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A Phase II Open-label Single-arm Study to Evaluate the Efficacy and Safety of ADSCs in Subjects With 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: NCT04088058
Recruitment Status : Unknown
Verified March 2020 by Gwo Xi Stem Cell Applied Technology Co., Ltd..
Recruitment status was:  Recruiting
First Posted : September 12, 2019
Last Update Posted : March 5, 2020
Sponsor:
Information provided by (Responsible Party):
Gwo Xi Stem Cell Applied Technology Co., Ltd.

Tracking Information
First Submitted Date  ICMJE September 11, 2019
First Posted Date  ICMJE September 12, 2019
Last Update Posted Date March 5, 2020
Actual Study Start Date  ICMJE February 27, 2020
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2019)
Neurological function [ Time Frame: 6 month ]
The net change on NIHSS at each evaluation time point
Original Primary Outcome Measures  ICMJE
 (submitted: September 11, 2019)
MELD [ Time Frame: 1-12 month ]
MELD uses the patient's values for serum bilirubin, serum creatinine, and the international
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase II Open-label Single-arm Study to Evaluate the Efficacy and Safety of ADSCs in Subjects With Liver Cirrhosis
Official Title  ICMJE Adipose-Derived Stem Cells (ADSCs) Injections for Liver Cirrhosis
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Liver Cirrhosis
Intervention  ICMJE Drug: GXHPC1
autologous ADSCs
Other Name: hADSCs
Study Arms  ICMJE Experimental: GXHPC1
One milliliter of cell suspension will be injected intrahepatically under sonographic guidance using a gauge-18 needle.
Intervention: Drug: GXHPC1
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 11, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2022
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Of either gender aged 20 to 70 years old (inclusive)
  2. Diagnosed liver cirrhosis by imaging, irrespective of etiology
  3. With MELD score 10 to 20 (inclusive) and Child-Pugh score 7 to 9 Note: MELD = Model For End-Stage Liver Disease
  4. Subject with alcoholic cirrhosis should have been alcohol-abstinent for at least 6 months judged by psychiatrist with records for each month and willing to continue up to the completion of study.
  5. Subject with cirrhosis caused by hepatitis B virus (HBV) should be with HBV DNA < 2,000 IU/mL before enrollment.

    Note: HBV = hepatitis B virus, DNA = deoxyribonucleic acid. IU = International unit

  6. Subject with cirrhosis caused by hepatitis C virus (HCV) should have successfully completed treatment for HCV with HCV viral load in the blood undetectable for at least 24 weeks since treatment cessation and with ALT within normal range.
  7. Provision of signed and dated informed consent form

Exclusion Criteria:

  1. With inadequate coagulation function, as defined by: INR ≥ 1.5, aPTT ≥ 54.0 seconds, platelet count ≤ 60,000/mm3.

    Note: INR = international normalized ratio, aPTT = activated partial thromboplastin time

  2. With evidence of active autoimmune disease
  3. With a medical record of solid tumor within 5 years prior to screening, or diagnosed with solid tumor and currently receiving cancer treatment
  4. With BMI ≤ 15 kg/m2 Note: BMI = body mass index
  5. With inadequate hepatic function, as defined by: total bilirubin level > 3.0 mg/dL; AST > 92.5 U/L, ALT > 112.5 U/L; gamma-GT > 212.5 U/L, or ALP > 340 U/L.

    Note: gamma-GT = gamma glutamyl transpeptidase

  6. With inadequate renal function, as defined by serum creatinine > 2.0 mg/dL
  7. The subject refuses to adopt highly effective contraceptives from signing informed consent to Final visit if female subject or female spouse/partner of male subject is of childbearing potential

    Note: At least two forms of birth control must be adopted and one of which must be a barrier method. Acceptable forms of birth control include:

    1. Established use of oral, injected or implanted hormonal methods of contraception
    2. Placement of an intrauterine device (IUD) or intrauterine system (IUS)
    3. Barrier methods of contraception: condom OR occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
  8. Female subject with childbearing potential who is pregnant (confirmed by urine or serum pregnancy test) or lactating
  9. Having participated other investigational study within 4 weeks of entering this study
  10. Has a known allergy to study intervention or its excipients. If there is suspicion that the subject may have an allergy, the subject should be excluded.
  11. With ongoing infection requiring systemic treatment such as HIV, syphilis or acute infectious disease except HBV or HCV Note: HIV = human immunodeficiency virus
  12. With drug dependency for the past 1 year of Screening visit
  13. With any rare diseases
  14. With uncontrolled hypertension (≥180/≥110 mmHg on more than 2 antihypertensive medications) or uncontrolled diabetic mellitus (HbA1c > 9.0%)
  15. With liver abscess or moderate to severe (or refractory) ascites
  16. With uncontrolled psychiatric disorder or altered mental status precluding informed consent or necessary testing
  17. Having received major surgery within past 12 weeks of Screening visit Note: Major surgery means an operation upon an organ within the cranium, chest, abdomen, or pelvic cavity
  18. With acute stroke within past 4 weeks of Screening visit and being unclear consciousness
  19. With acute myocardial infarction or acute heart failure
  20. Has uncontrolled ongoing illness or medical history considered by the investigator not in the condition to enter the trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04088058
Other Study ID Numbers  ICMJE GXHPC1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Gwo Xi Stem Cell Applied Technology Co., Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Gwo Xi Stem Cell Applied Technology Co., Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Huang ka Wen, Director National Taiwan University Hospital
Principal Investigator: Lee Mi Che, Director Hualien Tzu Chi General Hospital
PRS Account Gwo Xi Stem Cell Applied Technology Co., Ltd.
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP