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Study of Decompensated Alcoholic Cirrhosis Treatment by Stem Cells

NCT05155657 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-03-28

No results posted yet for this study

Summary

The main purpose of this study is to evaluate the safety and tolerance of umbilical cord mesenchymal stem cells (UCMSCs) in patients with decompensated alcoholic cirrhosis, and to provide dose basis for subsequent clinical study design. We will also explore the possible mechanism of UCMSCs in the treatment of decompensated alcoholic cirrhosis (DAC).

Conditions

  • Alcoholic Cirrhosis

Interventions

BIOLOGICAL

Conventional therapy plus low dose UCMSCs treatment

Patients will receive the conventional therapy plus low dose UCMSCs treatment (0.5×10\^6 UCMSCs/kg body)

BIOLOGICAL

Conventional therapy plus medium dose UCMSCs treatment

Patients will receive conventional therapy plus medium dose UCMSCs treatment (1×10\^6 UCMSCs/kg body)

BIOLOGICAL

Conventional therapy plus high dose UCMSCs treatment

Patients will receive conventional therapy plus high dose UCMSCs treatment (2×10\^6 UCMSCs/kg body)

Sponsors & Collaborators

  • Yantai Yuhuangding Hospital

    lead OTHER

Principal Investigators

  • Jun Cui, MD · Yantai Yuhuangding Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2022-06-13
Primary Completion
2024-12-25
Completion
2024-12-25

Countries

  • China

Study Locations

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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 NCT05155657 on ClinicalTrials.gov