Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06574581 | ADSCs Therapy in Patients With CTD-ILD | PHASE1 | RECRUITING | 16 | — | — | Aug 20, 2024 | Nov 30, 2027 | May 13, 2026 | 1 | Taiwan |
1. Stable blood pressure: systolic pressure 90-120mmHg and diastolic pressure 60-80mmHg measured after resting for 10 minutes 2. Stable pulse rate: ranges 60-100/minute after resting for 10 minutes 3. Stable respiratory rate: ranges 12-20/minute after resting for 10 minutes 4. Normal body temperature 35.7℃-37.9℃. 5. Resting oxygen saturation≧90% without oxygen use. 6. Absence of AD-MSCs infusion-related serious adverse event.
| Arm | Type | Description |
|---|---|---|
| ADSC01 | EXPERIMENTAL | 1. Low-dose AD-MSC (1x10E6 cells/kg); 2. Medium-dose AD-MSC (2x10E6 cells/kg) 3. High-dose AD-MSC (3x10E6 cells/kg) |
| Name | Type | Description |
|---|---|---|
| ADSC01 | BIOLOGICAL | The initial 3 subjects will receive low-dose AD-MSC (1x10E6 cells/kg) infusion therapy only once; if no adverse events after 4 weeks, the next 4-7 subjects will receive medium-dose AD-MSC (1x10E6 cells/kg) infusion therapy twice; if no adverse events after 4 weeks of the last infusion, the next 8-10 subjects will receive high-dose AD-MSC (1x10E6 cells/kg) infusion therapy three times. |
Inclusion Criteria: 1. Adult subjects aged between 20 and 80 years who meet the diagnostic criteria for connective tissue diseases such as dermatomyositis, polymyositis, scleroderma, systemic lupus erythematosus, rheumatoid arthritis, or Sjogren's syndrome. 2. Subjects with refractory or progressiv...