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
- Contact Person Email
- annavilas.germanstrias@gencat.cat
- 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
- Contact Person Email
- francescjosep.moreso@vallhebron.cat
- 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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