Safety Study of Stemchymal® in Acute Liver Failure

NCT ID: NCT03629015

Last Updated: 2022-10-28

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

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2020-05-18

Brief Summary

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To investigate the safety of Stemchymal® via intravenous (IV) infusion in acute liver failure (ALF) and acute on chronic liver failure (ACLF) patients.

Detailed Description

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Conditions

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Stem Cells Adult Stem Cells Acute Liver Failure Acute-On-Chronic Liver Failure Steminent

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stemchymal®

Biological: Stemchymal® ALF/ ACLF patients will receive low (0.5 x 10\^6 cells/kg) or high (2 x 10\^6 cells/kg) dose of Stemchymal® through intravenous infusion

Group Type EXPERIMENTAL

Stemchymal®

Intervention Type BIOLOGICAL

ALF/ ACLF patients will receive Stemchymal® through intravenous infusion

Interventions

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Stemchymal®

ALF/ ACLF patients will receive Stemchymal® through intravenous infusion

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. ALF or ACLF patients.
2. Subjects are between 20 and 70 years of age.
3. MELD scores meet 17 ≤ MELD ≤ 26.
4. Subjects who had completed signing informed consent.

Exclusion Criteria

1. Subjects who had been enrolled in any other cell therapy within six months.
2. Females with a positive pregnancy test result.
3. Subjects have contraindication for liver transplantation.
4. Subjects with psychiatric illnesses.
5. Subjects who are diagnosed as active tuberculosis (TB).
6. Subjects with immunological disorders (e.g. autoimmune hepatitis) or using immunosuppressive drugs (e.g. steroid for immunosuppression) within six months prior to screening visit.
7. Subjects with unstable illnesses or contraindication for this clinical trial according to investigator's judgment.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role collaborator

Steminent Biotherapeutics Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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AA01

Identifier Type: -

Identifier Source: org_study_id

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