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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02297867
Recruitment Status : Completed
First Posted : November 21, 2014
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Sabrina Huang, 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.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Drug: ADSCs Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adipose-Derived Stem Cells (ADSCs) Injections for Liver Cirrhosis
Actual Study Start Date : July 13, 2015
Actual Primary Completion Date : December 18, 2017
Actual Study Completion Date : March 27, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Arm Intervention/treatment
Experimental: ADSCs
One milliliter of cell suspension will be injected intrahepatically under sonographic guidance using a gauge-18 needle.
Drug: ADSCs
autologous ADSCs
Other Name: hADSCs




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02297867


Locations
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Taiwan
China Medical University Beigang Hospital
Taichung, Beigang, Taiwan, 65152
Gwo Xi Stem Cell Applied Technology Co., Ltd.
Hsinchu, Taiwan, 30261
Sponsors and Collaborators
Gwo Xi Stem Cell Applied Technology Co., Ltd.
Investigators
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Study Director: CMU B Hospital China Medical University Beigang Hospital

Publications:
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Responsible Party: Sabrina Huang, China Medical University Beigang Hospital, Gwo Xi Stem Cell Applied Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT02297867     History of Changes
Other Study ID Numbers: 28113265
First Posted: November 21, 2014    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: CRO

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases