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

S

Steminent Biotherapeutics

Status and phase

Withdrawn
Phase 1

Conditions

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

Treatments

Biological: Stemchymal®

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03629015
AA01

Details and patient eligibility

About

To investigate the safety of Stemchymal® via intravenous (IV) infusion in acute liver failure (ALF) and acute on chronic liver failure (ACLF) patients.

Sex

All

Ages

20 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Sequential Assignment

Masking

None (Open label)

0 participants in 1 patient group

Stemchymal®
Experimental group
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
Treatment:
Biological: Stemchymal®

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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