drugset / Trial / NCT03254758

A Study of ADR-001 in Patients With Liver Cirrhosis

NCT03254758 ↗

Phase 1/2 Completed 21 enrolled Rohto Pharmaceutical Co., Ltd.
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

EvaluationDrugModalityDoseRoute
Subject ADR-001 Cell therapy — Intravenous

Indications