Adipose-Derived Stem Cells (ADSCs) Injections for Liver Cirrhosis
Overview
- Phase
- Phase 1
- Intervention
- ADSCs
- Conditions
- Liver Cirrhosis
- Sponsor
- Gwo Xi Stem Cell Applied Technology Co., Ltd.
- Enrollment
- 6
- Locations
- 2
- Primary Endpoint
- MELD
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Sabrina Huang
China Medical University Beigang Hospital
Gwo Xi Stem Cell Applied Technology Co., Ltd.
Eligibility Criteria
Inclusion Criteria
- •Liver cirrhosis investigators with age 20 to 80 years (both inclusive).
- •Investigators without Mandatory Communicable Disease (HBV, HCV, HIV, syphilis)
- •Investigators without rare disorder
- •Coagulation normalities
- •Investigators without autoimmune disorder
- •Investigators without Acquired Immune Deficiency Syndrome
- •Investigators without cancer
- •Investigators BMI \> 15
Exclusion Criteria
- •Pregnant women
- •Investigators with acute stroke in one month and unconsciousness
- •Investigators with acute myocardial infarction or acute heart failure
- •Investigators with serious liver dysfunction and coagulation dysfunction and ascites mild higher
- •Investigators with acute respiratory failure or pneumonia
- •Kidney Failure: BUN \> 50
- •Anemia: Hematocrit \< 25
- •Investigators diagnosed with liver cancer or liver metastatic carcinoma
- •Investigators with liver abscess
- •Investigators with acute Hepatitis
Arms & Interventions
ADSCs
One milliliter of cell suspension will be injected intrahepatically under sonographic guidance using a gauge-18 needle.
Intervention: ADSCs
Outcomes
Primary Outcomes
MELD
Time Frame: 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.