drugset / Trial / NCT07703280
Intra Articular Injection of Peripheral Blood Mononuclear Cells for Knee Osteoarthritis
Phase 2/3
Not yet recruiting
240 enrolled
DuoGenic StemCells Corporation (DGSC)
Chang Gung Memorial Hospital, Chiayi · collabKaoshiung Chang Gung Memorial Hospital · collabNational Cheng-Kung University Hospital · collabNational Taiwan University Hospital · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The goal of this Phase II/III, double-blinded, multicenter clinical trial is to assess the clinical efficacy of autologous peripheral blood mononuclear cells (PBMCs) in the management of knee osteoarthritis (KOA). The main questions it aims to answer are: 1. To determine the safety of the PCP-PBMCs injection 2. To compare the long-term efficacy between PCP-PBMCs and methylprednisolone on pain relief and motor function restoration 3. To analyze improving quality of life after the PCP-PBMCs treatment.
Timeline
- Start
- 2026-09-30
- Primary completion
- 2028-12-31
- Completion
- 2029-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Methylprednisolone | Other / unclassified | 4 ml | Other |
| Subject | PCP-PBMCs | Cell therapy | 4 ml | Other |
| Subject | PCP-PBMCs | Cell therapy | 2e+07 cells | Other |
| Subject | PCP-PBMCs | Cell therapy | 6e+07 cells | Other |
| Subject | PCP-PBMCs | Cell therapy | 1e+08 cells | Other |
| Subject | PCP-PBMCs | Cell therapy | 2e+08 cells | Other |