Clinical trial NCT01573923: Safety and Efficacy Study of Umbilical Mesenchymal Stem Cells for Liver Cirrhosis
Official title: Clinical Trial of Umbilical Mesenchymal Stem Cells Transplantation for Liver Cirrhosis-Phase I/II
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Liver Cirrhosis
Keywords: Umbilical Mesenchymal Stem Cells; Liver cirrhosis
Lead sponsor: Alliancells Bioscience Corporation Limited
Sponsor class: INDUSTRY
First posted: 2012-04-10
Enrollment: 320
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: survival time
timeFrame: 3-year follow up
Secondary outcomes:
measure: Serum markers regarding liver and kidney function
timeFrame: 0, 3, 6, 9 and 12 months
measure: Serum markers regarding lipid and sugar profile
timeFrame: 0, 3, 6, 9 and 12 months
measure: Serum markers regarding cytokine profile
timeFrame: 0, 3, 6, 9 and 12 months
measure: Serum levels of Hepatitis B and C
timeFrame: 0, 3, 6, 9 and 12 months
measure: tolerance and the adverse events
timeFrame: 3-year follow up
measure: Changes of any clinical symptoms
timeFrame: 3-year follow up
Other outcomes:
Locations:
city: Beijing
country: China
facility: The 302 Hospital of Chinese People's Liberation Army
state: Beijing
city: Lanzhou
country: China
facility: the First Affiliated Hospital of Lanzhou University
state: Gansu
city: Qionghai
country: China
facility: Hainan BOAO Life infinity international anti-aging medical center
state: Hainan
city: Lianyungang
country: China
facility: The first people's hospital of Lianyungang
state: Jiangsu
city: Shanghai
country: China
facility: Tongji Hospital of Tongji University
state: Shanghai
city: Xi'an
country: China
facility: The 323 Hospital of Chinese People's Liberation Army
state: Shanxi
Study officials:
affiliation: Chinese Industry and Innovative Technology Strategic Alliance of Stem Cells and Regenerative Medicine
name: Xuetao Pei, MD,PhD
role: STUDY_CHAIR
affiliation: Alliancells Bioscience Corporation Limited
name: Yongjun Liu, MD,PhD
role: STUDY_DIRECTOR
affiliation: Eastern Union Stem Cell & Gene Engineering Co.,Ltd， Alliancells Bioscience Corporation Limited
name: Mingyuan Wu, MD,PhD
role: STUDY_DIRECTOR
affiliation: The 302 Hospital of Chinese People's Liberation Army
name: Hanwei Li, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The 323 Hospital of Chinese People's Liberation Army
name: Liming Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: LanZhou University
name: Xun Li, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: ongji Hospital of Tongji University
name: Liming Chen, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tongji Hospital
name: Jianwei Lu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First People's Hospital of Lianyungang
name: Hui Shi, MD
role: PRINCIPAL_INVESTIGATOR
References: