Clinical trial NCT01342250: Human Umbilical Cord Mesenchymal Stem Cells Transplantation for Patients With Decompensated Liver Cirrhosis
Official title: Phase Ι/Π Study of Human Umbilical Cord Mesenchymal Stem Cells Transplantation for Patients With Decompensated Liver Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Liver Cirrhosis
Keywords: Decompensated Liver Cirrhosis
Umbilical Cord Mesenchymal Stem Cells
Lead sponsor: Shenzhen Beike Bio-Technology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: No.85 Hospital, Changning, Shanghai, China
First posted: 2011-04-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although liver transplantation provide a option to cure patients suffering with decompensated liver cirrhosis this condition, lack of donors, postoperative complications, especially rejection, and high cost limit its application. Bone marrow derived mesenchymal stem cells (BM-MSCs) have been shown to replace hepatocytes in injured liver, effectively rescued experimental liver failure and contributed to liver regeneration, which suggest the novel and promising therapeutic strategy In this study, the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSCs) transplantation for patients with decompensated liver cirrhosis will be evaluated.

Detailed description: To investigate the safety and efficacy of human umbilical cord mesenchymal stem cells transplantation in patients of decompensated liver cirrhosis.

Eligibility criteria: Inclusion Criteria:

* Written informed consent.
* Aged 18-70 years.
* Decompensated liver cirrhosis, Child-Pugh B/C (7-12 points); or Meld score≦21.
* Expecting lifetime is over 2 months.
* Hepatitis B decompensated liver cirrhosis patients need antiviral therapy.

Exclusion Criteria:

* Severe drug allergic history or anaphylaxis.
* Severe problems in other vital organs(e.g. the heart, renal or lungs)
* Severe problems in psychiatric disease,such as Schizophrenia,et al
* Severe bacteria infection.
* Malignancies.
* Alcoholism or drug abuse.
* Plan to have liver transplantation in 3 months.
* Pregnancy
* Candidates who are participating in other study.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: 1 year after treatment
Secondary outcomes:
measure: Liver function improvement
timeFrame: 1 year after treatment
measure: The size of liver and the width of portal venous
timeFrame: 1 year after treatment
measure: Incidence of hepatocellular carcinoma within 1 year
timeFrame: 1 year after treatment
measure: Child-Pugh score, MELD score,SF36-quality of life (SF36-QOL)
timeFrame: 1 year after treatment
measure: The clinical symptom improvement(including appetite, debilitation, abdominal distension, edema of lower limbs, et al )
timeFrame: 1 year after treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Liver Disease Research Center, the Nanjing Military Command (Shanghai 85 Hospital)
state: Shanghai
Study officials:
affiliation: No.85 Hospital, Changning, Shanghai, China
name: Chengwei Chen
role: PRINCIPAL_INVESTIGATOR
References: