Autologous Tolerogenic Dendritic Cells (ATDC) for Highly Sensitized Kidney Transplant Recipients

Launched by FUNDACION CLINIC PER A LA RECERCA BIOMÉDICA · Feb 24, 2025

Keywords

ClinConnect Summary

The ATDC-PICI study is a clinical trial designed to investigate a new treatment called Autologous Tolerogenic Dendritic Cells (ATDC) for people who are highly sensitized and are waiting for a kidney transplant. This treatment aims to improve the chances of successful transplantation for patients who have a high level of antibodies against donor kidneys, which can make it difficult for them to receive a transplant. The study will be conducted at multiple centers and will focus on ensuring the safety of this new therapy when added to standard care practices.

To participate in this trial, candidates need to be between 18 and 65 years old and should have a very high level of sensitization (meaning their body has a strong immune response against possible donor kidneys). They must also have good access to veins for a procedure called leukoapheresis, which is necessary for this study. Participants will need to provide written consent and take contraceptive measures if they are of childbearing age. However, certain individuals, such as those with active infections, significant health issues, or who are pregnant, will not be eligible to join. If you are interested in this study, it could offer a new opportunity to improve your chances of receiving a kidney transplant.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Highly sensitized (cPRA ≥ 90%) kidney transplant candidates between 18 and 65 years old.
• • 2. To be selected by the algorithm according to probability of kidney transplantation in the upcoming 12months.
• • 3. Adequate venous access and absence of contraindications for leukoapheresis.
• • 4. Women of childbearing age must take contraceptive measures.
• • 5. Must have given written informed consent
• Exclusion Criteria:
• • 1. Subjects with active TB.
• • 2. Patients on the waiting list multiple organ transplants.
• • 3. A significantly abnormal general serum screening lab result defined as WBC\<3.0x103/ml, Hgb\<8.0 g/dL, platelet count \<100x103/ml, SGOT\>3x upper limit.
• • 4. HIV-positive subjects.
• • 5. Subjects who test positive for HBV infection \[positive HBVsAg or HBVeAg/DNA\] or HCV infection \[RNA+\].
• • 6. Subjects with active CMV or EBV infection as defined by positive PCR.
• • 7. Subjects with a known history of previous myocardial infarction within one year of screening.
• • 8. Subjects with a history of clinically significant thrombotic episodes, and subjects with active peripheral vascular disease.
• • 9. Patients with a kidney disease with high risk of recurrence and/or complement-associated kidney disease (aHUS, etc).
• • 10. Pregnant and lactating women.