End-Stage Liver DiseasesNCT06984497
Human Umbilical Cord-mesenchymal Stem Cells Via Different Transplantation Routes in ESLD
A study testing Infusion of umbilical cord-mesenchymal stem cells through peripheral veins and Infusion of umbilical cord-mesenchymal stem cells through hepatic artery in people with End-Stage Liver Diseases, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial summary
Stem cells are non-terminal cells that can self renew and replicate through symmetric or asymmetric division, with the potential to differentiate into different types of cells and tissues. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- End-Stage Liver Diseases
- What is being tested?
- Infusion of umbilical cord-mesenchymal stem cells through peripheral veins and Infusion of umbilical cord-mesenchymal stem cells through hepatic artery
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years old
- -
- End-stage liver disease
- -
- Signed informed consent
Who cannot join
- Tumours of the liver or other organs
- -
- Liver transplantation recipients
- -
- Acute myocardial infarction, acute heart failure, type I and type II respiratory failure, pulmonary embolism, acute cerebral infarction, acute cerebral haemorrhage and other serious cardiopulmonary diseases
- -
Show all 23Show fewer
- Other diseases that may seriously affect the survival
- -
- Human immunodeficiency syndrome
- -
- Interferon or glucocorticoid therapy within 1 year
- -
- Treated for mental illness
- -
- Participation in other clinical trials within 30 days
- -
- Pregnant or breastfeeding subjects
- -
- Allergic asthma, allergic urticaria, eczema, or a history of multiple drug and food allergies
- -
- Severe coagulopathy or renal dysfunction
- -
- Other circumstances that are unsuitable for participation in this study
Trial locations and contacts
1 site in 1 country.
China1 site
General Hospital of Northern Theater Command Recruiting
Shenyang, Liaoning, 110840
About this study
Official title: Efficacy and Safety of Different Transplantation Routes of Human Umbilical Cord-mesenchymal Stem Cells in Patients With End-stage Liver Disease
Stem cells are non-terminal cells that can self renew and replicate through symmetric or asymmetric division, with the potential to differentiate into different types of cells and tissues. Multiple studies have shown that human umbilical cord mesenchymal stem cell has good safety and effectiveness in improving acute or chronic liver injury.
Stem cell therapy for end-stage liver disease (ESLD) can be administered through various routes, among which hepatic artery and peripheral vein infusions are the most commonly used in clinical practice. The efficacy of hepatic artery infusion appears to be greater than that of peripheral vein infusion.
Read the detailed description
Thirty-two participants with end-stage liver disease admitted to the Department of Gastroenterology of the General Hospital of Northern Theater Command are expected to be enrolled over a period of 6 months. They will be randomly assigned to peripheral vein infusion and hepatic arterial infusion of human umbilical cord mesenchymal stem cell groups. The investigators will observe alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin, albumin, prothrombin time, international normalized ratio, model for end-stage liver disease score, and Child-Pugh score at weeks 4, 12, and 24 post-infusion.
- Conditions
- End-Stage Liver Diseases
- Being tested
- Infusion of umbilical cord-mesenchymal stem cells through peripheral veins, Infusion of umbilical cord-mesenchymal stem cells through hepatic artery
- Keywords
- cirrhosis, end-stage liver diseases, umbilical cord-mesenchymal stem cells, randomized controlled trial
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infusion of umbilical cord-mesenchymal stem cells through peripheral veinsOther
Umbilical cord-mesenchymal stem cells injected through peripheral veins
Infusion of umbilical cord-mesenchymal stem cells through hepatic arteryOther
Umbilical cord-mesenchymal stem cells injected through hepatic artery
| Study group | Role | What they receive |
|---|---|---|
| Peripheral veins infusion group | Experimental | Peripheral veins infusion of stem cells Receives: Other: Infusion of umbilical cord-mesenchymal stem cells through peripheral veins |
| Hepatic arterial infusion group | Experimental | Hepatic arterial infusion of stem cells Receives: Other: Infusion of umbilical cord-mesenchymal stem cells through hepatic artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
Number of subjects surviving after 24 weeks
Measured: 24 weeks
Secondary outcomes (3)
Changes in Model for End-Stage Liver Disease (MELD) score
The Model for End-Stage Liver Disease (MELD) score ranges from 6 to 40, with higher values indicating more severe liver dysfunction and an increased risk of mortality.
Measured: 4, 12, and 24 weeks
Changes in Child-Pugh score
The Child-Pugh score is categorized into class A (5-6 points), class B (7-9 points), and class C (≥10 points), reflecting progressive liver disease severity. Higher Child-Pugh scores are associated not only with increased mortality risk but also with a significantly higher incidence of complications, such as gastrointestinal bleeding and infections.
Measured: 4, 12, and 24 weeks
Incidence of hepatic decompensation events
Number of patients who developed gastrointestinal bleeding, ascites, and hepatic encephalopathy
Measured: 4, 12, and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start1 Feb 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for End-Stage Liver DiseasesStudies 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
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingshun Qi, General Hospital of Shenyang Military Region
- Investigators
- Xingshun Qi, MD, Study director, The General Hospital of Northern Theater Command Study DirectorLiyan Dong, MM, Principal investigator, The General Hospital of Northern Theater Command Study Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984497
- Sponsor's protocol ID
- XHNKKY-DRSC
- Status last verified
- Sep 2026
- First submitted
- 12 May 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lyra AC, Soares MB, da Silva LF, Braga EL, Oliveira SA, Fortes MF, Silva AG, Brustolim D, Genser B, Dos Santos RR, Lyra LG. Infusion of autologous bone marrow mononuclear cells through hepatic artery results in a short-term improvement of liver function in patients with chronic liver disease: a pilot randomized controlled study. Eur J Gastroenterol Hepatol. 2010 Jan;22(1):33-42. doi: 10.1097/MEG.0b013e32832eb69a.
