Injectable Collagen Scaffold™ Combined With HUC-MSCs Transplantation for Patients With Decompensated Cirrhosis
NCT ID: NCT02786017
Last Updated: 2020-01-13
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
40 participants
INTERVENTIONAL
2016-05-31
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Conventional therapy
Conventional therapy
Patients will receive the conventional therapy.
Injectable Collagen Scaffold + HUC-MSCs
Injectable Collagen Scaffold + HUC-MSCs
Injectable collagen scaffold combined with HUC-MSCs was injected into left lateral segment, left medial segment, right anterior segment, right posterior segment and caudate lobe under B-mode ultrasound supervision, respectively. The total amount of HUC-MSCs was 5\*10\^8.
Interventions
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Conventional therapy
Patients will receive the conventional therapy.
Injectable Collagen Scaffold + HUC-MSCs
Injectable collagen scaffold combined with HUC-MSCs was injected into left lateral segment, left medial segment, right anterior segment, right posterior segment and caudate lobe under B-mode ultrasound supervision, respectively. The total amount of HUC-MSCs was 5\*10\^8.
Eligibility Criteria
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Inclusion 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
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.
18 Years
ALL
No
Sponsors
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Chinese Academy of Sciences
OTHER_GOV
Responsible Party
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Jianwu Dai
Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS
Principal Investigators
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Jianwu Dai, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Sciences
Locations
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CAS-XDA-DC/IGDB
Identifier Type: -
Identifier Source: org_study_id
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