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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.

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: GXHPC1 Phase 2

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)
Estimated Enrollment : 20 participants
Allocation: N/A
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 : February 27, 2020
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GXHPC1
One milliliter of cell suspension will be injected intrahepatically under sonographic guidance using a gauge-18 needle.
Drug: GXHPC1
autologous ADSCs
Other Name: hADSCs




Primary Outcome Measures :
  1. Neurological function [ Time Frame: 6 month ]
    The net change on NIHSS at each evaluation time point



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT04088058


Contacts
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Contact: Huang Pi Chun +886-3-6585959 ext 332 Sabrina@gwoxi.com

Locations
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Taiwan
HualienTzu Chi Hospital Recruiting
Hualien City, Taiwan, 700
Contact: Lee Mi Che, Directer         
National Taiwan University Hospital Recruiting
Taipei county, Taiwan, 10048
Contact: Huang Ka Wen, Director         
Sponsors and Collaborators
Gwo Xi Stem Cell Applied Technology Co., Ltd.
Investigators
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Principal Investigator: Huang ka Wen, Director National Taiwan University Hospital
Principal Investigator: Lee Mi Che, Director Hualien Tzu Chi General Hospital
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Responsible Party: Gwo Xi Stem Cell Applied Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT04088058    
Other Study ID Numbers: GXHPC1
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: March 5, 2020
Last Verified: March 2020

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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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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases