Liver Failure, Acute on ChronicPhase 1/2NCT03863002
Safety and Efficacy of Mesenchymal Stem Cell Transplantation for Acute-on-Chronic Liver Failure
A Phase 1/2 study testing Mesenchymal Stem Cell in people with Liver Failure, Acute on Chronic, run by Tianjin Weikai Bioeng., Ltd. at 1 site in China.
Trial summary
Safety and Efficacy of Mesenchymal Stem Cell Transplantation for Acute-on-Chronic Liver Failure Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Liver Failure, Acute on Chronic
- What is being tested?
- Mesenchymal Stem Cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2019to 1 Oct 2022
- Phase
- Phase 1/2
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Informed consent
- Meeting the definition of ACLF: patients with previously diagnosed or undiagnosed chronic liver disease acute decompensated within 4 weeks; significant GI symptom as such fatigue, jaundice; serum total bilirubin [TBil] ≥10 X the upper limit of normal; coagulopathy (international normalized ratio [INR] ≥1.5 or prothrombin activity [PTA] <40%); complicated within 4 weeks by ascites and/or encephalopathy as determined by physical examination.
- Model for End-Stage Liver Disease (MELD) scores ranging 17-30, (MELD(i) = 0.957 × ln(Cr) + 0.378 × ln(bilirubin) + 1.120 × ln(INR) + 0.643);
- Chronic liver disease with definitive etiology such as viral hepatitis, alcohol liver disease, drug induced liver injury or autoimmune liver diseases
- Body weight ≥50kg
Who cannot join
- Serious complications in the previous 2 months (e.g., gastrointestinal bleeding: hemoglobin below 90g/L, serious infection such as sepsis, ascites ultrafiltration, and/or dialysis);
- Malignant jaundice induced by obstructive jaundice or hemolytic jaundice;
- Hepatocellular carcinoma (HCC) diagnosed by radiologic imaging and/or alpha fetoprotein (AFP);
- Tumor diagnosed by ultrasound, CT, MR examination;
- Moderate or severe chronic heart failure (NYHA III-IV), renal replacement therapy, severe chronic pulmonary disease (GOLD III-IV)
- Extrahepatic cholestasis
Show all 17Show fewer
- Hepatic, portal and splenic vein thrombosis diagnosed by doppler ultrasound
- Artificial liver support
- Previous liver transplantation
- Drug abuse in the past 5 years;
- Mental disorders and/or has a family history of mental disorder.
- HIV infection
- Pregnant or breast-feeding females
- Highly allergic
- Patients can not cooperate or mobility
- Enrolled in other clinical trials with 3 months
- Patients who can not provide prior informed consent or refusal to participate
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Weikai Bioeng., Ltd.
Tianjin, Tianjin Municipality
Xiuli Cong, MD, PhD, +86 18512507567, cong_xiuli@163.com
About this study
Official title: Mesenchymal Stem Cell Transplantation for Acute-on-Chronic Liver Failure
Safety and Efficacy of Mesenchymal Stem Cell Transplantation for Acute-on-Chronic Liver Failure
Read the detailed description
Acute-on-chronic liver failure (ACLF) which occurs in patients with chronic liver disease, is a serious live-threatening disease. Currently, the clinical management, such as liver protection, anti-virus medicine, and artificial liver support, has not significantly improve the outcomes, the mortality still remains over 50%. Liver transplantation is the only effective treatment of ACLF, but this therapy is limited by the shortage of donor organs, potential surgical complications, immunological rejection and high medical costs. Mesenchymal stem cell (MSC) is one of adult stem cells, which has been suggested to play a role in amelioration of liver disease, such as: trans-differentiation of MSCs into hepatocytes, immunomodulation, inhibition of fibrosis development, protective effects on hepatic cell and restoration of hepatic cell proliferation capacity.
