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

NCT02786017 | Unknown Phase 1 DMC

• 1 other identifier: CAS-XDA-DC/IGDB
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Decompensated Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Improvement of liver function measured by change in the model for end-stage liver disease (MELD) score

  1 week, 2 week, 1, 3, 6, 12, 24 month after intervention

Secondary Outcomes (4)

• Improvement of liver function measured by change in Child-Pugh score

  1 week, 2 week, 1, 3, 6, 12, 24 month after intervention

• Change in clinical laboratory parameters of liver function

  1 day, 3 day, 1 week, 2 week, 1, 3, 6, 12, 24 month after intervention

• 30-Day Survival

  30 days

• Change in the size of liver and spleen and inner diameter of spleen portal venous

  1 week, 2 week, 1, 3, 6, 12, 24 month after intervention

Study Arms (2)

Conventional therapy

SHAM COMPARATOR

Biological: Conventional therapy

Injectable Collagen Scaffold + HUC-MSCs

EXPERIMENTAL

Biological: Injectable Collagen Scaffold + HUC-MSCs

Interventions

Conventional therapy BIOLOGICAL

Patients will receive the conventional therapy.

Conventional therapy

Injectable Collagen Scaffold + HUC-MSCs BIOLOGICAL

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.

Injectable Collagen Scaffold + HUC-MSCs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet all of the following criteria:
• Subjects who are decompensated cirrhosis of any cause.
• 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).
• Need intermittent plasma albumin and oral diuretics supplement.
• 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.
• Peripheral blood hemoglobin concentration\> 70g/L，platelet count \> 3 × 10\^9/L, hematocrit (HCT) level\>0.25.
• No gastrointestinal bleeding during the last one month before enrolment.
• Patient has no conditional to undergo orthotopic liver transplantation (OLT).
• Willing to sign informed consent.

You may not qualify if:

• Participants CANNOT meet any of the following criteria:
• The presence of hepatocellular carcinoma (HCC) or other malignant tumors.
• Complicated with gastrointestinal bleeding, spontaneous bacterial peritonitis, hepatic encephalopathy, hepatorenal syndrome and acute exacerbation of infection.
• Presence of severe comorbid diseases (e.g., severe renal, respiratory, cardiac or blood disease).
• Pregnant or lactating women.
• Allergy to G-CSF, contrast agents and anticoagulants.
• Alcoholism or drug abuse.

Sponsors & Collaborators

• Chinese Academy of Sciences: lead
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator

Study Sites (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

RECRUITING

Study Officials

• Jianwu Dai, Ph.D

  Chinese Academy of Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhifeng Xiao, Ph.D

CONTACT

86-10-82614420; zfxiao@genetics.ac.cn

Sufang Han, Ph.D

CONTACT

86-10-82614420; sufanghan22@genetics.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS

Study Record Dates

• First Submitted: May 25, 2016
• First Posted: May 30, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 13, 2020

Record last verified: 2016-04

Locations

CN (1)