An Follow-Up Study of Liver Cirrhosis

ROHTO Pharmaceutical

Status: Completed

Conditions: Decompensated Liver Cirrhosis

Treatments: Drug: Mesenchymal Stem Cell

Study type: Observational

Funder types: Industry

Identifiers

NCT03472742

ADR-001-02

Details and patient eligibility

About

This is a follow-up study to assess safety and preliminary clinical activity of ADR-001 in patients with liver cirrhosis (Child-Pugh score; Grade B) caused by Hepatitis C or Nonalcoholic Steatohepatitis. Patients who have already participated in the ADR-001-01 study and completed the last evaluation after 24 weeks of administration will be eligible to this study.

Patients registered will continue follow-up observation and evaluate long-term safety and exploratory efficacy.

Enrollment: 19 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Liver cirrhosis patients enrolled in ADR-001-01 study and completed the last observation of the study
• Voluntary signed informed consent

Exclusion criteria

• Patients evaluated by investigators as inappropriate