- Conditions
- Liver Failure, Acute on Chronic
- Being tested
- Mesenchymal Stem Cell
- Keywords
- mesenchymal stem cell
- Medical subject headings
- Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal Stem CellBiological
Mesenchymal stem cell transplantation via peripheral vein: 1.0-10x10^5 MSCs/kg body weight administered via peripheral vein at week 0, 1, 2, 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Standard Medical Treatment | No intervention | Standard Medical Treatment (SMT): All patients received SMT, including nutritional supplementation; administration of human serum albumin (serum albumin <30 g/L), fresh frozen plasma (200-400 mL/day until the INR was <1.5), S-adenosylmethionine (1.0 g/day); or anti-virus treatment for hepatic viruses-related cases, and appropriate treatment for complications such as infections (including of the respiratory tract, urinary tract, biliary tract, and digestive tract and spontaneous peritonitis), encephalopathy, gastrointestinal bleeding, and hepatorenal syndrome [HRS]). |
| Mesenchymal Stem Cell | Experimental | Mesenchymal Stem Cell (MSC): The MSC group received infusions of 1.0 to 10x10^5cells/kg MSCs through the peripheral vein once a week for 4 weeks, in addition to SMT. Receives: Biological: Mesenchymal Stem Cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival rate
Number of participants alive
Measured: 72 weeks after treatment
Secondary outcomes (13)
Adverse reactions
Number of participants with adverse reactions (e.g. fever, rash, and diarrhea )
Measured: Week 1, 2, 4, 8, 12, 24, 36, 48
White blood cell
Change of white blood cell count
Measured: Week 1, 2, 4, 8, 12, 24, 36, 48
Platelet
Change of platelet count
Measured: Week 1, 2, 4, 8, 12, 24, 36, 48
Hemoglobin
Change of hemoglobin level
Measured: Week 1, 2, 4, 8, 12, 24, 36, 48
Creatinine
Change of creatinine level as a surrogate marker of liver function
Measured: Week 1, 2, 4, 8, 12, 24, 36, 48
ALT
Change of alanine aminotransferase (ALT) level as a marker of liver function
Measured: Week 1, 2, 4, 8, 12, 24, 36, 48
ALB
Change of albumin (ALB) level as a maker of liver function
Measured: Week 1, 2, 4, 8, 12, 24, 36, 48
TBil
Change of total Bilirubin (TBil) level as a marker of liver function
Measured: Week 1, 2, 4, 8, 12, 24, 36, 48
INRs
Change of international normalized ratio (INRs) level as a marker of liver function
Measured: Week 1, 2, 4, 8, 12, 24, 36, 48
AFP
Change of alpha fetoprotein (AFP) level as a marker of liver function
Measured: Week 1, 2, 4, 8, 12, 24, 36, 48
MELD scores
Model for End-Stage Liver Disease (MELD) score for assessing the severity of chronic liver disease is measured as absolute change to baseline score
Measured: Week 1, 2, 4, 8, 12, 24, 36, 48
Tumor formation
Number of participants with hepatocellular carcinoma or extrahepatic malignant tumors
Measured: Week 1, 2, 4, 8, 12, 24, 36, 48
Liver failure-associated serious complications
Number of participants with liver failure-associated serious complications, such as infections, encephalopathy, gastrointestinal bleeding and HRS
Measured: Week 1, 2, 4, 8, 12, 24, 36, 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start1 Oct 2019 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Failure, Acute on ChronicStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Weikai Bioeng., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tianjin Nankai Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863002
- Sponsor's protocol ID
- Tianjin Weikai Bioeng., Ltd
- Status last verified
- Apr 2018
- First submitted
- 18 Feb 2019
- Last updated
- 20 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesenchymal Stem Cell Transplantation for Acute-on-Chronic Liver Failure
- ClinicalTrials.gov ID
- NCT03863002
- Acronym / sponsor ID
- Tianjin Weikai Bioeng., Ltd
- Conditions
- Liver Failure, Acute on Chronic
- Keywords
- mesenchymal stem cell
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Tianjin Weikai Bioeng., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Tianjin Nankai Hospital
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 5 Mar 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.
