End-stage Liver DiseasesNCT06167473
Effect of Different Dosage of Umbilical Cord-mesenchymal Stem Cells Through Peripheral Vein in Patients With ESLD
A study testing umbilical cord-mesenchymal stem cells in people with End-stage Liver Diseases, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial summary
There is a rise in the prevalence of end-stage liver disease during the last decade. End-stage liver disease has become one of the leading causes of death in Western countries. Liver transplantation is the only curative treatment for patients with end-stage liver disease. 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?
- umbilical cord-mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 28 Nov 2023to 30 Dec 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years old
- End-stage liver disease
- Sign 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
- Other diseases that may seriously affect the survival
- Human immunodeficiency syndrome
- Interferon or glucocorticoid therapy within 1 year
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- 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
- 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
Shenyang, Liaoning, 110840
About this study
Official title: Efficacy and Safety of Different Dosage of Umbilical Cord-mesenchymal Stem Cells Through Peripheral Vein in Patients With End-stage Liver Diseases
There is a rise in the prevalence of end-stage liver disease during the last decade. End-stage liver disease has become one of the leading causes of death in Western countries. Liver transplantation is the only curative treatment for patients with end-stage liver disease. However, the shortage of donor, high cost, and postoperative complications limit its wide application in clinical practice. At present, stem cell-based therapy has been developed as an alternative treatment for end-stage liver disease. Stem cells can be differentiated into a variety of cell types, and stem cell transplantation, mainly umbilical cord-mesenchymal stem cells, has attracted more and more attention in the treatment of end-stage liver disease. The investigators therefore conduct a randomised controlled trial to investigate the efficacy and safety of human umbilical cord tissue mesenchymal stem cells for the treatment of end-stage liver disease.
Read the detailed description
Twenty-two subjects with end-stage liver disease attending the Department of Gastroenterology of the General Hospital of the Northern Theatre of Operations are expected to be enrolled over a period of 1 year. The participants will be randomly divided into a low-dose stem cell group (1×10^6cells/kg per infusion) and a medium-high-dose stem cell group (3×10^6cells/kg per infusion), which are infused by peripheral vein. The investigators will observe ALT, AST, ALP, TBIL, ALB, PT, INR, MELD score, and Child-Pugh score in patients at weeks 1, 4, 8, 12, 24, and 48 post-infusion.
- Conditions
- End-stage Liver Diseases
- Being tested
- umbilical cord-mesenchymal stem cells
- 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.
umbilical cord-mesenchymal stem cellsBiological
Also called UC-MSCs
Different dosage of umbilical cord-mesenchymal stem cells through peripheral vein
| Study group | Role | What they receive |
|---|---|---|
| low-dose stem cell group (1×10^6cells/kg per infusion) | Experimental | Peripheral intravenous infusion of low-dose stem cells Receives: Biological: umbilical cord-mesenchymal stem cells |
| medium-high-dose stem cell group (3×10^6cells/kg per infusion) | Experimental | Peripheral intravenous infusion of medium-high-dose stem cells Receives: Biological: umbilical cord-mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
Number of subjects surviving after one year
Measured: 1 year
Secondary outcomes (2)
Changes in liver function
The values of alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin, serum albumin, prothrombin time, and international normalized ratio and the scores of MELD and Child-Pugh
Measured: 1, 4, 8, 12, 24, and 48 weeks
Incidence of hepatic decompensation events
Number of patients who developed gastrointestinal bleeding, ascites and hepatic encephalopathy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start28 Nov 2023
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Model description
- Before enrollment, all patients and/or their relatives will be informed about the study protocol, and sign the written informed consent forms. Eligible patients are randomly assigned at a ratio of 1:1 to low-dose stem cell group (1×10\^6cells/kg per infusion) and a medium-high-dose stem cell group (3×10\^6cells/kg per infusion).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
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
- Mengfan Ruan, MM, Principal investigator, The General Hospital of Northern Theater Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167473
- Sponsor's protocol ID
- XHNKKY-DDSC
- Status last verified
- Aug 2025
- First submitted
- 23 Nov 2023
- Last updated
- 3 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang L, Ma XJ, Fei YY, Han HT, Xu J, Cheng L, Li X. Stem cell therapy in liver regeneration: Focus on mesenchymal stem cells and induced pluripotent stem cells. Pharmacol Ther. 2022 Apr;232:108004. doi: 10.1016/j.pharmthera.2021.108004. Epub 2021 Sep 28.
PubMed 34597754Khan S, Khan RS, Newsome PN. Cell Therapy for Liver Disease: From Promise to Reality. Semin Liver Dis. 2020 Nov;40(4):411-426. doi: 10.1055/s-0040-1717096. Epub 2020 Dec 24.
