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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

Primary Purpose

Liver Cirrhosis

Status
Recruiting
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
GXHPC1
Sponsored by
Gwo Xi Stem Cell Applied Technology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • HualienTzu Chi HospitalRecruiting
  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GXHPC1

Arm Description

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

Outcomes

Primary Outcome Measures

Change from Baseline to Week 48 in The METAVIR score
The METAVIR score is a tool used to evaluate the severity of fibrosis seen on a liver biopsy sample. The METAVIR score grades the degree of fibrosis on a 5-point scale from 0 to 4 as follows: F0: No fibrosis F1: Portal fibrosis without septa F2: Portal fibrosis with few septa F3: Numerous septa without cirrhosis F4: Cirrhosis

Secondary Outcome Measures

Change from Baseline to Week 24 in The METAVIR score
The METAVIR score is a tool used to evaluate the severity of fibrosis seen on a liver biopsy sample. The METAVIR score grades the degree of fibrosis on a 5-point scale from 0 to 4 as follows: F0: No fibrosis F1: Portal fibrosis without septa F2: Portal fibrosis with few septa F3: Numerous septa without cirrhosis F4: Cirrhosis
Change from baseline to Weeks 24, and 48 in Fibroscan® score for liver elasticity
Fibroscan® is a non-invasive modality to measure elasticity of liver tissue. A fibroscan® score is a numerical result between 2-75. A 'normal' Fibroscan range tends to be between 2-7 with an average result being roughly around 5. Scarring of the liver is measured by four stages. F0 = no scarring F1 = mild fibrosis F2 = moderate fibrosis F3 = severe fibrosis F4 = cirrhosis or advanced fibrosis
Change from baseline to Weeks 12, 24, 36, and 48 in the MELD score
The Model for End-Stage Liver Disease, or MELD, is a scoring system for assessing the severity of the chronic liver disease. MELD score is calculated according to the subject's values for serum total bilirubin, serum creatinine, and INR.
Change from baseline to Weeks 12, 24, 36, and 48 in the Child-Pugh score
The Child-Pugh score is used to assess the prognosis of chronic liver disease, mainly cirrhosis. The score employs five clinical measures of liver disease. Each measure is scored 1-3, with 3 indicating most severe derangement.
Incidence of adverse event(AE) and SAE
An adverse event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not relate with the medicinal (investigational) product.
Incidence of serious adverse event (SAE)
An adverse event (AE) or suspected adverse reaction is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes (based on ICH GCP): results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect

