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

Primary Purpose

Stem Cells, Adult Stem Cells, Acute Liver Failure

Status
Withdrawn
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
Stemchymal®
Sponsored by
Steminent Biotherapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stem Cells

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stemchymal®

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 30, 2018
Last Updated
October 26, 2022
Sponsor
Steminent Biotherapeutics Inc.
Collaborators
Taipei Veterans General Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT03629015
Brief Title
Safety Study of Stemchymal® in Acute Liver Failure
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Corporate strategic consideration
Study Start Date
October 1, 2018 (Anticipated)
Primary Completion Date
May 18, 2020 (Actual)
Study Completion Date
May 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Steminent Biotherapeutics Inc.
Collaborators
Taipei Veterans General Hospital, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stem Cells, Adult Stem Cells, Acute Liver Failure, Acute-On-Chronic Liver Failure, Steminent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stemchymal®
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Stemchymal®
Intervention Description
ALF/ ACLF patients will receive Stemchymal® through intravenous infusion
Primary Outcome Measure Information:
Title
The incidence of adverse events (AEs) and suspected unexpected serious adverse reaction (SUSAR)
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Changes of Model for End-Stage Liver Disease score
Time Frame
12 months
Title
Changes of Child-Pugh score
Time Frame
12 months
Title
Changes of Eastern Cooperative Oncology Group performance scale
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Safety Study of Stemchymal® in Acute Liver Failure

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