Pseudarthrosis Clinical Trial
— MSCOfficial title:
Treatment of Nonunion After Fractures (Pseudoartrosis) Using Mesenchymal Stromal Cells (MSCs)
Verified date | October 2023 |
Source | Instituto Venezolano de Investigaciones Cientificas |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this study is to evaluate the bone regeneration capacity of BM-MSC (Bone marrow mesenchymal stromal cells), in patients with nonunion. BM-MSC cultured are seeded on a collagen scaffold, included into autologous platelet-rich plasma (PRP) clot, and implanted in the nonunion bone defect.
Status | Enrolling by invitation |
Enrollment | 30 |
Est. completion date | December 30, 2024 |
Est. primary completion date | January 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 85 Years |
Eligibility | Inclusion Criteria: - Post-traumatic nonunion diagnosis (Pseudoarthrosis) with or without previous ortopaedic treatment - Patients with or without previous orthopaedic treatment - Presence of nonunion 9 month or more - Ossification failure in the non-union area, with an approximate size of 0.5 to 4 cm length Exclusion Criteria: - Evidence of infection at the nonunion site (Osteomielitis) - Evidence of cutaneous lesion at the site of pseudoartrosis - Viral hepatitis B and C, HIV infection, syphilis and other viral and bacterial infections - Autoimmune diseases - Neoplastic diseases - Pregnancy - Major metabolic disorders - Treatment with steroids - Other conditions or circumstances that compromise the study participation according to medical criteria |
Country | Name | City | State |
---|---|---|---|
Venezuela | Instituto Venezolano de Investigaciones Cientificas | Caracas | Miranda |
Lead Sponsor | Collaborator |
---|---|
Instituto Venezolano de Investigaciones Cientificas | Hospital Central Dr. Plácido D. Rodriguez Rivero, Instituto Autónomo Hospital Universitario de la Universidad de Los Andes |
Venezuela,
Diaz-Solano D, Wittig O, Mota JD, Cardier JE. Isolation and Characterization of Multipotential Mesenchymal Stromal Cells from Congenital Pseudoarthrosis of the Tibia: Case Report. Anat Rec (Hoboken). 2015 Oct;298(10):1804-14. doi: 10.1002/ar.23198. Epub 2015 Jul 30. — View Citation
Wittig O, Diaz-Solano D, Cardier J. Viability and functionality of mesenchymal stromal cells loaded on collagen microspheres and incorporated into plasma clots for orthopaedic application: Effect of storage conditions. Injury. 2018 Jun;49(6):1052-1057. doi: 10.1016/j.injury.2018.04.005. Epub 2018 Apr 5. — View Citation
Wittig O, Romano E, Gonzalez C, Diaz-Solano D, Marquez ME, Tovar P, Aoun R, Cardier JE. A method of treatment for nonunion after fractures using mesenchymal stromal cells loaded on collagen microspheres and incorporated into platelet-rich plasma clots. Int Orthop. 2016 May;40(5):1033-8. doi: 10.1007/s00264-016-3130-6. Epub 2016 Mar 16. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical evaluation | Time of surgical wound evolution, surgically intervened limb evolution, movility | Baseline, 1 and 7 days. 1, 2 and 6 months. 1 and 2 years | |
Primary | Bone consolidation | Time of development changes in bone consolidation by radiological studies | Baseline, 1 and 7 days. 1, 2 and 6 months. 1 and 2 years |
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