Acute-On-Chronic Liver Failure Clinical Trial
— ALFOfficial title:
The Safety Study of Stemchymal® (Allogeneic Adipose-Derived Mesenchymal Stem Cells) Treating on Acute Liver Failure - An Open-Label, Single-Center Phase I Trial
NCT number | NCT03629015 |
Other study ID # | AA01 |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | October 1, 2018 |
Est. completion date | May 18, 2020 |
Verified date | October 2022 |
Source | Steminent Biotherapeutics Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To investigate the safety of Stemchymal® via intravenous (IV) infusion in acute liver failure (ALF) and acute on chronic liver failure (ACLF) patients.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 18, 2020 |
Est. primary completion date | May 18, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Taipei Veterans General Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Steminent Biotherapeutics Inc. | Taipei Veterans General Hospital, Taiwan |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Changes of Model for End-Stage Liver Disease score | 12 months | ||
Other | Changes of Child-Pugh score | 12 months | ||
Other | Changes of Eastern Cooperative Oncology Group performance scale | 12 months | ||
Primary | The incidence of adverse events (AEs) and suspected unexpected serious adverse reaction (SUSAR) | 12 months |
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