PubMed 33764490Alfaifi M, Eom YW, Newsome PN, Baik SK. Mesenchymal stromal cell therapy for liver diseases. J Hepatol. 2018 Jun;68(6):1272-1285. doi: 10.1016/j.jhep.2018.01.030. Epub 2018 Feb 7.
PubMed 29425678
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Different Dosage of Umbilical Cord-mesenchymal Stem Cells Through Peripheral Vein in Patients With End-stage Liver Diseases
- ClinicalTrials.gov ID
- NCT06167473
- Acronym / sponsor ID
- XHNKKY-DDSC
- Conditions
- End-stage Liver Diseases
- Keywords
- cirrhosis, end-stage liver diseases, umbilical cord-mesenchymal stem cells, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 12 Dec 2023 (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 is a rise in the prevalence of end-stage liver disease during the last decade. End-stage liver disease has become one of the leading causes of death in Western countries. Liver transplantation is the only curative treatment for patients with end-stage liver disease. However, the shortage of donor, high cost, and postoperative complications limit its wide application in clinical practice. At present, stem cell-based therapy has been developed as an alternative treatment for end-stage liver disease. Stem cells can be differentiated into a variety of cell types, and stem cell transplantation, mainly umbilical cord-mesenchymal stem cells, has attracted more and more attention in the treatment of end-stage liver disease. The investigators therefore conduct a randomised controlled trial to investigate the efficacy and safety of human umbilical cord tissue mesenchymal stem cells for the treatment of end-stage liver disease.
Detailed description
Twenty-two subjects with end-stage liver disease attending the Department of Gastroenterology of the General Hospital of the Northern Theatre of Operations are expected to be enrolled over a period of 1 year. The participants will be randomly divided into a low-dose stem cell group (1×10^6cells/kg per infusion) and a medium-high-dose stem cell group (3×10^6cells/kg per infusion), which are infused by peripheral vein. The investigators will observe ALT, AST, ALP, TBIL, ALB, PT, INR, MELD score, and Child-Pugh score in patients at weeks 1, 4, 8, 12, 24, and 48 post-infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Before enrollment, all patients and/or their relatives will be informed about the study protocol, and sign the written informed consent forms. Eligible patients are randomly assigned at a ratio of 1:1 to low-dose stem cell group (1×10^6cells/kg per infusion) and a medium-high-dose stem cell group (3×10^6cells/kg per infusion).
| Arm | Type | Receives |
|---|---|---|
| low-dose stem cell group (1×10^6cells/kg per infusion) | Experimental | Biological: umbilical cord-mesenchymal stem cellsPeripheral intravenous infusion of low-dose stem cells |
| medium-high-dose stem cell group (3×10^6cells/kg per infusion) | Experimental | Biological: umbilical cord-mesenchymal stem cellsPeripheral intravenous infusion of medium-high-dose stem cells |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-80 years old
- End-stage liver disease
- Sign informed consent
Key exclusion criteria (11 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
- Other diseases that may seriously affect the survival
- Human immunodeficiency syndrome
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 |
|---|---|---|
| umbilical cord-mesenchymal stem cellsAlso: UC-MSCsDifferent dosage of umbilical cord-mesenchymal stem cells through peripheral vein | Biological | low-dose stem cell group (1×10^6cells/kg per infusion), medium-high-dose stem cell group (3×10^6cells/kg per infusion) |
Primary outcome
Survival rate
Time frame: 1 year
Number of subjects surviving after one year
2 secondary outcomes
Changes in liver function
Time frame: 1, 4, 8, 12, 24, and 48 weeks
Incidence of hepatic decompensation events
Time frame: 1 year
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 3 Apr 2026.
- Results publication: PubMed 34597754Zhang L, Ma XJ, Fei YY, Han HT, Xu J, Cheng L, Li X. Stem cell therapy in liver regeneration: Focus on mesenchymal stem cells and induced pluripotent stem cells. Pharmacol Ther. 2022 Apr;232:108004. doi: 10.1016/j.pharmthera.2021.108004. Epub 2021 Sep 28.
- Results publication: PubMed 33764490Khan S, Khan RS, Newsome PN. Cell Therapy for Liver Disease: From Promise to Reality. Semin Liver Dis. 2020 Nov;40(4):411-426. doi: 10.1055/s-0040-1717096. Epub 2020 Dec 24.
- Results publication: PubMed 29425678Alfaifi M, Eom YW, Newsome PN, Baik SK. Mesenchymal stromal cell therapy for liver diseases. J Hepatol. 2018 Jun;68(6):1272-1285. doi: 10.1016/j.jhep.2018.01.030. Epub 2018 Feb 7.
- 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.
Mengfan Ruan, MM principal investigator
The General Hospital of Northern Theater Command
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing umbilical cord-mesenchymal stem cells 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 3 inclusion and 11 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 3 Apr 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?
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?
Survival rate (time frame: 1 year). 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 NCT06167473, which also lists 3 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 3 Apr 2026.