hUC Mesenchymal Stem Cells (19#iSCLife®-LC) in the Treatment of Decompensated Hepatitis b Cirrhosishepatitis b Cirrhosis

Hepatitis B Clinical Trial

Official title:

Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-LC) in the Treatment of Decompensated Hepatitis b Cirrhosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03826433
• Other study ID #: SCLnow-XY-04
• Status: Recruiting
• Phase: Phase 1
• Start date: October 1, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Sclnow Biotechnology Co., Ltd.
• Contact: Lei Guo, doctor
• Phone: 861064368977
• Email: georgeguo[@]sclnow.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

1. Evaluation the safety of using human umbilical mesenchymal stem cells to treat patients with hepatitis B cirrhosis.

2. Observe the curative effect of patients with hepatitis B cirrhosis who use human umbilical mesenchymal stem cells to treat.

3. Explore the possible mechanism of human umbilical mesenchymal stem cells to treat patients with hepatitis B cirrhosis.

Description:

This experimental use umbilical cord mesenchymal stem cells in treatment of decompensated hepatitis B cirrhosis to evaluate its safety and efficacy,

This experimental is mainly aimed at people aged 18-60 years old, regardless of gender and with body mass index (BMI) between 19-25kg/m2 (including boundary value). It was decided into treatment group and control group to evaluate the effectiveness and safety of mesenchymal stem cells by peripheral intravenous injection.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age 18-60 years old, gender not limited, body mass index (BMI) between 19-25 kg/m2, including boundary value;

• The diagnosis of hepatitis B cirrhosis was in line with the 2015 American society of hepatology (AASLD) guidelines for the treatment of chronic hepatitis B, and the liver function grade was child-pugh B or child-pugh C, with a score range of 7-12 points, and Model for End-Stage Liver Disease score=21 points.

• Have not received stem cell therapy in the recent 6 months;

• Subjects will be able to sign the informed consent in accordance with the study procedures and instructions.

Exclusion Criteria:

• Insufficiency of vital organs, such as heart, kidney and lung;

• End-stage cirrhosis with severe complications, including but not limited to: hepatic encephalopathy, gastrointestinal bleeding,Severe bleeding tendency, massive ascites, etc.

• Concomitant peritonitis, pneumonia, or other types of infection not under control;

• Have a history of severe allergic reaction or allergy to two or more kinds of food or medicine;

• Positive serum HIV antibody and syphilis antibody;

• Alpha fetoprotein>400ng/mL with primary liver cancer or without imaging evidence;

• Chronic liver disease and cirrhosis are caused by non-chronic hepatitis B virus infection, or other factors except chronic hepatitis B virus infection ;

• Patients with severe mental illness and cognitive impairment;

Related Conditions & MeSH terms

• Fibrosis
• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Biological:
• Peripheral iv
6*10^7 cells

Locations

Country	Name	City	State
China	Xiangya Hospital Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Sclnow Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Validity evaluation by detection of the coagulation function of participants	After finish the mesenchymal stem cell treatment, observe the change of Prothrombin Time and International Normalized Ratio (PT/INR) in baseline outcome measures.; The time is around 12-13 seconds, the INR in absence of anticoagulation therapy is 0.8-1.2.	12 month
Other	Imaging examination	After finish the mesenchymal stem cell treatment, observe the Computed Tomography (CT).	12 month
Other	Imaging examination	Fibro-Touch examination	12 month
Other	Safety evaluation by detecting adverse events and serious adverse events	To evaluate the changes of safety indexes before and after mesenchymal stem cell treatment	12 month
Primary	Validity evaluation by detection of the Model for end-stage Liver Disease score of participants	After finish the mesenchymal stem cell treatment, observe the change in baseline outcome measures.; 40 or more - 71.3% observed mortality 30-39 - 52.6% observed mortality 20-29 - 19.6% observed mortality 10-19 - 6.0% observed mortality <9 - 1.9% observed mortality	12 month
Secondary	Safety evaluation by detecting Blood routine	To calculate the number of hemocyte and related protein (e.g. erythrocyte, lymphocyte, and hemoglobin) after mesenchymal stem cell treatment	12 month
Secondary	Validity evaluation by detection of the child-pugh of participants	After finish the mesenchymal stem cell treatment, observe the change in baseline outcome measures.; Points Class One-year survival Two-year survival 5-6 A 100% 85% 7-9 B 80% 60% 10-15 C 45% 35%	12 month