Full Information

First Posted
September 11, 2019
Last Updated
April 6, 2023
Sponsor
Gwo Xi Stem Cell Applied Technology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04088058
Brief Title
A Phase II Open-label Single-arm Study to Evaluate the Efficacy and Safety of ADSCs in Subjects With Liver Cirrhosis
Official Title
Adipose-Derived Stem Cells (ADSCs) Injections for Liver Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2019 (Actual)
Primary Completion Date
April 19, 2025 (Anticipated)
Study Completion Date
April 19, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gwo Xi Stem Cell Applied Technology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GXHPC1
Arm Type
Experimental
Arm Description
One milliliter of cell suspension will be injected intrahepatically under sonographic guidance using a gauge-18 needle.
Intervention Type
Drug
Intervention Name(s)
GXHPC1
Other Intervention Name(s)
hADSCs
Intervention Description
autologous ADSCs
Primary Outcome Measure Information:
Title
Change from Baseline to Week 48 in The METAVIR score
Description
The METAVIR score is a tool used to evaluate the severity of fibrosis seen on a liver biopsy sample. The METAVIR score grades the degree of fibrosis on a 5-point scale from 0 to 4 as follows: F0: No fibrosis F1: Portal fibrosis without septa F2: Portal fibrosis with few septa F3: Numerous septa without cirrhosis F4: Cirrhosis
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline to Week 24 in The METAVIR score
Description
The METAVIR score is a tool used to evaluate the severity of fibrosis seen on a liver biopsy sample. The METAVIR score grades the degree of fibrosis on a 5-point scale from 0 to 4 as follows: F0: No fibrosis F1: Portal fibrosis without septa F2: Portal fibrosis with few septa F3: Numerous septa without cirrhosis F4: Cirrhosis
Time Frame
24 weeks
Title
Change from baseline to Weeks 24, and 48 in Fibroscan® score for liver elasticity
Description
Fibroscan® is a non-invasive modality to measure elasticity of liver tissue. A fibroscan® score is a numerical result between 2-75. A 'normal' Fibroscan range tends to be between 2-7 with an average result being roughly around 5. Scarring of the liver is measured by four stages. F0 = no scarring F1 = mild fibrosis F2 = moderate fibrosis F3 = severe fibrosis F4 = cirrhosis or advanced fibrosis
Time Frame
24 weeks, 48 weeks
Title
Change from baseline to Weeks 12, 24, 36, and 48 in the MELD score
Description
The Model for End-Stage Liver Disease, or MELD, is a scoring system for assessing the severity of the chronic liver disease. MELD score is calculated according to the subject's values for serum total bilirubin, serum creatinine, and INR.
Time Frame
12 weeks, 24 weeks, 36 weeks, 48 weeks
Title
Change from baseline to Weeks 12, 24, 36, and 48 in the Child-Pugh score
Description
The Child-Pugh score is used to assess the prognosis of chronic liver disease, mainly cirrhosis. The score employs five clinical measures of liver disease. Each measure is scored 1-3, with 3 indicating most severe derangement.
Time Frame
12 weeks, 24 weeks, 36 weeks, 48 weeks
Title
Incidence of adverse event(AE) and SAE
Description
An adverse event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not relate with the medicinal (investigational) product.
Time Frame
0-48 weeks
Title
Incidence of serious adverse event (SAE)
Description
An adverse event (AE) or suspected adverse reaction is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes (based on ICH GCP): results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect
Time Frame
0-48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Of either gender aged 20 to 70 years old (inclusive) 2. Diagnosed liver cirrhosis by CT 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. 7. Provision of signed and dated informed consent form Exclusion Criteria: With inadequate coagulation function, as defined by: INR ≥ 1.5, aPTT ≥ 54.0 seconds, platelet count ≤ 50,000/mm3. Note: INR = international normalized ratio, aPTT = activated partial thromboplastin time 2. With evidence of active autoimmune disease 3. With a medical record of malignancy within 5 years prior to screening, excluding curatively treated basal cell skin cancer, squamous cell skin cancer and carcinoma in situ of any site except urinary bladder. 4. With BMI ≤ 15 kg/m2 Note: BMI = body mass index 5. With inadequate hepatic function, as defined by: total bilirubin level > 5.0 mg/dL; AST > 3 × ULN, ALT > 3 × ULN, γ-GT > 4 × ULN, or ALP > 3 × ULN Note: γ-GT = Gamma-glutamyltransferase 6. With inadequate renal function, as defined by serum creatinine > 2.0 mg/dL 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: Established use of oral, injected or implanted hormonal methods of contraception Placement of an intrauterine device (IUD) or intrauterine system (IUS) 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huang Pi Chun
Phone
+886-3-6580768
Ext
332
Email
sabrina@gwoxi.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huang ka Wen, Director
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lee Mi Che, Director
Organizational Affiliation
Hualien Tzu Chi General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
HualienTzu Chi Hospital
City
Hualien City
ZIP/Postal Code
700
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee Mi Che, Directer
Facility Name
National Taiwan University Hospital
City
Taipei county
ZIP/Postal Code
10048
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huang Ka Wen, Director

12. IPD Sharing Statement

Learn more about this trial

A Phase II Open-label Single-arm Study to Evaluate the Efficacy and Safety of ADSCs in Subjects With Liver Cirrhosis

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