Safety Study of Stemchymal® in Acute Liver Failure | NCT03629015

Studies
Safety Study of Stemchymal® in Acute Liver Failure

NCT03629015

Sponsor

Steminent Biotherapeutics Inc.

Status

Withdrawn

Last Update Posted

Oct 28, 2022Actual

Enrollment

0Actual

Phase

Phase 1

Conditions

Stem Cells
Adult Stem Cells
Acute Liver Failure
Acute-On-Chronic Liver Failure
Steminent

Interventions

Stemchymal®

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Corporate strategic consideration

Expanded Access Info

Start Date

Oct 1, 2018Estimated

Primary Completion Date

May 18, 2020Actual

Completion Date

May 18, 2020Actual

First Submitted Date

Jul 30, 2018

First Submission Date that Met QC Criteria

Aug 9, 2018

First Posted Date

Aug 14, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2022

Last Update Posted Date

Oct 28, 2022Actual

Name	Class
Taipei Veterans General Hospital, Taiwan	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Stemchymal®	Biological	ALF/ ACLF patients will receive Stemchymal® through intravenous infusion	Stemchymal®

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taipei Veterans General Hospital		Taipei			Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017114	Liver Failure, Acute
D065290	Acute-On-Chronic Liver Failure

Ancestor Terms

ID	Term
D017093	Liver Failure
D048550	Hepatic Insufficiency
D008107	Liver Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided