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 : January 13, 2020
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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 2020 |
Estimated Study Completion Date : | December 2020 |

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. |
- 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 ]
- 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 ]
- 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.
- 30-Day Survival [ Time Frame: 30 days ]Patients surviving more than 30 days after study registration.
- 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 |
Inclusion Criteria:
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.
Exclusion Criteria:
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.

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
Contact: Zhifeng Xiao, Ph.D | 86-10-82614420 | zfxiao@genetics.ac.cn | |
Contact: Sufang Han, Ph.D | 86-10-82614420 | sufanghan22@genetics.ac.cn |
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 |
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 |
Other Study ID Numbers: |
CAS-XDA-DC/IGDB |
First Posted: | May 30, 2016 Key Record Dates |
Last Update Posted: | January 13, 2020 |
Last Verified: | April 2016 |
Liver Cirrhosis Fibrosis Pathologic Processes Liver Diseases Digestive System Diseases |