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

Liver Transplantation Clinical Trial

Official title:

MSC for ABO Incompatible Liver Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02706132
• Other study ID #: 2015-08
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: March 8, 2016
• Last updated: March 8, 2016
• Start date: February 2014
• Est. completion date: March 2017

Study information

• Verified date: March 2016
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: Yang Yang
• Phone: 862085252276
• Email: yysysu[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether MSCs are safe and effective in reducing the primary nonfunction (PNF), acute rejection and Ischemic-type Biliary Lesions (ITBLs) morbidity in ABO-incompatible Liver Transplantation.

Description:

ABO incompatible liver transplantations is considered to be a rescue option in emergency transplantation.The A、B antibodies to grafts bind to the graft endothelium and activate complement, which attracts and activates neutrophils and platelets and increases the permeability of the endothelium. The neutrophils exude, the platelets aggregate, and the small vessels of the graft get thrombosed, resulting in ischemic damage,leading nonfunction grafts.In addition, if the A、 B antibodies remain high level, it can lead to acute humoral immune rejection. A lot of research confirmed that the ABO incompatible is a risk factor of postoperative short- and long-term survival. And mesenchymal stromal cells (MSCs) are characterized by the properties of immunosuppressive and regenerative properties, which make MSCs great attractive in treating immunological diseases (including transplant rejection) and organ/tissue ischemic injury. So we conduct this clinical study,to confirm the effect of MSCs in ABO incompatible liver transplantation by comparing the incidence of primary nonfunction, acute rejection, biliary complications and survival rates.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• First liver transplantation with a ABO-incompatible graft(B?A,AB?A,A?B,AB?B,A?O,B?O,AB?O).

• Ages of 18 or older.

• Patients receive liver transplantation due to benign end stage liver disease.

• Patients or legal agent must be able to give informed consent.

Exclusion Criteria:

• Second or combined organ transplant recipient.

• Combined transplantations such as simultaneous liver/kidney transplants

• Malignant disease.

• Uncontrol bacterial, fungal, viral or parasitic infection.

• Withdraw or unable to finish the follow-up.

• Unwilling to sign informed consent.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Biological:
• Mesenchymal Stem Cells(MSCs)
Six doses of 1*10^6/kg body weight MSCs are given, intravenously.

Locations

Country	Name	City	State
China	The Third Affiliated Hospital,Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: one year graft survival rate		one year	Yes
Secondary	the rate of acute rejection		one year	Yes
Secondary	the rate of ischemic-type biliary lesions		one year	Yes
Secondary	safety: rate of (serious) adverse events in the study population	adverse events include: allergic reaction, prothrombotic effects, opportunistic infections and malignancy	one year	Yes