Safety and Efficacy Study of Umbilical Mesenchymal Stem Cells for Liver Cirrhosis
NCT ID: NCT01573923
Last Updated: 2015-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
320 participants
INTERVENTIONAL
2014-07-31
2015-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conventional therapy
only apply for conventional medical therapy without any cell therapy
Conventional therapy
Conventional therapy without cell therapy
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)
mesenchymal stem cells
Conventional therapy plus UC-MSC intravenous administration (4x107/40ml, once per three months, four times in one year)
Interventions
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mesenchymal stem cells
Conventional therapy plus UC-MSC intravenous administration (4x107/40ml, once per three months, four times in one year)
Conventional therapy
Conventional therapy without cell therapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
60 Years
ALL
No
Sponsors
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Alliancells Bioscience Corporation Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Xuetao Pei, MD,PhD
Role: STUDY_CHAIR
Chinese Industry and Innovative Technology Strategic Alliance of Stem Cells and Regenerative Medicine
Yongjun Liu, MD,PhD
Role: STUDY_DIRECTOR
Alliancells Bioscience Corporation Limited
Mingyuan Wu, MD,PhD
Role: STUDY_DIRECTOR
Eastern Union Stem Cell & Gene Engineering Co.,Ltd， Alliancells Bioscience Corporation Limited
Hanwei Li, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
The 302 Hospital of Chinese People's Liberation Army
Liming Wang, MD
Role: PRINCIPAL_INVESTIGATOR
The 323 Hospital of Chinese People's Liberation Army
Xun Li, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
LanZhou University
Liming Chen, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
ongji Hospital of Tongji University
Jianwei Lu, MD
Role: PRINCIPAL_INVESTIGATOR
Tongji Hospital
Hui Shi, MD
Role: PRINCIPAL_INVESTIGATOR
The First People's Hospital of Lianyungang
Locations
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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, China
The first people's hospital of Lianyungang
Lianyungang, Jiangsu, China
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality, China
The 323 Hospital of Chinese People's Liberation Army
Xi’an, Shanxi, China
Countries
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Central Contacts
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Facility Contacts
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Xun Li, MD, PhD
Role: primary
Hui Shi, MD
Role: primary
Liming Chen, MD, PhD
Role: primary
Other Identifiers
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Alliancells-2012-1
Identifier Type: -
Identifier Source: org_study_id
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