NCT03629015

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2020

Completed
Last Updated

October 28, 2022

Status Verified

October 1, 2022

Enrollment Period

1.6 years

First QC Date

July 30, 2018

Last Update Submit

October 26, 2022

Conditions

Stem CellsAdult Stem CellsAcute Liver FailureAcute-On-Chronic Liver FailureSteminent

Outcome Measures

Primary Outcomes (1)

  • The incidence of adverse events (AEs) and suspected unexpected serious adverse reaction (SUSAR)

    12 months

Other Outcomes (3)

  • 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

Study Arms (1)

Stemchymal®

EXPERIMENTAL

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®

Interventions

Stemchymal®BIOLOGICAL

ALF/ ACLF patients will receive Stemchymal® through intravenous infusion

Stemchymal®

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ALF or ACLF patients.
  • Subjects are between 20 and 70 years of age.
  • MELD scores meet 17 ≤ MELD ≤ 26.
  • Subjects who had completed signing informed consent.

You may not qualify if:

  • Subjects who had been enrolled in any other cell therapy within six months.
  • Females with a positive pregnancy test result.
  • Subjects have contraindication for liver transplantation.
  • Subjects with psychiatric illnesses.
  • Subjects who are diagnosed as active tuberculosis (TB).
  • Subjects with immunological disorders (e.g. autoimmune hepatitis) or using immunosuppressive drugs (e.g. steroid for immunosuppression) within six months prior to screening visit.
  • Subjects with unstable illnesses or contraindication for this clinical trial according to investigator's judgment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Liver Failure, AcuteAcute-On-Chronic Liver Failure

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System Diseases
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2018

First Posted

August 14, 2018

Study Start

October 1, 2018

Primary Completion

May 18, 2020

Study Completion

May 18, 2020

Last Updated

October 28, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)