Safety Study of Stemchymal® in Acute Liver Failure
Phase 1
Withdrawn
- Conditions
- Acute Liver FailureSteminentStem CellsAdult Stem CellsAcute-On-Chronic Liver Failure
- Interventions
- Biological: Stemchymal®
- Registration Number
- NCT03629015
- Lead Sponsor
- Steminent Biotherapeutics Inc.
- Brief Summary
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
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- ALF or ACLF patients.
- Subjects are between 20 and 70 years of age.
- MELD scores meet 17 ≤ MELD ≤ 26.
- Subjects who had completed signing informed consent.
Exclusion Criteria
- Subjects who had been enrolled in any other cell therapy within six months.
- Females with a positive pregnancy test result.
- Subjects have contraindication for liver transplantation.
- Subjects with psychiatric illnesses.
- Subjects who are diagnosed as active tuberculosis (TB).
- Subjects with immunological disorders (e.g. autoimmune hepatitis) or using immunosuppressive drugs (e.g. steroid for immunosuppression) within six months prior to screening visit.
- Subjects with unstable illnesses or contraindication for this clinical trial according to investigator's judgment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Stemchymal® 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
- Primary Outcome Measures
Name Time Method The incidence of adverse events (AEs) and suspected unexpected serious adverse reaction (SUSAR) 12 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan