Therapeutic Strategy and the Role of Mesenchymal Stromal Cells for ABO Incompatible Liver Transplantation

Allogeneic umbilical cord-derived mesenchymal stem cells (UC-MSCs) for patients with severe liver failure and receiving ABO incompatible liver transplantation

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000037732

Enrollment

Unknown

Registered

2020-08-31

Start date

2016-08-01

Completion date

Unknown

Last updated

2020-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

severe hepatic failure

Interventions

Experimental group:Umbilical cord-derived mesenchymal stem cells (UC-MSCs)

Control group:Rituximab

Eligibility

Sex/Gender

Male

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Male or female, 18 to 65 years of age; 2. Meld score >25; 3. Eligibility for ABO-incompatibility liver transplantation for severe liver failure according to center standard; 4. Undergoing ABO incompatibility liver transplantation for severe liver failure; 5. Capable of understanding the purpose and risk of the study; 6. Patients or proxy must give written informed consent before any assessment is performed.

Exclusion criteria

Exclusion criteria: 1. Undergoing multi-organ transplantations; 2. Receiving any form of solid organ transplantation in the past; 3. ABO blood group antibodies (IgM and IgG) before surgery >1:64; 4. Pregnant or breastfeeding women; 5. Hepato-biliary malignancies or history of any extrahepatic malignancy; 6. History of pulmonary embolism; 7. Patients with active autoimmune disease; 8. HIV seropositive or HTLV seropositive; 9. Patients with thrombophilia; 10. Pre-existent thrombosis of portal vein; 11. Known abuse for drugs or alcohol; 12. Specific contraindication to UC-MSCs infusion; 13. Severe infection before transplantation (including bacterial, fungus, virus and parasite); 14. Any clinical-relevant condition that might affect study participation and/or study results; 15. Participation in any other intervention trial; 16. Unwillingness or inability to following the study protocol in the investigators opinion.

Design outcomes

Primary

Measure	Time frame
Acute rejection;	—

Secondary

Measure	Time frame
Graft and recipient survivals at transplantation of 12 months;The changes of graft function;The incidence of postoperative complications: Severe infection;The incidence of postoperative complications: Biliary complications;	—

Countries

China

Contacts

Public ContactYang Yang

The Third Affiliated Hospital of Sun Yat-Sen University

yysysu@163.com+86 18922102666

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 23, 2026