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Human Umbilical Cord Mesenchymal Stem Cell Transplantation for The Treatment of Acute-on-Chronic Liver Failure

NCT05985863 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-05-07

No results posted yet for this study

Summary

This study is a randomized double-blind placebo-controlled multicenter clinical trial to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell (UC-MSC) transplantation for the treatment of acute-on-chronic liver failure (ACLF). UC-MSC therapy may improve the clinical outcomes of patients with ACLF. The trial would provide scientific evidence for UC-MSC transplantation as a potential treatment for ACLF.

Conditions

  • Acute-On-Chronic Liver Failure

Interventions

DRUG

standard medical treatment

standard medical treatment for ACLF

DRUG

Placebo

5% human serum albumin in 0.9% saline (at week0, week1 and week2)

DRUG

hUC-MSC

hUC-MSC (1.5×10\^8 cells/time, Peripheral IV, at week0, week1 and week2)

DRUG

hUC-MSC_Prolonged

hUC-MSC (1.5×10\^8 cells/time, Peripheral IV, at week4 and week5)

Sponsors & Collaborators

  • Shulan (Hang Zhou) Hospital

    collaborator UNKNOWN

  • BeijingYouan Hospital

    collaborator UNKNOWN

  • Shenzhen Third People's Hospital

    collaborator OTHER

  • Shen Zhen Wingor Biotechnology CO. LTD

    collaborator INDUSTRY

  • Beijing 302 Hospital

    lead OTHER

Principal Investigators

  • Ming Shi, PhD · the Fifth Medical Center, Chinese PLA General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-30
Primary Completion
2026-12-30
Completion
2028-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05985863 on ClinicalTrials.gov