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

April 12, 2015 updated by: Alliancells Bioscience Corporation Limited

Clinical Trial of Umbilical Mesenchymal Stem Cells Transplantation for Liver Cirrhosis-Phase I/II

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

320

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • The 302 Hospital of Chinese People's Liberation Army
        • Principal Investigator:
          • Hanwei Li, MD, PhD
    • Gansu
      • Lanzhou, Gansu, China
        • Recruiting
        • The First Affiliated Hospital of Lanzhou University
        • Contact:
          • Xun Li, MD, PhD
        • Principal Investigator:
          • Xun Li, MD
    • Hainan
      • Qionghai, Hainan, China, 571434
        • Recruiting
        • Hainan BOAO Life infinity international anti-aging medical center
        • Contact:
    • Jiangsu
      • Lianyungang, Jiangsu, China, 222002
        • Recruiting
        • The First People's Hospital of Lianyungang
        • Contact:
          • Hui Shi, MD
        • Principal Investigator:
          • Hui Shi, MD
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Tongji Hospital of Tongji University
        • Contact:
          • Liming Chen, MD, PhD
        • Principal Investigator:
          • Jianwei Lu, PhD
    • Shanxi
      • Xi'an, Shanxi, China, 710054
        • Recruiting
        • The 323 Hospital of Chinese People's Liberation Army
        • Contact:
        • Principal Investigator:
          • Liming Wang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • written informed consent
  • aged 30-60 years
  • clinical diagnosis of compensated or decompensated liver
  • child-Pugh B/C (7-12 points)
  • expecting lifetime is over three years

Exclusion Criteria:

  • pregnant woman
  • patient with severe vascular diseases
  • patient with any organ failure
  • patient with any tumors
  • patient with HIV
  • patient who has been transplanted
  • patient treated with immunosuppressors
  • patient for whom the follow-up is considered impossible
  • patients with any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Conventional therapy
only apply for conventional medical therapy without any cell therapy
Biological: Conventional therapy
Conventional therapy without cell therapy
Active Comparator: mesenchymal stem cells
combination of conventional therapy with umbilical mesenchymal stem cells intravenous injection, (4x107/40ml, once per three months, four times in one year)
Biological: mesenchymal stem cells
Conventional therapy plus UC-MSC intravenous administration (4x107/40ml, once per three months, four times in one year)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
survival time
Time Frame: 3-year follow up
3-year follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum markers regarding liver and kidney function
Time Frame: 0, 3, 6, 9 and 12 months
liver functions：Albumin (ALB), Alanine aminotransferase (ALT), Aspartate Aminotransferase (AST), Prealbumin(PA), total bilirubin (TB), and direct bilirubin (DB) kidney function：Blood urea nitrogen (BUN), Urea (UA), and Crea (Cr)
0, 3, 6, 9 and 12 months
Serum markers regarding lipid and sugar profile
Time Frame: 0, 3, 6, 9 and 12 months
Total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), triglycerides (TG), very low density lipoprotein cholesterol (VLDL-C), and Non-HDL-C; blood sugar;
0, 3, 6, 9 and 12 months
Serum markers regarding cytokine profile
Time Frame: 0, 3, 6, 9 and 12 months
IL-1β, IL-4, IL-6, IL-8, IL-10, IL-12(p40), IL-15, IL-17A, TNFα, TNFβ, IFN-γ, RANTES, TGFβ, lymphotactin, and C-reactive protein level (CRP)
0, 3, 6, 9 and 12 months
Serum levels of Hepatitis B and C
Time Frame: 0, 3, 6, 9 and 12 months
Serum levels of Hepatitis B and C
0, 3, 6, 9 and 12 months
tolerance and the adverse events
Time Frame: 3-year follow up

The classification for uncomfortable reaction is: 0, no discomfort; 1, slightly unwell, does not affect daily life; 2, moderate discomfort, affects daily life and work; 3, moderately unwell, significantly affects life, and bed rest; 4, severely unwell, life-threatening.

A serious adverse event is defined as fatal, life threatening, permanently disabling, and tumors, particularly hepatocellular carcinoma.
3-year follow up
Changes of any clinical symptoms
Time Frame: 3-year follow up
abdominal distension, appetite, debilitation, and edema of lower limbs.
3-year follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliancells Bioscience Corporation Limited

Investigators

  • Study Chair: Xuetao Pei, MD,PhD, Chinese Industry and Innovative Technology Strategic Alliance of Stem Cells and Regenerative Medicine
  • Study Director: Yongjun Liu, MD,PhD, Alliancells Bioscience Corporation Limited
  • Study Director: Mingyuan Wu, MD,PhD, Eastern Union Stem Cell & Gene Engineering Co.,Ltd， Alliancells Bioscience Corporation Limited
  • Principal Investigator: Hanwei Li, MD,PhD, The 302 Hospital of Chinese People's Liberation Army
  • Principal Investigator: Liming Wang, MD, The 323 Hospital of Chinese People's Liberation Army
  • Principal Investigator: Xun Li, MD,PhD, LanZhou University
  • Principal Investigator: Liming Chen, MD,PhD, ongji Hospital of Tongji University
  • Principal Investigator: Jianwei Lu, MD, Tongji Hospital
  • Principal Investigator: Hui Shi, MD, The First People's Hospital of Lianyungang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

July 1, 2015

Study Completion (Anticipated)

October 1, 2015

Study Registration Dates

First Submitted

April 6, 2012

First Submitted That Met QC Criteria

April 9, 2012

First Posted (Estimate)

April 10, 2012

Study Record Updates

Last Update Posted (Estimate)

April 14, 2015

Last Update Submitted That Met QC Criteria

April 12, 2015

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Alliancells-2012-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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