Injectable Collagen Scaffold™ Combined With HUC-MSCs Transplantation for Patients With Decompensated Cirrhosis
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|ClinicalTrials.gov Identifier: NCT02786017|
Recruitment Status : Recruiting
First Posted : May 30, 2016
Last Update Posted : January 25, 2019
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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 2019|
|Estimated Study Completion Date :||December 2019|
|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 ]
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.Dfirstname.lastname@example.org|
|Contact: Sufang Han, Ph.Demail@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator:||Jianwu Dai, Ph.D||Chinese Academy of Sciences|