Liver CirrhosisNCT03209986
Trial of Mesenchymal Stem Cell Transplantation in Decompensated Liver Cirrhosis
A study testing mesenchymal stem cell transplantation via peripheral vein and mesenchymal stem cell in people with Liver Cirrhosis, run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial summary
There has been great interest in recent years to take advantage of stem cells to treat liver cirrhosis. Mesenchymal stem cells (MSC) has been shown to be safe and effective for liver diseases in some studies. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- mesenchymal stem cell transplantation via peripheral vein and mesenchymal stem cell
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 8 Nov 2017to 31 Dec 2019
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65 years
- HBV -related liver cirrhosis
- Child-Pugh score ≥7
- With presentations of decompensation
- Written consent
Who cannot join
- Hepatocellular carcinoma or other malignancies
- Severe problems in other vital organs(e.g.the heart,renal or lungs)
- Pregnant or lactating women
- Severe bacteria infection
- Anticipated with difficulty of follow-up observation
- Coinfection with HIV or other viral hepatitis.
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- Drug abuse or alcohol abuse
- History of severe allergy to biological products
- Other candidates who are judged to be not applicable to this study by doctors -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital of Digestive Disease, Xijing Hospital
Xi'an, Shaanxi, 710032
Ying Han, Ph.D, 86-29-84771539, hanying@fmmu.edu.cn
About this study
Official title: Randomized Control Trial of Mesenchymal Stem Cell Transplantation in Decompensated Liver Cirrhosis Resulted From Viral Hepatitis
There has been great interest in recent years to take advantage of stem cells to treat liver cirrhosis. Mesenchymal stem cells (MSC) has been shown to be safe and effective for liver diseases in some studies. Randomization controlled studies are needed to confirm the long term effect of MSC treatment for liver cirrhosis. This study aimed to investigate the safety and efficacy of mesenchymal stem cells in hepatitis B and C related liver cirrhosis patients.
This study is an open-label multicenter randomized control study. Patients with with decompensated cirrhosis will be randomly assigned to receive MSC treatment plus standard medical care(treatment）or standard medical care (control). Three times of MSC infusion (1x10E6 cells/kg body weight) via peripheral vein will be given to the experimental group (once in 4 weeks). The primary outcome is absolute change in liver function indexes and and scores. Secondary outcomes are cirrhosis-related complications, symptoms, life quality, and survival.
- Conditions
- Liver Cirrhosis
- Being tested
- mesenchymal stem cell transplantation via peripheral vein, mesenchymal stem cell
- Keywords
- Liver Cirrhosis, Mesenchymal Sem Cells
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mesenchymal stem cell transplantation via peripheral veinProcedure or surgery
1x10E6 MSCs/kg body weight will be administered via peripheral vein for 3 times at week 0, 4 and 8
mesenchymal stem cellOther
mesenchymal stem cell infusion produced by Cell products of National Engineering Research Center(short for CPNERC), Tianjin, China
| Study group | Role | What they receive |
|---|---|---|
| MSC group | Experimental | mesenchymal stem cell transplantation via peripheral vein: 1x10E6 MSCs/kg body weight administered via peripheral vein at week 0, 4, 8. Receives: Procedure: mesenchymal stem cell transplantation via peripheral vein; Other: mesenchymal stem cell |
| control | No intervention | Standard medication for viral hepatitis and cirrhosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Change of liver functions as assessed by MELD score
Change of liver functions as assessed by MELD score (MELD, Model for End-Stage Liver Disease Score: MELD = 3.78×ln[serum bilirubin (mg/dL)] + 11.2×ln[INR] + 9.57×ln[serum creatinine (mg/dL)] + 6.43)
Measured: 1 year
Safety: Adverse events as assessed according to CTCAE 4.03
Adverse events as assessed according to CTCAE 4.03
Measured: 1 year
Secondary outcomes (3)
Survival Benefit: Survival Rate at different time points
survival rate at different time points
Measured: 1 year, 2 year and 5 years
Histological change of the liver: Histological scores assessed by liver biopsy
histological scores assessed by liver biopsy at baseline and after treatment
Measured: 1 year, 2 year and 5 years
Clinical benefit: Incidences of cirrhosis-related complications such as GI bleeding, ascites, hepatorenal syndrome, hepatoencephalopathy
Incidences of cirrhosis-related complications such as GI bleeding, ascites, hepatorenal syndrome, hepatoencephalopathy
Measured: 1, 2 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start8 Nov 2017
- Primary completion30 Jun 2019 (estimated)
- Study completion31 Dec 2019 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Ying, Xijing Hospital of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03209986
- Sponsor's protocol ID
- XJMSC0001
- Status last verified
- Sep 2018
- First submitted
- 30 Jun 2017
- Last updated
- 11 Sep 2018
- 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 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of Mesenchymal Stem Cell Transplantation in Decompensated Liver Cirrhosis Resulted From Viral Hepatitis
- ClinicalTrials.gov ID
- NCT03209986
- Acronym / sponsor ID
- XJMSC0001
- Conditions
- Liver Cirrhosis
- Keywords
- Liver Cirrhosis, Mesenchymal Sem Cells
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- 8 Nov 2017 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 6 Jul 2017 (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.
