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

Primary Purpose

Liver Cirrhosis

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
mesenchymal stem cells
Conventional therapy
Sponsored by
Alliancells Bioscience Corporation Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis focused on measuring Umbilical Mesenchymal Stem Cells; Liver cirrhosis

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The 302 Hospital of Chinese People's Liberation ArmyRecruiting
  • the First Affiliated Hospital of Lanzhou UniversityRecruiting
  • Hainan BOAO Life infinity international anti-aging medical centerRecruiting
  • The first people's hospital of LianyungangRecruiting
  • Tongji Hospital of Tongji UniversityRecruiting
  • The 323 Hospital of Chinese People's Liberation ArmyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Conventional therapy

mesenchymal stem cells

Arm Description

only apply for conventional medical therapy without any cell therapy

combination of conventional therapy with umbilical mesenchymal stem cells intravenous injection, (4x107/40ml, once per three months, four times in one year)

Outcomes

Primary Outcome Measures

survival time

Secondary Outcome Measures

Serum markers regarding liver and kidney function
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)
Serum markers regarding lipid and sugar profile
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;
Serum markers regarding cytokine profile
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)
Serum levels of Hepatitis B and C
Serum levels of Hepatitis B and C
tolerance and the adverse events
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.
Changes of any clinical symptoms
abdominal distension, appetite, debilitation, and edema of lower limbs.

Full Information

First Posted
April 6, 2012
Last Updated
April 12, 2015
Sponsor
Alliancells Bioscience Corporation Limited
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1. Study Identification

Unique Protocol Identification Number
NCT01573923
Brief Title
Safety and Efficacy Study of Umbilical Mesenchymal Stem Cells for Liver Cirrhosis
Acronym
LC
Official Title
Clinical Trial of Umbilical Mesenchymal Stem Cells Transplantation for Liver Cirrhosis-Phase I/II
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
October 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliancells Bioscience Corporation Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis
Keywords
Umbilical Mesenchymal Stem Cells; Liver cirrhosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional therapy
Arm Type
Sham Comparator
Arm Description
only apply for conventional medical therapy without any cell therapy
Arm Title
mesenchymal stem cells
Arm Type
Active Comparator
Arm Description
combination of conventional therapy with umbilical mesenchymal stem cells intravenous injection, (4x107/40ml, once per three months, four times in one year)
Intervention Type
Biological
Intervention Name(s)
mesenchymal stem cells
Intervention Description
Conventional therapy plus UC-MSC intravenous administration (4x107/40ml, once per three months, four times in one year)
Intervention Type
Biological
Intervention Name(s)
Conventional therapy
Intervention Description
Conventional therapy without cell therapy
Primary Outcome Measure Information:
Title
survival time
Time Frame
3-year follow up
Secondary Outcome Measure Information:
Title
Serum markers regarding liver and kidney function
Description
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)
Time Frame
0, 3, 6, 9 and 12 months
Title
Serum markers regarding lipid and sugar profile
Description
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;
Time Frame
0, 3, 6, 9 and 12 months
Title
Serum markers regarding cytokine profile
Description
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)
Time Frame
0, 3, 6, 9 and 12 months
Title
Serum levels of Hepatitis B and C
Description
Serum levels of Hepatitis B and C
Time Frame
0, 3, 6, 9 and 12 months
Title
tolerance and the adverse events
Description
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.
Time Frame
3-year follow up
Title
Changes of any clinical symptoms
Description
abdominal distension, appetite, debilitation, and edema of lower limbs.
Time Frame
3-year follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xuetao Pei, MD,PhD
Phone
86-10-68214650
Email
peixt@nic.bmi.ac.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Haijie Ji, MD
Phone
86-10-63188853
Email
jihaijie82@sohu.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xuetao Pei, MD,PhD
Organizational Affiliation
Chinese Industry and Innovative Technology Strategic Alliance of Stem Cells and Regenerative Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yongjun Liu, MD,PhD
Organizational Affiliation
Alliancells Bioscience Corporation Limited
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mingyuan Wu, MD,PhD
Organizational Affiliation
Eastern Union Stem Cell & Gene Engineering Co.,Ltd， Alliancells Bioscience Corporation Limited
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hanwei Li, MD,PhD
Organizational Affiliation
The 302 Hospital of Chinese People's Liberation Army
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Liming Wang, MD
Organizational Affiliation
The 323 Hospital of Chinese People's Liberation Army
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xun Li, MD,PhD
Organizational Affiliation
LanZhou University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Liming Chen, MD,PhD
Organizational Affiliation
ongji Hospital of Tongji University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jianwei Lu, MD
Organizational Affiliation
Tongji Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hui Shi, MD
Organizational Affiliation
The First People's Hospital of Lianyungang
Official's Role
Principal Investigator
Facility Information:
Facility Name
The 302 Hospital of Chinese People's Liberation Army
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanwei Li, MD, PhD
Facility Name
the First Affiliated Hospital of Lanzhou University
City
Lanzhou
State/Province
Gansu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xun Li, MD, PhD
First Name & Middle Initial & Last Name & Degree
Xun Li, MD
Facility Name
Hainan BOAO Life infinity international anti-aging medical center
City
Qionghai
State/Province
Hainan
ZIP/Postal Code
571434
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiang Shu
Email
Jiang.st@hotmail.com
Facility Name
The first people's hospital of Lianyungang
City
Lianyungang
State/Province
Jiangsu
ZIP/Postal Code
222002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Shi, MD
First Name & Middle Initial & Last Name & Degree
Hui Shi, MD
Facility Name
Tongji Hospital of Tongji University
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liming Chen, MD, PhD
First Name & Middle Initial & Last Name & Degree
Jianwei Lu, PhD
Facility Name
The 323 Hospital of Chinese People's Liberation Army
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710054
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liming Wang, MD
Phone
86-29-84756502
Email
wanglm@fmmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Liming Wang, MD

12. IPD Sharing Statement

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

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