drugset / Trial / NCT05081921
Clinical Trial to Evaluate Safety and Efficacy of MesoCellA-Ortho Tissue-Engineered Advanced Therapy Product in Patients With Osteoarthrosis and Civilisation Diseases
Phase 1/2
Completed
192 enrolled
Jagiellonian University
KCRI · collabNational Center for Research and Development, Poland · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The aim of the study is to evaluate safety, tolerability and clinical efficacy of a newly developed MesoCellA-Ortho tissue-engineered advanced therapy medicinal product in adult patients suffering with osteoarthritis and additionally burdened with other civilisation diseases such as type 2 diabetes and/ or obesity. The active substance of MesoCellA-Ortho consists of in vitro expanded autologous human adipose tissue-derived mesenchymal stem/ stromal cells (AT-MSCs) resuspended in carrier solution for intraarticular injections for individual patents.
Timeline
- Start
- 2022-01-05
- Primary completion
- 2024-02-20
- Completion
- 2024-02-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Hyaluronic Acid | Other / unclassified | — | Other |
| Subject | MesoCellA-Ortho | Cell therapy | 2e+07 cells | Other |