Safety Study of Stemchymal® in Acute Liver Failure (ALF)

The Safety Study of Stemchymal® (Allogeneic Adipose-Derived Mesenchymal Stem Cells) Treating on Acute Liver Failure - An Open-Label, Single-Center Phase I Trial

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

Study Overview

• Status: Withdrawn
• Conditions: Acute-On-Chronic Liver Failure; Acute Liver Failure; Stem Cells; Adult Stem Cells; Steminent
• Intervention / Treatment: Biological: Stemchymal®

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Taipei Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stemchymal®; 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	Biological: Stemchymal®; ALF/ ACLF patients will receive Stemchymal® through intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The incidence of adverse events (AEs) and suspected unexpected serious adverse reaction (SUSAR)	12 months

Other Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Steminent Biotherapeutics Inc.
• Collaborators: Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2018
• Primary Completion (Actual): May 18, 2020
• Study Completion (Actual): May 18, 2020

Study Registration Dates

• First Submitted: July 30, 2018
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (Actual): August 14, 2018

Study Record Updates

• Last Update Posted (Actual): October 28, 2022
• Last Update Submitted That Met QC Criteria: October 26, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; End Stage Liver Disease; Liver Failure; Hepatic Insufficiency; Acute-On-Chronic Liver Failure; Liver Failure, Acute
• Other Study ID Numbers: AA01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No