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

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Status and phase: Withdrawn; Phase 1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

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.

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®