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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03629015
Recruitment Status : Unknown
Verified August 2018 by Steminent Biotherapeutics Inc..
Recruitment status was:  Not yet recruiting
First Posted : August 14, 2018
Last Update Posted : August 14, 2018
Sponsor:
Collaborator:
Taipei Veterans General Hospital, Taiwan
Information provided by (Responsible Party):
Steminent Biotherapeutics Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stem Cells Adult Stem Cells Acute Liver Failure Acute-On-Chronic Liver Failure Steminent Biological: Stemchymal® Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : February 29, 2020
Estimated Study Completion Date : October 31, 2020
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. The incidence of adverse events (AEs) and suspected unexpected serious adverse reaction (SUSAR) [ Time Frame: 12 months ]

Other Outcome Measures:
  1. Changes of Model for End-Stage Liver Disease score [ Time Frame: 12 months ]
  2. Changes of Child-Pugh score [ Time Frame: 12 months ]
  3. Changes of Eastern Cooperative Oncology Group performance scale [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03629015


Contacts
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Contact: Chih-Yuan Ho, PhD +886-2-26279216 ext 670 kevinho@steminent.com

Locations
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Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Sponsors and Collaborators
Steminent Biotherapeutics Inc.
Taipei Veterans General Hospital, Taiwan
More Information
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Responsible Party: Steminent Biotherapeutics Inc.
ClinicalTrials.gov Identifier: NCT03629015    
Other Study ID Numbers: AA01
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Failure
Hepatic Insufficiency
End Stage Liver Disease
Acute-On-Chronic Liver Failure
 Liver Failure, Acute
Liver Diseases
Digestive System Diseases