drugset / Trial / NCT03254758
A Study of ADR-001 in Patients With Liver Cirrhosis
NaSingle-groupOpen-labelTreatment
Summary
This is a first-in-human Phase1/2 study of ADR-001, adipose-derived mesenchymal stem cells (AD-MSCs). The safety and preliminary efficacy are evaluated in Phase 1 in patients with liver cirrhosis caused by Hepatitis C or Nonalcoholic Steatohepatitis and a recommended Phase 2 dose is determined by the evaluation. The exploratory efficacy and safety are investigated against the same target population in Phase 2.
Timeline
- Start
- 2017-07-20
- Primary completion
- 2023-04-13
- Completion
- 2023-04-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ADR-001 | Cell therapy | — | Intravenous |