Safety and Efficacy Study of Umbilical Mesenchymal Stem Cells for Liver Cirrhosis

NCT01573923 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2015-04-14

No results posted yet for this study

Summary

Liver cirrhosis and subsequent liver failure are leading causes of morbidity and mortality worldwide. Alcohol abuse and viral hepatitis are the most common causes of cirrhosis. Novel therapies are necessary to prevent or block the process of the disease. In this current prospective cohort, the investigators plan to organize four hospitals to determine the safety and efficacy of intravenous administration of umbilical mesenchymal stem cells in the treatment of patients with liver cirrhosis in next three years.

Conditions

Interventions

BIOLOGICAL

mesenchymal stem cells

Conventional therapy plus UC-MSC intravenous administration (4x107/40ml, once per three months, four times in one year)

BIOLOGICAL

Conventional therapy

Conventional therapy without cell therapy

Sponsors & Collaborators

  • Alliancells Bioscience Corporation Limited

    lead INDUSTRY

Principal Investigators

  • Xuetao Pei, MD,PhD · Chinese Industry and Innovative Technology Strategic Alliance of Stem Cells and Regenerative Medicine

  • Yongjun Liu, MD,PhD · Alliancells Bioscience Corporation Limited

  • Mingyuan Wu, MD,PhD · Eastern Union Stem Cell & Gene Engineering Co.,Ltd, Alliancells Bioscience Corporation Limited

  • Hanwei Li, MD,PhD · The 302 Hospital of Chinese People's Liberation Army

  • Liming Wang, MD · The 323 Hospital of Chinese People's Liberation Army

  • Xun Li, MD,PhD · LanZhou University

  • Liming Chen, MD,PhD · ongji Hospital of Tongji University

  • Jianwei Lu, MD · Tongji Hospital

  • Hui Shi, MD · The First People's Hospital of Lianyungang

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-07-31
Completion
2015-10-31

Countries

  • China

Study Locations

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Entities

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 NCT01573923 on ClinicalTrials.gov