Clinical Trial Study About Human Adipose-Derived Stem Cells in the Liver Cirrhosis

Phase 1

Completed

• Conditions: Liver Cirrhosis
• Interventions: Drug: ADSCs

• Registration Number: NCT02297867
• Lead Sponsor: Gwo Xi Stem Cell Applied Technology Co., Ltd.

Brief Summary

The aim of the investigators study was to investigate the safety and efficacy of autologous ADSCs for the clinical treatment of liver cirrhosis.

Detailed Description

One milliliter of cell suspension will be injected intrahepatically under sonographic guidance using a gauge-18 needle.

Study Timeline

• Study First Submitted: 2014-11-19
• Study First Submitted QC: 2014-11-20
• Study First Posted: 2014-11-21
• Study Start: 2015-07-13
• Status Verified: 2017-07
• Primary Completion: 2017-12-18
• Study Completion: 2018-03-27
• Last Update Submitted: 2018-04-15
• Last Update Posted: 2018-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

1. Liver cirrhosis investigators with age 20 to 80 years (both inclusive).
2. Investigators without Mandatory Communicable Disease (HBV, HCV, HIV, syphilis)
3. Investigators without rare disorder
4. Coagulation normalities
5. Investigators without autoimmune disorder
6. Investigators without Acquired Immune Deficiency Syndrome
7. Investigators without cancer
8. Investigators BMI > 15

Exclusion Criteria

1. Pregnant women
2. Investigators with acute stroke in one month and unconsciousness
3. Investigators with acute myocardial infarction or acute heart failure
4. Investigators with serious liver dysfunction and coagulation dysfunction and ascites mild higher
5. Investigators with acute respiratory failure or pneumonia
6. Kidney Failure: BUN > 50
7. Anemia: Hematocrit < 25
8. Investigators diagnosed with liver cancer or liver metastatic carcinoma
9. Investigators with liver abscess
10. Investigators with acute Hepatitis
11. Investigators with acute infective
12. Liver cirrhosis patients with HBV or HCV
13. Investigators diagnosed with carcinoma and receiving treatment
14. Investigators with Schizophrenia or melancholia
15. Investigators received serious surgical operations in 3 months
16. Investigators unable to control hypertension (SBP > 180 mmHg, DBP > 110 mmHg) or diabetes (AC sugar > 200 mg/dl)
17. Others can't fit into the trial evaluate by investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ADSCs	ADSCs	One milliliter of cell suspension will be injected intrahepatically under sonographic guidance using a gauge-18 needle.

Primary Outcome Measures

Name	Time	Method
MELD	1-6 month	MELD uses the patient's values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival. It is calculated according to the following formula:MELD = 3.78\[Ln serum bilirubin (mg/dL)\] + 11.2\[Ln INR\] + 9.57\[Ln serum creatinine (mg/dL)\] + 6.43.

Trial Locations

Locations (2)

China Medical University Beigang Hospital; 🇨🇳 Taichung, Beigang, Taiwan

Gwo Xi Stem Cell Applied Technology Co., Ltd.; 🇨🇳 Hsinchu, Taiwan