Injectable Collagen Scaffold™ Combined With HUC-MSCs Transplantation for Patients With Decompensated Cirrhosis

Chinese Academy of Sciences

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Decompensated Cirrhosis

Treatments: Biological: Injectable Collagen Scaffold + HUC-MSCs; Biological: Conventional therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02786017

CAS-XDA-DC/IGDB

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Conventional therapy

Sham Comparator group

Treatment:

Biological: Conventional therapy

Injectable Collagen Scaffold + HUC-MSCs

Experimental group

Treatment:

Biological: Injectable Collagen Scaffold + HUC-MSCs