Effect of Different Frequencies of Umbilical Cord-mesenchymal Stem Cells Through Peripheral Vein in Patients With ESLD

End-Stage Liver DIsease Clinical Trial

Official title:

Efficacy and Safety of Different Frequencies of Human Umbilical Cord-mesenchymal Stem Cells Through Peripheral Vein in Patients With End-stage Liver Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06242405
• Other study ID #: XHNKKY-DFSC
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: March 2025

Study information

• Verified date: February 2024
• Source: General Hospital of Shenyang Military Region
• Contact: Xingshun Qi, MD
• Phone: 18909881019
• Email: xingshunqi[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Multiple studies have shown that mesenchymal stem cell has good safety and effectiveness in improving acute or chronic liver injury. Randomized controlled trials have confirmed the efficacy of single infusion of stem cells in treating ESLD. It seems that the multiple infusion is better than single infusion.

Description:

Ninety-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 1 year. The participants will be randomly divided into single-infusion and double-infusion stem cell groups by peripheral vein. 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 in patients at weeks 24 post-infusion.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 92
• Est. completion date: March 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 1. 18-80 years old

• 2. End-stage liver disease

• 3. Signed informed consent

Exclusion Criteria:

• 1. Tumours of the liver or other organs

• 2. Liver transplantation recipients

• 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

• 4. Other diseases that may seriously affect the survival

• 5. Human immunodeficiency syndrome

• 6. Interferon or glucocorticoid therapy within 1 year

• 7. Treated for mental illness

• 8. Participation in other clinical trials within 30 days

• 9. Pregnant or breastfeeding subjects

• 10. Allergic asthma, allergic urticaria, eczema, or a history of multiple drug and food allergies

• 11. Other circumstances that are unsuitable for participation in this study

Related Conditions & MeSH terms

• End Stage Liver Disease
• End-Stage Liver DIsease
• Liver Diseases

Intervention

Biological:
• umbilical cord-mesenchymal stem cells
Umbilical cord mesenchymal stem cells injected through peripheral veins

Locations

Country	Name	City	State
China	General Hospital of Northern Theater Command	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Shenyang Military Region

Country where clinical trial is conducted

China, 

References & Publications (2)

Volarevic V, Nurkovic J, Arsenijevic N, Stojkovic M. Concise review: Therapeutic potential of mesenchymal stem cells for the treatment of acute liver failure and cirrhosis. Stem Cells. 2014 Nov;32(11):2818-23. doi: 10.1002/stem.1818. — View Citation

Wang J, Li Q, Li W, Mendez-Sanchez N, Liu X, Qi X. Stem Cell Therapy for Liver Diseases: Current Perspectives. Front Biosci (Landmark Ed). 2023 Dec 28;28(12):359. doi: 10.31083/j.fbl2812359. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with Child A	Patients with Child A	24 weeks
Secondary	Change in liver function parameters	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	24 weeks
Secondary	Incidence of hepatic decompensation events	Number of patients who will develop gastrointestinal bleeding, ascites and hepatic encephalopathy	24 weeks
Secondary	Survival rate and liver transplant rate	Number of patients surviving and undergoing liver transplantation	24 weeks