Safety and Efficacy Study of Umbilical Mesenchymal Stem Cells for Liver Cirrhosis
LC
Clinical Trial of Umbilical Mesenchymal Stem Cells Transplantation for Liver Cirrhosis-Phase I/II
1 other identifier
interventional
320
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2014
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2012
CompletedFirst Posted
Study publicly available on registry
April 10, 2012
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedApril 14, 2015
April 1, 2012
1 year
April 6, 2012
April 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
survival time
3-year follow up
Secondary Outcomes (6)
Serum markers regarding liver and kidney function
0, 3, 6, 9 and 12 months
Serum markers regarding lipid and sugar profile
0, 3, 6, 9 and 12 months
Serum markers regarding cytokine profile
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
3-year follow up
- +1 more secondary outcomes
Study Arms (2)
Conventional therapy
SHAM COMPARATORonly apply for conventional medical therapy without any cell therapy
mesenchymal stem cells
ACTIVE COMPARATORcombination of conventional therapy with umbilical mesenchymal stem cells intravenous injection, (4x107/40ml, once per three months, four times in one year)
Interventions
Conventional therapy plus UC-MSC intravenous administration (4x107/40ml, once per three months, four times in one year)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
The 302 Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality, China
the First Affiliated Hospital of Lanzhou University
Lanzhou, Gansu, China
Hainan BOAO Life infinity international anti-aging medical center
Qionghai, Hainan, 571434, China
The first people's hospital of Lianyungang
Lianyungang, Jiangsu, 222002, China
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality, China
The 323 Hospital of Chinese People's Liberation Army
Xi’an, Shanxi, 710054, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2012
First Posted
April 10, 2012
Study Start
July 1, 2014
Primary Completion
July 1, 2015
Study Completion
October 1, 2015
Last Updated
April 14, 2015
Record last verified: 2012-04