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

P

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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