Clinical trial • Phase III • Nephrology

Autologous tolerogenic dendritic cells for Kidney transplant

Phase III trial of Autologous tolerogenic dendritic cells for Kidney transplant. 30 participants.

Overview

Trial Therapeutic Area
Nephrology
Trial Disease
Kidney transplant
Trial Stage
Phase III
Drug Modality
Cell therapy

Key dates

Initial CTIS Submission Date
13-02-2025
First CTIS Authorization Date
16-05-2025

Trial design

Phase III trial across 7 sites in Spain.

Target Sample Size
30

Recruitment

Planned Sample Size
30
Recruitment Window Months
33

Geography

Total Number Of Sites
7
Total Number Of Participants
30

Spain

Earliest CTIS Part Ii Submission Date
16-04-2025
Latest Decision Or Authorization Date
16-04-2026
Processing Time Days
365
Number Of Sites
7
Number Of Participants
30

Sites

Site Name
Bellvitge University Hospital
Department Name
Nephrology and Renal Transplantation
Principal Investigator Name
Edoardo Melilli
Principal Investigator Email
emelilli@bellvitgehospital.cat
Contact Person Name
Edoardo Melilli
Contact Person Email
emelilli@bellvitgehospital.cat
Site Name
Hospital Clinic De Barcelona
Department Name
Nephrology and Kidney Transplantation
Principal Investigator Name
Fritz Diekmann
Principal Investigator Email
fdiekman@clinic.cat
Contact Person Name
Fritz Diekmann
Contact Person Email
fdiekman@clinic.cat
Site Name
Hospital Universitario Miguel Servet
Department Name
Nephrology
Principal Investigator Name
Alex Gutiérrez Dalmau
Principal Investigator Email
alexgutierrezd@gmail.com
Contact Person Name
Alex Gutiérrez Dalmau
Contact Person Email
alexgutierrezd@gmail.com
Site Name
Hospital Germans Trias I Pujol
Department Name
KIDNEY AND PANCREAS TRASPLANT UNIT
Principal Investigator Name
Anna Vila Santandreu
Principal Investigator Email
annavilas.germanstrias@gencat.cat
Contact Person Name
Anna Vila Santandreu
Site Name
Hospital Universitari Vall D Hebron
Department Name
Nephrology
Principal Investigator Name
Francesc Josep Moreso Mateos
Principal Investigator Email
francescjosep.moreso@vallhebron.cat
Contact Person Name
Francesc Josep Moreso Mateos
Site Name
Fundacio Puigvert
Department Name
Nephrology
Principal Investigator Name
Carme Facundo
Principal Investigator Email
cfacundo@fundacio-puigvert.es
Contact Person Name
Carme Facundo
Contact Person Email
cfacundo@fundacio-puigvert.es
Site Name
Hospital Del Mar
Department Name
Nephrology
Principal Investigator Name
Marta Crespo Barrio
Principal Investigator Email
mcrespo@psmar.cat
Contact Person Name
Marta Crespo Barrio
Contact Person Email
mcrespo@psmar.cat

Sponsor

Primary sponsor

Full Name
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
Organisation Type
Laboratory/Research/Testing facility
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
Autologous tolerogenic dendritic cells (ATDC)
Active Substance
Autologous tolerogenic dendritic cells
Modality
Cell therapy

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