NCT03629015WithdrawnPhase 1
The Safety Study of Stemchymal® (Allogeneic Adipose-Derived Mesenchymal Stem Cells) Treating on Acute Liver Failure - An Open-Label, Single-Center Phase I Trial
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- The incidence of adverse events (AEs) and suspected unexpected serious adverse reaction (SUSAR)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ALF or ACLF patients.
- •Subjects are between 20 and 70 years of age.
- •MELD scores meet 17 ≤ MELD ≤
- •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.
Arms & Interventions
Stemchymal®
Experimental
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
Intervention: Stemchymal® (Biological)
Outcomes
Primary Outcomes
The incidence of adverse events (AEs) and suspected unexpected serious adverse reaction (SUSAR)
Time Frame: 12 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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