Ignite Creation Date:
2024-05-06 @ 3:31 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04661254
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-03-28
First Post:
2020-12-03
Brief Title:
Treg Cell Therapy in Liver and Kidney Transplantation - Preclinical Validation of Batches of Treg Cells Amplified in Vitro
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Treg Cell Therapy in Liver and Kidney Transplantation - Preclinical Validation of Batches of Treg Cells Amplified in Vitro
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRE-TREG
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 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 2104 polyclonal Tregsg 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
As human Treg cells represent less than 10 of CD4 T cells and because it has been shown in mice that a dose of 2104 polyclonal Tregsg 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-A01871-38 | OTHER | ANSM | None |