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

Liver Cirrhosis Clinical Trial

Official title:

Adipose-Derived Stem Cells (ADSCs) Injections for Liver Cirrhosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02297867
• Other study ID #: 28113265
• Status: Completed
• Phase: Phase 1
• First received: November 19, 2014
• Last updated: April 15, 2018
• Start date: July 13, 2015
• Est. completion date: March 27, 2018

Study information

• Verified date: July 2017
• Source: Gwo Xi Stem Cell Applied Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: March 27, 2018
• Est. primary completion date: December 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis

Intervention

Drug:
• ADSCs
autologous ADSCs

Locations

Country	Name	City	State
Taiwan	Gwo Xi Stem Cell Applied Technology Co., Ltd.	Hsinchu
Taiwan	China Medical University Beigang Hospital	Taichung	Beigang

Sponsors (1)

Lead Sponsor	Collaborator
Gwo Xi Stem Cell Applied Technology Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Harn HJ, Lin SZ, Hung SH, Subeq YM, Li YS, Syu WS, Ding DC, Lee RP, Hsieh DK, Lin PC, Chiou TW. Adipose-derived stem cells can abrogate chemical-induced liver fibrosis and facilitate recovery of liver function. Cell Transplant. 2012;21(12):2753-64. doi: 10.3727/096368912X652959. Epub 2012 Jul 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MELD	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.	1-6 month