Safety Study of Stemchymal® in Acute Liver Failure

Acute-On-Chronic Liver Failure Clinical Trial

— ALF  

Official 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03629015
• Other study ID #: AA01
• Status: Withdrawn
• Phase: Phase 1
• 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
• 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• Status: Withdrawn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.

Related Conditions & MeSH terms

• Acute Liver Failure
• Acute-On-Chronic Liver Failure
• Adult Stem Cells
• End Stage Liver Disease
• Hepatic Insufficiency
• Liver Failure
• Liver Failure, Acute
• Stem Cells
• Steminent

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