Long-term Follow-up Study of Livercellgram in Alcoholic LC Patients Who Completed Livercellgram Phase 2 Study

Pharmicell

Status: Completed

Conditions: Alcoholic Liver Cirrhosis

Study type: Observational

Funder types: Industry

Identifiers

NCT02806011

PMC-P-002-01

Details and patient eligibility

About

This is a 5-year (+30 days) long term follow up study to evaluate the safety of Livercellgram in subject who participated in and completed the Livercellgram Phase 2 trials (refer to ClinicalTrials.gov.Identifier: NCT01875081).

Full description

This is a 5-year (+30 days) long term follow up study to evaluate the safety of Livercellgram in subject who participated in and completed the Livercellgram Phase 2 trials (refer to ClinicalTrials.gov.Identifier: NCT01875081).

This trial is planned to evaluate the safety of Livercellgram in patients with alcoholic liver cirrhosis. Subjects who signed this follow-up observation informed consent form will participate in a safety assessment (tumor marker test, occurrence of adverse events and serious adverse events, clinical laboratory tests, vital sign, physical examinations.).

Enrollment: 48 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects who treated with Livercellgram and completed the Livercellgram phase 2 study.
2. Subjects who can agree to participate in the long term observation study by oneself.

Exclusion criteria

• Not Applicable

Trial design

48 participants in 3 patient groups

no Intervention

Description:

Long-term follow up of no intervention group

1-time injection group

Description:

Long-term follow up of 1-time injection group

2-time injection group

Description:

Long-term follow up of 2-time injection group