Safety and Efficacy of Mesenchymal Stem Cell Transplantation for Acute-on-Chronic Liver Failure
Detailed description
Acute-on-chronic liver failure (ACLF) which occurs in patients with chronic liver disease, is a serious live-threatening disease. Currently, the clinical management, such as liver protection, anti-virus medicine, and artificial liver support, has not significantly improve the outcomes, the mortality still remains over 50%. Liver transplantation is the only effective treatment of ACLF, but this therapy is limited by the shortage of donor organs, potential surgical complications, immunological rejection and high medical costs. Mesenchymal stem cell (MSC) is one of adult stem cells, which has been suggested to play a role in amelioration of liver disease, such as: trans-differentiation of MSCs into hepatocytes, immunomodulation, inhibition of fibrosis development, protective effects on hepatic cell and restoration of hepatic cell proliferation capacity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Medical Treatment | No intervention | –Standard Medical Treatment (SMT): All patients received SMT, including nutritional supplementation; administration of human serum albumin (serum albumin <30 g/L), fresh frozen plasma (200-400 mL/day until the INR was <1.5), S-adenosylmethionine (1.0 g/day); or anti-virus treatment for hepatic viruses-related cases, and appropriate treatment for complications such as infections (including of the respiratory tract, urinary tract, biliary tract, and digestive tract and spontaneous peritonitis), encephalopathy, gastrointestinal bleeding, and hepatorenal syndrome [HRS]). |
| Mesenchymal Stem Cell | Experimental | Biological: Mesenchymal Stem CellMesenchymal Stem Cell (MSC): The MSC group received infusions of 1.0 to 10x10^5cells/kg MSCs through the peripheral vein once a week for 4 weeks, in addition to SMT. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Informed consent
- Meeting the definition of ACLF: patients with previously diagnosed or undiagnosed chronic liver disease acute decompensated within 4 weeks; significant GI symptom as such fatigue, jaundice; serum total bilirubin [TBil] ≥10 X the upper limit of normal; coagulopathy (international normalized ratio [INR] ≥1.5 or prothrombin activity [PTA] <40%); complicated within 4 weeks by ascites and/or encephalopathy as determined by physical examination.
- Model for End-Stage Liver Disease (MELD) scores ranging 17-30, (MELD(i) = 0.957 × ln(Cr) + 0.378 × ln(bilirubin) + 1.120 × ln(INR) + 0.643);
- Chronic liver disease with definitive etiology such as viral hepatitis, alcohol liver disease, drug induced liver injury or autoimmune liver diseases
- Body weight ≥50kg
Key exclusion criteria (17 listed)
- Serious complications in the previous 2 months (e.g., gastrointestinal bleeding: hemoglobin below 90g/L, serious infection such as sepsis, ascites ultrafiltration, and/or dialysis);
- Malignant jaundice induced by obstructive jaundice or hemolytic jaundice;
- Hepatocellular carcinoma (HCC) diagnosed by radiologic imaging and/or alpha fetoprotein (AFP);
- Tumor diagnosed by ultrasound, CT, MR examination;
- Moderate or severe chronic heart failure (NYHA III-IV), renal replacement therapy, severe chronic pulmonary disease (GOLD III-IV)
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 |
|---|---|---|
| Mesenchymal Stem CellMesenchymal stem cell transplantation via peripheral vein: 1.0-10x10^5 MSCs/kg body weight administered via peripheral vein at week 0, 1, 2, 3 weeks | Biological | Mesenchymal Stem Cell |
Primary outcome
survival rate
Time frame: 72 weeks after treatment
Number of participants alive
13 secondary outcomes
Adverse reactions
Time frame: Week 1, 2, 4, 8, 12, 24, 36, 48
White blood cell
Time frame: Week 1, 2, 4, 8, 12, 24, 36, 48
Platelet
Time frame: Week 1, 2, 4, 8, 12, 24, 36, 48
Hemoglobin
Time frame: Week 1, 2, 4, 8, 12, 24, 36, 48
Creatinine
Time frame: Week 1, 2, 4, 8, 12, 24, 36, 48
ALT
Time frame: Week 1, 2, 4, 8, 12, 24, 36, 48
ALB
Time frame: Week 1, 2, 4, 8, 12, 24, 36, 48
TBil
Time frame: Week 1, 2, 4, 8, 12, 24, 36, 48
INRs
Time frame: Week 1, 2, 4, 8, 12, 24, 36, 48
AFP
Time frame: Week 1, 2, 4, 8, 12, 24, 36, 48
MELD scores
Time frame: Week 1, 2, 4, 8, 12, 24, 36, 48
Tumor formation
Time frame: Week 1, 2, 4, 8, 12, 24, 36, 48
Liver failure-associated serious complications
Time frame: Week 1, 2, 4, 8, 12, 24, 36, 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mesenchymal Stem Cell in people with Liver Failure, Acute on Chronic, run by Tianjin Weikai Bioeng., Ltd. at 1 site in China.
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 5 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: status not confirmed, as of the sponsor's last update on 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 combined 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.
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 Xiuli Cong, MD, PhD (+86 18512507567, cong_xiuli@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival rate (time frame: 72 weeks after treatment). 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 20 Mar 2019.