drugset / Trial / NCT06623240
HB-adMSCs vs Placebo for the Treatment of Juvenile Idiopathic Arthritis
RandomizedCrossoverQuadruple-blindTreatment
Summary
Methodology: Randomized, double-blind, AB/BA cross-over study with a washout period of 12 weeks. Treatment Duration: 8 weeks per group General Objectives: To assess the efficacy and safety of multiple intravenous infusions of allogeneic HB-adMSCs by improving signs and symptoms of juvenile idiopathic arthritis in this subject population. Number of Subjects: 66 (6 subjects in Cohort 1 and 60 subjects in Cohort 2) Indication: Juvenile Idiopathic Arthritis
Timeline
- Start
- 2026-01
- Primary completion
- 2026-01
- Completion
- 2026-01
Outcome
Outcome not reported
Stopped (Enrollment): “In the time that the site has been active, there have been 0 patients enrolled despite our best efforts. It is clear that it is not feasible to conduct this study at this time; therefore, we have withdrawn this study.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HB-adMSCs | Cell therapy | 5e+07 cells | Intravenous |
| Subject | HB-adMSCs | Cell therapy | 1e+08 cells | Intravenous |
| Subject | HB-adMSCs | Cell therapy | 2e+08 cells | Intravenous |