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

Decompensated Cirrhosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02786017
• Other study ID #: CAS-XDA-DC/IGDB
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 2016
• Est. completion date: December 2020

Study information

• Verified date: April 2016
• Source: Chinese Academy of Sciences
• Contact: Zhifeng Xiao, Ph.D
• Phone: 86-10-82614420
• Email: zfxiao[@]genetics.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Decompensated Cirrhosis
• Fibrosis
• Liver Cirrhosis

Intervention

Biological:
• Conventional therapy
Patients will receive the conventional therapy.
• 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.

Locations

Country	Name	City	State
China	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Chinese Academy of Sciences	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Improvement of liver function measured by change in Child-Pugh score		1 week, 2 week, 1, 3, 6, 12, 24 month after intervention
Secondary	Change in clinical laboratory parameters of liver function	The liver function tests included serum Albumin (Alb), Cholesterol, Cholinesterase (CHE), prothrombin activity.	1 day, 3 day, 1 week, 2 week, 1, 3, 6, 12, 24 month after intervention
Secondary	30-Day Survival	Patients surviving more than 30 days after study registration.	30 days
Secondary	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