Clinical trial NCT02786017: Injectable Collagen Scaffold™ Combined With HUC-MSCs Transplantation for Patients With Decompensated Cirrhosis
Official title: The Safety and Efficacy Assessment of Injectable Collagen Scaffold™ Combined With Human Umbilical Cord-derived Mesenchymal Stem Cells (HUC-MSCs) Transplantation in Patients With Decompensated Cirrhosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Decompensated Cirrhosis
Lead sponsor: Chinese Academy of Sciences
Sponsor class: OTHER_GOV
Collaborators: name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
First posted: 2016-05-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of injectable collagen scaffold combined with human umbilical cord-derived mesenchymal stem cells (HUC-MSCs) transplantation in patients with Decompensated Cirrhosis.


Eligibility criteria: Inclusion Criteria:

Participants must meet all of the following criteria:

1. Subjects who are decompensated cirrhosis of any cause.
2. Subjects are repeated exacerbations despite treatment and hospitalized more than once within one year because of complications of cirrhosis, (e.g., massive ascites, spontaneous bacterial peritonitis, gastrointestinal bleeding or hepatic encephalopathy).
3. Need intermittent plasma albumin and oral diuretics supplement.
4. Serum albumin \<35 g/L, total bilirubin\<170 μmol/L, prothrombin activity \>30% (prothrombin time \<20 s), moderate or mild ascites, spontaneous bacterial peritonitis and hepatic encephalopathy have been cured, Child-pugh score ≥7.
5. Peripheral blood hemoglobin concentration\> 70g/L，platelet count \> 3 × 10\^9/L, hematocrit (HCT) level\>0.25.
6. No gastrointestinal bleeding during the last one month before enrolment.
7. Patient has no conditional to undergo orthotopic liver transplantation (OLT).
8. Willing to sign informed consent.

Exclusion Criteria:

Participants CANNOT meet any of the following criteria:

1. The presence of hepatocellular carcinoma (HCC) or other malignant tumors.
2. Complicated with gastrointestinal bleeding, spontaneous bacterial peritonitis, hepatic encephalopathy, hepatorenal syndrome and acute exacerbation of infection.
3. Presence of severe comorbid diseases (e.g., severe renal, respiratory, cardiac or blood disease).
4. Pregnant or lactating women.
5. Allergy to G-CSF, contrast agents and anticoagulants.
6. Alcoholism or drug abuse.

Primary outcomes:
measure: Improvement of liver function measured by change in the model for end-stage liver disease (MELD) score
timeFrame: 1 week, 2 week, 1, 3, 6, 12, 24 month after intervention
Secondary outcomes:
measure: Improvement of liver function measured by change in Child-Pugh score
timeFrame: 1 week, 2 week, 1, 3, 6, 12, 24 month after intervention
measure: Change in clinical laboratory parameters of liver function
timeFrame: 1 day, 3 day, 1 week, 2 week, 1, 3, 6, 12, 24 month after intervention
measure: 30-Day Survival
timeFrame: 30 days
measure: Change in the size of liver and spleen and inner diameter of spleen portal venous
timeFrame: 1 week, 2 week, 1, 3, 6, 12, 24 month after intervention
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
state: Jiangsu
Study officials:
affiliation: Chinese Academy of Sciences
name: Jianwu Dai, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: