An interventional study of Lymphapheresis in Kidney Transplantation and Liver Transplantation, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown at 2 sites in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-03-28.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Other
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 findings indicate that CD4+ FOXP3 expressing regulatory T (Treg) cells play a central role in the induction of tolerance to the grafts indicating that the use of Treg cells may be an innovative therapeutic strategy in kidney transplantation that would enable the diminution of immunosuppressive drugs or even their discontinuation, thus decreasing their risk of adverse events.
As human Treg cells represent less than 10% of CD4+ T cells, and because it has been shown in mice that a dose of 2*104 polyclonal Tregs/g was necessary to induce tolerance in animal models of solid organ transplantation, it is mandatory to expand human Treg cells ex vivo, after isolating them from peripheral blood. The investigators previously defined a protocol for Treg cell isolation and expansion in clinical grade conditions (cGMP) that enabled us to obtain the expected number of expanded cells maintaining high levels of FOXP3 (3).
The investigators therefore hypothesize in humans, as it has been already shown in mice, that the infusion of autologous expanded polyclonal Treg cells would lead to the obtaining of operational tolerance in kidney and liver graft in association with classical immunosuppressants and an expectable diminution of those.
To this end, it is necessary to have pre-clinical batches of expanded Treg cells validated by the National Agency for Medicines and Health Products Safety validate (ANSM). The investigators therefore plan to have 4 batches from 2 liver transplant patients and 2 kidney transplant patients validated.
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,578 studies on the registry; 1,030 are open to participants now.
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For liver transplant patients:
For kidney transplant patients:
Common criteria:
Exclusion Criteria:
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:
Blood is drawn from one of the patient's two arms and passes through a separation circuit. After removing the white blood cells, it is reinjected into the other arm.
Other: Lymphapheresis
\- From the blood product of lymphapheresis: Autologous naïve regulatory CD45RA+CD4+CD25+FoxP3+ T lymphocytes (Tregs) selected and amplified ex vivo; obtained by selection and sorting of CD4+CD25 +CD127lowCD45RA+ cells, derived from lymphapheresis and amplified ex vivo for 10 +/- 1 days, under cGMP condition in the presence of IL2 and Rapamycin
Validate 4 preclinical batches of Treg cells from 2 liver transplant patients and 2 kidney transplant patients
Treg cells produced according to the expansion protocol defined by verifying the compliance of the batches according to the requirements of the guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Product) by respecting the validation and batch release criteria defined in this protocol.
Time frame: At day 10
Start is estimated for Apr 2023; primary completion for Apr 2024, 12 months later.
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This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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