Liver CirrhosisPhase 2NCT04088058
A Phase II Open-label Single-arm Study to Evaluate the Efficacy and Safety of ADSCs in Subjects With Liver Cirrhosis
A Phase 2 study testing GXHPC1 in people with Liver Cirrhosis, run by Gwo Xi Stem Cell Applied Technology Co., Ltd. at 2 sites in Taiwan.
Trial summary
The aim of the investigators study was to investigate the safety and efficacy of autologous ADSCs for the clinical treatment of liver cirrhosis. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- GXHPC1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesTaiwan
- Study dates
- 16 Nov 2019to 19 Apr 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Recruiting
HualienTzu Chi Hospital
Hualien City, 700
Lee Mi Che, Directer
- Recruiting
National Taiwan University Hospital
Taipei County, 10048
Huang Ka Wen, Director
About this study
Official title: Adipose-Derived Stem Cells (ADSCs) Injections for Liver Cirrhosis
The aim of the investigators study was to investigate the safety and efficacy of autologous ADSCs for the clinical treatment of liver cirrhosis.
Read the detailed description
One milliliter of cell suspension will be injected intrahepatically under sonographic guidance using a gauge-18 needle.
- Conditions
- Liver Cirrhosis
- Being tested
- GXHPC1
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GXHPC1Drug
Also called hADSCs
autologous ADSCs
| Study group | Role | What they receive |
|---|---|---|
| GXHPC1 | Experimental | One milliliter of cell suspension will be injected intrahepatically under sonographic guidance using a gauge-18 needle. Receives: Drug: GXHPC1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 weeks
Secondary outcomes (6)
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
Measured: 24 weeks
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
Measured: 24 weeks, 48 weeks
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.
Measured: 12 weeks, 24 weeks, 36 weeks, 48 weeks
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.
Measured: 12 weeks, 24 weeks, 36 weeks, 48 weeks
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.
Measured: 0-48 weeks
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
Measured: 0-48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start16 Nov 2019
- Primary completion19 Apr 2025 (estimated)
- Study completion19 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gwo Xi Stem Cell Applied Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huang ka Wen, Director, Principal investigator, National Taiwan University HospitalLee Mi Che, Director, Principal investigator, Hualien Tzu Chi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04088058
- Sponsor's protocol ID
- GXHPC1
- Status last verified
- Apr 2023
- First submitted
- 11 Sep 2019
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adipose-Derived Stem Cells (ADSCs) Injections for Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT04088058
- Acronym / sponsor ID
- GXHPC1
- Conditions
- Liver Cirrhosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Gwo Xi Stem Cell Applied Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Nov 2019 (actual)
- Primary completion
- 19 Apr 2025 (estimated)
- Study completion
- 19 Apr 2025 (estimated)
- First posted
- 12 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GXHPC1 | Experimental | Drug: GXHPC1One milliliter of cell suspension will be injected intrahepatically under sonographic guidance using a gauge-18 needle. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GXHPC1Also: hADSCsautologous ADSCs | Drug | GXHPC1 |
Primary outcome
Change from Baseline to Week 48 in The METAVIR score
Time frame: 48 weeks
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
6 secondary outcomes
Change from Baseline to Week 24 in The METAVIR score
Time frame: 24 weeks
Change from baseline to Weeks 24, and 48 in Fibroscan® score for liver elasticity
Time frame: 24 weeks, 48 weeks
Change from baseline to Weeks 12, 24, 36, and 48 in the MELD score
Time frame: 12 weeks, 24 weeks, 36 weeks, 48 weeks
Change from baseline to Weeks 12, 24, 36, and 48 in the Child-Pugh score
Time frame: 12 weeks, 24 weeks, 36 weeks, 48 weeks
Incidence of adverse event(AE) and SAE
Time frame: 0-48 weeks
Incidence of serious adverse event (SAE)
Time frame: 0-48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huang ka Wen, Director principal investigator
National Taiwan University Hospital
Lee Mi Che, Director principal investigator
Hualien Tzu Chi General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GXHPC1 in people with Liver Cirrhosis, run by Gwo Xi Stem Cell Applied Technology Co., Ltd. at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huang Pi Chun (+886-3-6580768 ext. 332, sabrina@gwoxi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline to Week 48 in The METAVIR score (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2023.