PubMed 19654548Zhou GP, Jiang YZ, Sun LY, Zhu ZJ. Therapeutic effect and safety of stem cell therapy for chronic liver disease: a systematic review and meta-analysis of randomized controlled trials. Stem Cell Res Ther. 2020 Sep 25;11(1):419. doi: 10.1186/s13287-020-01935-w.
PubMed 32977828
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Different Transplantation Routes of Human Umbilical Cord-mesenchymal Stem Cells in Patients With End-stage Liver Disease
- ClinicalTrials.gov ID
- NCT06984497
- Acronym / sponsor ID
- XHNKKY-DRSC
- Conditions
- End-Stage Liver Diseases
- Keywords
- cirrhosis, end-stage liver diseases, umbilical cord-mesenchymal stem cells, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 May 2025 (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.
Stem cells are non-terminal cells that can self renew and replicate through symmetric or asymmetric division, with the potential to differentiate into different types of cells and tissues. Multiple studies have shown that human umbilical cord mesenchymal stem cell has good safety and effectiveness in improving acute or chronic liver injury.
Stem cell therapy for end-stage liver disease (ESLD) can be administered through various routes, among which hepatic artery and peripheral vein infusions are the most commonly used in clinical practice. The efficacy of hepatic artery infusion appears to be greater than that of peripheral vein infusion.
Detailed description
Thirty-two participants with end-stage liver disease admitted to the Department of Gastroenterology of the General Hospital of Northern Theater Command are expected to be enrolled over a period of 6 months. They will be randomly assigned to peripheral vein infusion and hepatic arterial infusion of human umbilical cord mesenchymal stem cell groups. The investigators will observe alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin, albumin, prothrombin time, international normalized ratio, model for end-stage liver disease score, and Child-Pugh score at weeks 4, 12, and 24 post-infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peripheral veins infusion group | Experimental | Other: Infusion of umbilical cord-mesenchymal stem cells through peripheral veinsPeripheral veins infusion of stem cells |
| Hepatic arterial infusion group | Experimental | Other: Infusion of umbilical cord-mesenchymal stem cells through hepatic arteryHepatic arterial infusion of stem cells |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-80 years old
- -
- End-stage liver disease
- -
- Signed informed consent
Key exclusion criteria (23 listed)
- Tumours of the liver or other organs
- -
- Liver transplantation recipients
- -
- Acute myocardial infarction, acute heart failure, type I and type II respiratory failure, pulmonary embolism, acute cerebral infarction, acute cerebral haemorrhage and other serious cardiopulmonary diseases
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 |
|---|---|---|
| Infusion of umbilical cord-mesenchymal stem cells through peripheral veinsUmbilical cord-mesenchymal stem cells injected through peripheral veins | Other | Peripheral veins infusion group |
| Infusion of umbilical cord-mesenchymal stem cells through hepatic arteryUmbilical cord-mesenchymal stem cells injected through hepatic artery | Other | Hepatic arterial infusion group |
Primary outcome
Survival rate
Time frame: 24 weeks
Number of subjects surviving after 24 weeks
3 secondary outcomes
Changes in Model for End-Stage Liver Disease (MELD) score
Time frame: 4, 12, and 24 weeks
Changes in Child-Pugh score
Time frame: 4, 12, and 24 weeks
Incidence of hepatic decompensation events
Time frame: 4, 12, and 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Results publication: PubMed 19654548Lyra AC, Soares MB, da Silva LF, Braga EL, Oliveira SA, Fortes MF, Silva AG, Brustolim D, Genser B, Dos Santos RR, Lyra LG. Infusion of autologous bone marrow mononuclear cells through hepatic artery results in a short-term improvement of liver function in patients with chronic liver disease: a pilot randomized controlled study. Eur J Gastroenterol Hepatol. 2010 Jan;22(1):33-42. doi: 10.1097/MEG.0b013e32832eb69a.
- Results publication: PubMed 32977828Zhou GP, Jiang YZ, Sun LY, Zhu ZJ. Therapeutic effect and safety of stem cell therapy for chronic liver disease: a systematic review and meta-analysis of randomized controlled trials. Stem Cell Res Ther. 2020 Sep 25;11(1):419. doi: 10.1186/s13287-020-01935-w.
- Individual participant dataSharing planned: No
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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.
Xingshun Qi, MD study director
The General Hospital of Northern Theater Command Study Director
Liyan Dong, MM principal investigator
The General Hospital of Northern Theater Command Study Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infusion of umbilical cord-mesenchymal stem cells through peripheral veins and Infusion of umbilical cord-mesenchymal stem cells through hepatic artery in people with End-Stage Liver Diseases, run by General Hospital of Shenyang Military Region 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 23 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: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Survival rate (time frame: 24 weeks). 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 NCT06984497, which also lists 2 linked publications.
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 15 Sep 2026.