Acute Liver Failure, Acute-On-Chronic Liver Failure, Adult Stem Cells, Stem Cells, Steminent
Conditions
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.
Interventions
BIOLOGICALStemchymal®
ALF/ ACLF patients will receive Stemchymal® through intravenous infusion
Sponsors
Taipei Veterans General Hospital, Taiwan
Steminent Biotherapeutics Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of adverse events (AEs) and suspected unexpected serious adverse reaction (SUSAR) | 12 months |
Other
| Measure | Time frame |
|---|---|
| Changes of Model for End-Stage Liver Disease score | 12 months |
| Changes of Child-Pugh score | 12 months |
| Changes of Eastern Cooperative Oncology Group performance scale | 12 months |
Countries
Taiwan
Outcome results
None listed