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

NCT ID: NCT02806011

Last Updated: 2020-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2020-10-31

Brief Summary

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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).

Detailed Description

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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.).

Conditions

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Alcoholic Liver Cirrhosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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no Intervention

Long-term follow up of no intervention group

No interventions assigned to this group

1-time injection group

Long-term follow up of 1-time injection group

No interventions assigned to this group

2-time injection group

Long-term follow up of 2-time injection group

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pharmicell Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Soon Koo Baik, M.D.,Ph.D

Role: PRINCIPAL_INVESTIGATOR

Wonju Severance Christian Hospital

Locations

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Wonju Severance Christian Hospital

Wŏnju, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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PMC-P-002-01

Identifier Type: -

Identifier Source: org_study_id