Infusion of stem cells for treating end-stage liver disease
Efficacy and Safety of Different Transplantation Routes of Human Umbilical Cord-mesenchymal Stem Cells in Patients With End-stage Liver Disease
This study is testing whether infusing stem cells through different methods can help improve liver function in people with end-stage liver disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | General Hospital of Shenyang Military Region Academic / other |
| Locations | 1 site (Shenyang, Liaoning) |
| Trial ID | NCT06984497 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of human umbilical cord mesenchymal stem cells administered through different routes, specifically peripheral vein and hepatic artery infusions, in patients with end-stage liver disease (ESLD). A total of 32 participants will be enrolled and randomly assigned to one of the two infusion groups. The study will monitor various liver function parameters at 4, 12, and 24 weeks post-infusion to assess the efficacy and safety of the treatments. The goal is to determine which infusion method provides better outcomes for liver function improvement.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 diagnosed with end-stage liver disease who can provide informed consent.
Not a fit: Patients with liver tumors, those who have received liver transplants, or individuals with serious cardiopulmonary diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve liver function and quality of life for patients with end-stage liver disease.
How similar studies have performed: Previous studies have shown promising results with stem cell therapies for liver conditions, suggesting potential efficacy for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. 18-80 years old
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2. End-stage liver disease
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3. Signed informed consent
Exclusion Criteria:
1. Tumours of the liver or other organs
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2. Liver transplantation recipients
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3. 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
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4. Other diseases that may seriously affect the survival
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5. Human immunodeficiency syndrome
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6. Interferon or glucocorticoid therapy within 1 year
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7. Treated for mental illness
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8. Participation in other clinical trials within 30 days
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9. Pregnant or breastfeeding subjects
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10. Allergic asthma, allergic urticaria, eczema, or a history of multiple drug and food allergies
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11. Other circumstances that are unsuitable for participation in this study
Where this trial is running
Shenyang, Liaoning
- General Hospital of Northern Theater Command Recruiting — Shenyang, Liaoning, China (Recruiting)
Study contacts
- Principal investigator: Beilei Zhang, MM — The General Hospital of Northern Theater Command Study Director
- Study coordinator: Xingshun Qi, MD
- Email: xingshunqi@126.com
- Phone: 18909881019
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.