Therapeutic Strategy and the Role of Mesenchymal Stromal Cells for ABO Incompatible Liver Transplantation
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: The MSCs group The group of patients receive allogeneic MSCs therapies. |
Biological: Mesenchymal Stem Cells(MSCs)
Six doses of 1*10^6/kg body weight MSCs are given, intravenously.
|
Outcome Measures
Primary Outcome Measures
- Efficacy: one year graft survival rate [one year]
Secondary Outcome Measures
- the rate of acute rejection [one year]
- the rate of ischemic-type biliary lesions [one year]
- safety: rate of (serious) adverse events in the study population [one year]
adverse events include: allergic reaction, prothrombotic effects, opportunistic infections and malignancy
Eligibility Criteria
Criteria
Inclusion Criteria:
-
First liver transplantation with a ABO-incompatible graft(B→A，AB→A，A→B，AB→B，A→O，B→O，AB→O).
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Ages of 18 or older.
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Patients receive liver transplantation due to benign end stage liver disease.
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Patients or legal agent must be able to give informed consent.
Exclusion Criteria:
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Second or combined organ transplant recipient.
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Combined transplantations such as simultaneous liver/kidney transplants
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Malignant disease.
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Uncontrol bacterial, fungal, viral or parasitic infection.
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Withdraw or unable to finish the follow-up.
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Unwilling to sign informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Third Affiliated Hospital,Sun Yat-sen University | Guangzhou | Guangdong | China | 510630 |
Sponsors and Collaborators
- Third Affiliated Hospital, Sun Yat-Sen University
Investigators
- Study Chair: Yang Yang, Third Affiliated Hospital, Sun Yat-Sen University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2015-08