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Clinical Trial Details — Status: Withdrawn

Administrative data

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Status Withdrawn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

Study information

Verified date October 2022
Source Steminent Biotherapeutics Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Withdrawn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.

Study Design


Intervention

Biological:
Stemchymal®
ALF/ ACLF patients will receive Stemchymal® through intravenous infusion

Locations

Country Name City State
Taiwan Taipei Veterans General Hospital Taipei

Sponsors (2)

Lead Sponsor Collaborator
Steminent Biotherapeutics Inc. Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

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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