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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03863002
Other study ID # Tianjin Weikai Bioeng., Ltd
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date October 1, 2019
Est. completion date October 1, 2022

Study information

Verified date April 2018
Source Tianjin Weikai Bioeng., Ltd.
Contact Xiuli Cong, MD, PhD
Phone +86 18512507567
Email cong_xiuli@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Safety and Efficacy of Mesenchymal Stem Cell Transplantation for Acute-on-Chronic Liver Failure


Description:

Acute-on-chronic liver failure (ACLF) which occurs in patients with chronic liver disease, is a serious live-threatening disease. Currently, the clinical management, such as liver protection, anti-virus medicine, and artificial liver support, has not significantly improve the outcomes, the mortality still remains over 50%. Liver transplantation is the only effective treatment of ACLF, but this therapy is limited by the shortage of donor organs, potential surgical complications, immunological rejection and high medical costs. Mesenchymal stem cell (MSC) is one of adult stem cells, which has been suggested to play a role in amelioration of liver disease, such as: trans-differentiation of MSCs into hepatocytes, immunomodulation, inhibition of fibrosis development, protective effects on hepatic cell and restoration of hepatic cell proliferation capacity.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 45
Est. completion date October 1, 2022
Est. primary completion date October 1, 2021
Accepts healthy volunteers No
Gender All
Age group 16 Years to 60 Years
Eligibility Inclusion Criteria:

1. Informed consent

2. Meeting the definition of ACLF: patients with previously diagnosed or undiagnosed chronic liver disease acute decompensated within 4 weeks; significant GI symptom as such fatigue, jaundice; serum total bilirubin [TBil] =10 X the upper limit of normal; coagulopathy (international normalized ratio [INR] =1.5 or prothrombin activity [PTA] <40%); complicated within 4 weeks by ascites and/or encephalopathy as determined by physical examination.

3. Model for End-Stage Liver Disease (MELD) scores ranging 17-30, (MELD(i) = 0.957 × ln(Cr) + 0.378 × ln(bilirubin) + 1.120 × ln(INR) + 0.643);

4. Chronic liver disease with definitive etiology such as viral hepatitis, alcohol liver disease, drug induced liver injury or autoimmune liver diseases

5. Body weight =50kg

Exclusion Criteria:

1. Serious complications in the previous 2 months (e.g., gastrointestinal bleeding: hemoglobin below 90g/L, serious infection such as sepsis, ascites ultrafiltration, and/or dialysis);

2. Malignant jaundice induced by obstructive jaundice or hemolytic jaundice;

3. Hepatocellular carcinoma (HCC) diagnosed by radiologic imaging and/or alpha fetoprotein (AFP);

4. Tumor diagnosed by ultrasound, CT, MR examination;

5. Moderate or severe chronic heart failure (NYHA III-IV), renal replacement therapy, severe chronic pulmonary disease (GOLD III-IV)

6. Extrahepatic cholestasis

7. Hepatic, portal and splenic vein thrombosis diagnosed by doppler ultrasound

8. Artificial liver support

9. Previous liver transplantation

10. Drug abuse in the past 5 years;

11. Mental disorders and/or has a family history of mental disorder.

12. HIV infection

13. Pregnant or breast-feeding females

14. Highly allergic

15. Patients can not cooperate or mobility

16. Enrolled in other clinical trials with 3 months

17. Patients who can not provide prior informed consent or refusal to participate

Study Design


Intervention

Biological:
Mesenchymal Stem Cell
Mesenchymal stem cell transplantation via peripheral vein: 1.0-10x10^5 MSCs/kg body weight administered via peripheral vein at week 0, 1, 2, 3 weeks

Locations

Country Name City State
China Tianjin Weikai Bioeng., Ltd. Tianjin Tianjin

Sponsors (2)

Lead Sponsor Collaborator
Tianjin Weikai Bioeng., Ltd. Tianjin Nankai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary survival rate Number of participants alive 72 weeks after treatment
Secondary Adverse reactions Number of participants with adverse reactions (e.g. fever, rash, and diarrhea ) Week 1, 2, 4, 8, 12, 24, 36, 48
Secondary White blood cell Change of white blood cell count Week 1, 2, 4, 8, 12, 24, 36, 48
Secondary Platelet Change of platelet count Week 1, 2, 4, 8, 12, 24, 36, 48
Secondary Hemoglobin Change of hemoglobin level Week 1, 2, 4, 8, 12, 24, 36, 48
Secondary Creatinine Change of creatinine level as a surrogate marker of liver function Week 1, 2, 4, 8, 12, 24, 36, 48
Secondary ALT Change of alanine aminotransferase (ALT) level as a marker of liver function Week 1, 2, 4, 8, 12, 24, 36, 48
Secondary ALB Change of albumin (ALB) level as a maker of liver function Week 1, 2, 4, 8, 12, 24, 36, 48
Secondary TBil Change of total Bilirubin (TBil) level as a marker of liver function Week 1, 2, 4, 8, 12, 24, 36, 48
Secondary INRs Change of international normalized ratio (INRs) level as a marker of liver function Week 1, 2, 4, 8, 12, 24, 36, 48
Secondary AFP Change of alpha fetoprotein (AFP) level as a marker of liver function Week 1, 2, 4, 8, 12, 24, 36, 48
Secondary MELD scores Model for End-Stage Liver Disease (MELD) score for assessing the severity of chronic liver disease is measured as absolute change to baseline score Week 1, 2, 4, 8, 12, 24, 36, 48
Secondary Tumor formation Number of participants with hepatocellular carcinoma or extrahepatic malignant tumors Week 1, 2, 4, 8, 12, 24, 36, 48
Secondary Liver failure-associated serious complications Number of participants with liver failure-associated serious complications, such as infections, encephalopathy, gastrointestinal bleeding and HRS Week 1, 2, 4, 8, 12, 24, 36, 48
See also
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