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

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ClinicalTrials.gov Identifier: NCT02786017
Recruitment Status : Unknown
Verified April 2016 by Jianwu Dai, Chinese Academy of Sciences.
Recruitment status was:  Recruiting
First Posted : May 30, 2016
Last Update Posted : May 30, 2016
Sponsor:
Collaborator:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Information provided by (Responsible Party):
Jianwu Dai, Chinese Academy of Sciences

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.

Condition or disease Intervention/treatment Phase
Decompensated Cirrhosis Biological: Conventional therapy Biological: Injectable Collagen Scaffold + HUC-MSCs Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : May 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis
Drug Information available for: Collagen

Arm Intervention/treatment
Sham Comparator: Conventional therapy Biological: Conventional therapy
Patients will receive the conventional therapy.

Experimental: Injectable Collagen Scaffold + HUC-MSCs Biological: 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.




Primary Outcome Measures :
  1. Improvement of liver function measured by change in the model for end-stage liver disease (MELD) score [ Time Frame: 1 week, 2 week, 1, 3, 6, 12, 24 month after intervention ]

Secondary Outcome Measures :
  1. Improvement of liver function measured by change in Child-Pugh score [ Time Frame: 1 week, 2 week, 1, 3, 6, 12, 24 month after intervention ]
  2. Change in clinical laboratory parameters of liver function [ Time Frame: 1 day, 3 day, 1 week, 2 week, 1, 3, 6, 12, 24 month after intervention ]
    The liver function tests included serum Albumin (Alb), Cholesterol, Cholinesterase (CHE), prothrombin activity.

  3. 30-Day Survival [ Time Frame: 30 days ]
    Patients surviving more than 30 days after study registration.

  4. Change in the size of liver and spleen and inner diameter of spleen portal venous [ Time Frame: 1 week, 2 week, 1, 3, 6, 12, 24 month after intervention ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786017


Contacts
Contact: Zhifeng Xiao, Ph.D 86-10-82614420 zfxiao@genetics.ac.cn
Contact: Sufang Han, Ph.D 86-10-82614420 sufanghan22@genetics.ac.cn

Locations
China, Jiangsu
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Recruiting
Nanjing, Jiangsu, China, 210008
Contact: Xiaolei Shi, M.D.    86-25-83304616 ext 11901    njsxl2000@163.com   
Sponsors and Collaborators
Chinese Academy of Sciences
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Investigators
Principal Investigator: Jianwu Dai, Ph.D Chinese Academy of Sciences

Responsible Party: Jianwu Dai, Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS, Chinese Academy of Sciences
ClinicalTrials.gov Identifier: NCT02786017     History of Changes
Other Study ID Numbers: CAS-XDA-DC/IGDB
First Posted: May 30, 2016    Key Record Dates
Last Update Posted: May 30, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases