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Safety and Efficacy of SHED for Decompensated Liver Cirrhosis

NCT03957655 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-12-03

No results posted yet for this study

Summary

This study is an prospective, randomized control study. Patients with decompensated cirrhosis will be randomly assigned to receive 4 times of SHED treatment plus standard medical care(treatment）or standard medical care (control). The primary outcome is MELD-Na score. Secondary outcomes are Child-Pugh, liver function, life quality and survival.

Conditions

Interventions

BIOLOGICAL

SHED group

1x10E6 MSCs/kg body weight will be administered via peripheral vein for 4 times at week 0,4,8,12

Sponsors & Collaborators

  • Eastern Hepatobiliary Surgery Hospital

    collaborator OTHER

  • CAR-T (Shanghai) Biotechnology Co., Ltd.

    collaborator INDUSTRY

  • Changhai Hospital

    lead OTHER

Principal Investigators

  • Zhaoshen Li, Dr. · Changhai Hospital

  • Chengzhong Li, Dr. · Changhai Hospital

  • Lei Xin, Dr. · Changhai Hospital

  • Jianya Xue, Dr. · Changhai Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-12-02
Primary Completion
2020-12-31
Completion
2021-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT03957655 on ClinicalTrials.gov