drugset / Trial / NCT06103396
Treatment of Nonunion Fractures With Mesenchymal Stromal Cells (MSCs)
Phase 1/2
Unknown
30 enrolled
Venezuelan Institute for Scientific Research
Hospital Central Dr. Plácido D. Rodriguez Rivero · collabInstituto Autónomo Hospital Universitario de la Universidad de Los Andes · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2018-01-30
- Primary completion
- 2022-01-30
- Completion
- 2024-12-30
Publications
- Background 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.
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Autologous MSCs | Cell therapy | — | Other |
| Subject | allogeneic MSCs | Cell therapy | — | Other |