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

NCT02297867 | Completed Phase 1

• 1 other identifier: 28113265
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

ADSCs

EXPERIMENTAL

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

Drug: ADSCs

Interventions

ADSCs DRUG

autologous ADSCs

Also known as: hADSCs

ADSCs

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Investigators with acute infective
• Liver cirrhosis patients with HBV or HCV
• Investigators diagnosed with carcinoma and receiving treatment
• Investigators with Schizophrenia or melancholia
• Investigators received serious surgical operations in 3 months

Sponsors & Collaborators

• Gwo Xi Stem Cell Applied Technology Co., Ltd.: lead

Study Sites (2)

China Medical University Beigang Hospital

Taichung, Beigang, 65152, Taiwan

Location

Gwo Xi Stem Cell Applied Technology Co., Ltd.

Hsinchu, 30261, Taiwan

Location

Related 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.

  PMID: 22776464 BACKGROUND

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• CMU B Hospital

  China Medical University Beigang Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: China Medical University Beigang Hospital

Study Record Dates

• First Submitted: November 19, 2014
• First Posted: November 21, 2014
• Study Start: July 13, 2015
• Primary Completion: December 18, 2017
• Study Completion: March 27, 2018
• Last Updated: April 17, 2018

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

TW (2)