Status:
UNKNOWN
Treg Cell Therapy in Liver and Kidney Transplantation - Preclinical Validation of Batches of Treg Cells Amplified in Vitro
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Kidney Transplantation
Liver Transplantation
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Kidney and liver transplantation requires a fine tuning of immune responses in order to achieve long term operational tolerance with immunosuppressants or immune modulators. Numerous experimental find...
Eligibility Criteria
Inclusion
- For liver transplant patients:
- Liver transplantation carried out for 1 to 3 months for alcoholic cirrhosis;
- Normal liver biological test;
- Normal hepatic morphological assessment;
- For kidney transplant patients:
- Renal transplantation carried out for 3 to 6 months for any disease requiring renal transplantation;
- Normal renal biological assessment;
- Normal renal morphological assessment;
- DSA \<1500 MFI at inclusion
- Common criteria:
- Age ≥ 18 years and ≤ 70 years
- GB ≥1500 / mm3
- Hemoglobin level\> 10g / 100ml
- Platelets\> 50,000 / μl
- Weight\> 40Kg
- Informed and signed consent;
- Patient affiliated to a social security scheme
Exclusion
- For liver transplant patients:
- \- Hepatocellular carcinoma or history of another cancer;
- For kidney transplant patients:
- \- Kidney cancer or a history of another cancer
- Common criteria:
- Active infectious diseases: positive serology for hepatitis A, B or C, HIV, HTLV, CMV and EBV;
- Associated autoimmune disease, including type 1 diabetes;
- GB \<1500 / mm3;
- Any contraindication to citrate and calcium gluconate.
- Pregnancy or lactating woman
- Patient under guardianship or curatorship
- Patient deprived of liberty or under administrative security measure
Key Trial Info
Start Date :
April 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2024
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04661254
Start Date
April 15 2023
End Date
April 30 2024
Last Update
March 28 2023
Active Locations (2)
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1
Pitié Salpêtrière hospital
Paris, France, 75013
2
Pitié Salpêtrière hospital
Paris, France, 75013