Clinical trial • Phase I • Immunology
Tolerogenic dendritic cells for Type 1 diabetes
Phase I trial of Tolerogenic dendritic cells for Type 1 diabetes. None/Not specified-controlled. 10 participants.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Type 1 diabetes
- Trial Stage
- Phase I
- Drug Modality
- Cell therapy
Key dates
- Initial CTIS Submission Date
- 21-06-2024
- First CTIS Authorization Date
- 30-10-2024
Trial design
None/Not specified-controlled Phase I trial across 2 sites in Netherlands.
- Comparator
- None/Not specified
- Target Sample Size
- 10
Recruitment
- Planned Sample Size
- 10
- Recruitment Window Months
- 44
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 10
Netherlands
- Earliest CTIS Part Ii Submission Date
- 11-09-2024
- Latest Decision Or Authorization Date
- 24-03-2026
- Processing Time Days
- 559
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Diabeter Nederland B.V.
- Department Name
- Diabeter Rotterdam
- Contact Person Name
- Henk-Jan Aanstoot
- Contact Person Email
- h.j.aanstoot@diabeter.nl
- Site Name
- Academisch Ziekenhuis Leiden
- Department Name
- Hematology
- Contact Person Name
- Jaap Jan Zwaginga
- Contact Person Email
- j.j.zwaginga@lumc.nl
Sponsor
Primary sponsor
- Full Name
- Academisch Ziekenhuis Leiden
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Netherlands
Investigational products
- Investigational Product Name
- Tolerogenic dendritic cell therapy
- Active Substance
- Tolerogenic dendritic cells
- Modality
- Cell therapy
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