelet lysate product. |
Biological: Percutaneous injection
percutanous implantation of bone marrow derived mesenchymal stromal cells in patients with nonunion fracture.
|
| Placebo Comparator: Placebo The patients with nonunion fracture who underwent percutaneous injection of placebo. |
Other: Percutaneous injection
Percutaneous implantation of placebo in patients with nonunion fracture.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
inclusion criteria:
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Non-united fracture of tibial midshaft at X-ray.
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Non-united gap less than 1cm.
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Fracture has fixed by closed intramedullary rod.
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Hypotrophic type.
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At least 6 months after initial surgery.
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Patient informed consent.
Exclusion criteria:
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Infected nonunion
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Multiple major fracture
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Non treated major fracture
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malignancy
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Pregnancy or lactating
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Uncontrolled chronic diseases, such as: diabetes mellitus, hypertension, renal diseases, liver diseases, thyroid diseases, heart diseases, blood diseases, etc.
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Steroid usage.
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Positive test for HIV and/or HBS and/or HBC and/or HTLV (1,2)
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Fracture site more than 1 cm.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Royan Institute | Tehran | Iran, Islamic Republic of |
Sponsors and Collaborators
- Royan Institute
Investigators
- Study Chair: Hamid Gourabi, PhD, Head of Royan Institute
- Study Director: Nasser Aghdami, MD,PhD, Head of Regenerative medicine department and cell therapy center of Royan Institute
- Study Director: Mohammad Razi, MD, Department of orthopedic surgery, Tehran university of medical science, Tehran, Iran
- Principal Investigator: Mohsen Emadedin, MD, Cell therapy center of Royan Institute
- Principal Investigator: Narges Labibzadeh, MD, Department of Regenerative Medicine and cell therapy center, Royan Institute
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- Royan-Bone-013