Liver CirrhosisPhase 1NCT02297867
Clinical Trial Study About Human Adipose-Derived Stem Cells in the Liver Cirrhosis
A Phase 1 study testing ADSCs 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 80 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- ADSCs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesTaiwan
- Study dates
- 13 Jul 2015to 27 Mar 2018
- Phase
- Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Liver cirrhosis investigators with age 20 to 80 years (both inclusive).
- Investigators without Mandatory Communicable Disease (HBV, HCV, HIV, syphilis)
- Investigators without rare disorder
- Coagulation normalities
- Investigators without autoimmune disorder
- Investigators without Acquired Immune Deficiency Syndrome
- Investigators without cancer
- Investigators BMI > 15
Who cannot join
- Pregnant women
- Investigators with acute stroke in one month and unconsciousness
- Investigators with acute myocardial infarction or acute heart failure
- Investigators with serious liver dysfunction and coagulation dysfunction and ascites mild higher
- Investigators with acute respiratory failure or pneumonia
- Kidney Failure: BUN > 50
Show all 17Show fewer
- Anemia: Hematocrit < 25
- Investigators diagnosed with liver cancer or liver metastatic carcinoma
- Investigators with liver abscess
- Investigators with acute Hepatitis
- Investigators with acute infective
- Liver cirrhosis patients with HBV or HCV
- Investigators diagnosed with carcinoma and receiving treatment
- Investigators with Schizophrenia or melancholia
- Investigators received serious surgical operations in 3 months
- Investigators unable to control hypertension (SBP > 180 mmHg, DBP > 110 mmHg) or diabetes (AC sugar > 200 mg/dl)
- Others can't fit into the trial evaluate by investigator
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Gwo Xi Stem Cell Applied Technology Co., Ltd.
Hsinchu, 30261
China Medical University Beigang Hospital
Taichung, Beigang, 65152
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
- ADSCs
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADSCsDrug
Also called hADSCs
autologous ADSCs
| Study group | Role | What they receive |
|---|---|---|
| ADSCs | Experimental | One milliliter of cell suspension will be injected intrahepatically under sonographic guidance using a gauge-18 needle. Receives: Drug: ADSCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
MELD
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.
Measured: 1-6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study start13 Jul 2015
- Primary completion18 Dec 2017
- Study completion27 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gwo Xi Stem Cell Applied Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Sabrina Huang, Gwo Xi Stem Cell Applied Technology Co., Ltd.
- Investigators
- CMU B Hospital, Study director, China Medical University Beigang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02297867
- Sponsor's protocol ID
- 28113265
- Status last verified
- Jul 2017
- First submitted
- 19 Nov 2014
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: CRO
Publications
Harn HJ, Lin SZ, Hung SH, Subeq YM, Li YS, Syu WS, Ding DC, Lee RP, Hsieh DK, Lin PC, Chiou TW. Adipose-derived stem cells can abrogate chemical-induced liver fibrosis and facilitate recovery of liver function. Cell Transplant. 2012;21(12):2753-64. doi: 10.3727/096368912X652959. Epub 2012 Jul 5.
PubMed 22776464
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. 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
- NCT02297867
- Acronym / sponsor ID
- 28113265
- Conditions
- Liver Cirrhosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Gwo Xi Stem Cell Applied Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Jul 2015 (actual)
- Primary completion
- 18 Dec 2017 (actual)
- Study completion
- 27 Mar 2018 (actual)
- First posted
- 21 Nov 2014 (estimated)
- 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 |
|---|---|---|
| ADSCs | Experimental | Drug: ADSCsOne milliliter of cell suspension will be injected intrahepatically under sonographic guidance using a gauge-18 needle. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Liver cirrhosis investigators with age 20 to 80 years (both inclusive).
- Investigators without Mandatory Communicable Disease (HBV, HCV, HIV, syphilis)
- Investigators without rare disorder
- Coagulation normalities
- Investigators without autoimmune disorder
Key exclusion criteria (17 listed)
- Pregnant women
- Investigators with acute stroke in one month and unconsciousness
- Investigators with acute myocardial infarction or acute heart failure
- Investigators with serious liver dysfunction and coagulation dysfunction and ascites mild higher
- Investigators with acute respiratory failure or pneumonia
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 |
|---|---|---|
| ADSCsAlso: hADSCsautologous ADSCs | Drug | ADSCs |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Background: PubMed 22776464Harn HJ, Lin SZ, Hung SH, Subeq YM, Li YS, Syu WS, Ding DC, Lee RP, Hsieh DK, Lin PC, Chiou TW. Adipose-derived stem cells can abrogate chemical-induced liver fibrosis and facilitate recovery of liver function. Cell Transplant. 2012;21(12):2753-64. doi: 10.3727/096368912X652959. Epub 2012 Jul 5.
- Individual participant dataSharing planned: Yes. CRO
Related trials for Liver Cirrhosis
Not yet recruitingObservational study
A Study of Fatigue, Itching and Daily Activities in People With Primary Biliary Cholangitis Starting Elafibranor
Primary Biliary Cholangitis (PBC)
RecruitingPhase 1/2
Nitazoxanide in Spontaneous Bacterial Peritonitis
SBP - Spontaneous Bacterial Peritonitis
RecruitingPhase 3
Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid
Primary Biliary Cirrhosis
RecruitingPhase 1/2
N-Acetylcysteine in the Management of Spontaneous Bacterial Peritonitis
SBP - Spontaneous Bacterial Peritonitis
RecruitingPhase 2/3
Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)
Primary Biliary Cholangitis
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.
CMU B Hospital study director
China Medical University Beigang Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ADSCs 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 8 inclusion and 17 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: finished, as of the sponsor's last update on 17 Apr 2018. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MELD (time frame: 1-6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02297867, which also lists 1 linked publication.
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 17 Apr 2018.