There has been great interest in recent years to take advantage of stem cells to treat liver cirrhosis. Mesenchymal stem cells (MSC) has been shown to be safe and effective for liver diseases in some studies. Randomization controlled studies are needed to confirm the long term effect of MSC treatment for liver cirrhosis. This study aimed to investigate the safety and efficacy of mesenchymal stem cells in hepatitis B and C related liver cirrhosis patients.
This study is an open-label multicenter randomized control study. Patients with with decompensated cirrhosis will be randomly assigned to receive MSC treatment plus standard medical care(treatment）or standard medical care (control). Three times of MSC infusion (1x10E6 cells/kg body weight) via peripheral vein will be given to the experimental group (once in 4 weeks). The primary outcome is absolute change in liver function indexes and and scores. Secondary outcomes are cirrhosis-related complications, symptoms, life quality, and survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MSC group | Experimental | Procedure: mesenchymal stem cell transplantation via peripheral vein, Other: mesenchymal stem cellmesenchymal stem cell transplantation via peripheral vein: 1x10E6 MSCs/kg body weight administered via peripheral vein at week 0, 4, 8. |
| control | No intervention | –Standard medication for viral hepatitis and cirrhosis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18-65 years
- HBV -related liver cirrhosis
- Child-Pugh score ≥7
- With presentations of decompensation
- Written consent
Key exclusion criteria (9 listed)
- Hepatocellular carcinoma or other malignancies
- Severe problems in other vital organs(e.g.the heart,renal or lungs)
- Pregnant or lactating women
- Severe bacteria infection
- Anticipated with difficulty of follow-up observation
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 cell transplantation via peripheral vein1x10E6 MSCs/kg body weight will be administered via peripheral vein for 3 times at week 0, 4 and 8 | Procedure or surgery | MSC group |
| mesenchymal stem cellmesenchymal stem cell infusion produced by Cell products of National Engineering Research Center(short for CPNERC), Tianjin, China | Other | MSC group |
Primary outcome
Efficacy: Change of liver functions as assessed by MELD score
Time frame: 1 year
Change of liver functions as assessed by MELD score (MELD, Model for End-Stage Liver Disease Score: MELD = 3.78×ln[serum bilirubin (mg/dL)] + 11.2×ln[INR] + 9.57×ln[serum creatinine (mg/dL)] + 6.43)
Safety: Adverse events as assessed according to CTCAE 4.03
Time frame: 1 year
Adverse events as assessed according to CTCAE 4.03
3 secondary outcomes
Survival Benefit: Survival Rate at different time points
Time frame: 1 year, 2 year and 5 years
Histological change of the liver: Histological scores assessed by liver biopsy
Time frame: 1 year, 2 year and 5 years
Clinical benefit: Incidences of cirrhosis-related complications such as GI bleeding, ascites, hepatorenal syndrome, hepatoencephalopathy
Time frame: 1, 2 and 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
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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 study testing mesenchymal stem cell transplantation via peripheral vein and mesenchymal stem cell in people with Liver Cirrhosis, run by Xijing Hospital of Digestive Diseases 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 9 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 11 Sep 2018. 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.
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 Changcun Guo, MD (862984771539, guochc@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy: Change of liver functions as assessed by MELD score (time frame: 1 year). The study lists 2 primary outcomes in all. 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 11 Sep 2018.