ALF: Safety Study of Stemchymal® in Acute Liver Failure

• Sponsor: Steminent Biotherapeutics Inc. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT03629015
• Collaborator: Taipei Veterans General Hospital, Taiwan (Other)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 25
• Patients Per Site Per Month: 0.8

Study Details

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.

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

• Study Type: Interventional
• Anticipated 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
• Anticipated Study Start Date: Oct 1, 2018
• Anticipated Primary Completion Date: Feb 29, 2020
• Anticipated Study Completion Date: Oct 31, 2020

Arms and Interventions

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

Primary Outcome Measures

1. The incidence of adverse events (AEs) and suspected unexpected serious adverse reaction (SUSAR) [12 months]

Other Outcome Measures

1. Changes of Model for End-Stage Liver Disease score [12 months]

2. Changes of Child-Pugh score [12 months]

3. Changes of Eastern Cooperative Oncology Group performance scale [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Taipei Veterans General Hospital	Taipei		Taiwan

Sponsors and Collaborators

• Steminent Biotherapeutics Inc.
• Taipei Veterans General Hospital, Taiwan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Steminent Biotherapeutics Inc.
• ClinicalTrials.gov Identifier: NCT03629015
• Other Study ID Numbers: AA01
• First Posted: Aug 14, 2018
• Last Update Posted: Aug 14, 2018
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Liver Failure; Hepatic Insufficiency; End Stage Liver Disease; Acute-On-Chronic Liver Failure; Liver Failure, Acute

Study Results

No Results Posted as of Aug 14, 2018