Clinical trial • Phase III • Other
Mesenchymal stem cells for Stress urinary incontinence | Mixed urinary incontinence
Phase III trial of Mesenchymal stem cells for Stress urinary incontinence | Mixed urinary incontinence. 60 participants.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Stress urinary incontinence | Mixed urinary incontinence
- Trial Stage
- Phase III
- Drug Modality
- Cell therapy
Key dates
- Initial CTIS Submission Date
- 13-06-2024
- First CTIS Authorization Date
- 07-10-2024
Trial design
Phase III trial across 6 sites in Spain.
- Target Sample Size
- 60
Recruitment
- Planned Sample Size
- 60
- Recruitment Window Months
- 12
Geography
- Total Number Of Sites
- 6
- Total Number Of Participants
- 60
Spain
- Earliest CTIS Part Ii Submission Date
- 20-06-2024
- Latest Decision Or Authorization Date
- 01-09-2025
- Processing Time Days
- 438
- Number Of Sites
- 6
- Number Of Participants
- 60
Sites
- Site Name
- Hospital Universitario General De Villalba
- Department Name
- Urologia
- Principal Investigator Name
- Santiago Alonso Bartolomé
- Principal Investigator Email
- santiab93@gmail.com
- Contact Person Name
- Santiago Alonso Bartolomé
- Contact Person Email
- santiab93@gmail.com
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Urologia
- Principal Investigator Name
- Carmen González Enguita
- Principal Investigator Email
- cenguita@fjd
- Contact Person Name
- Carmen González Enguita
- Contact Person Email
- cenguita@fjd
- Site Name
- Hospital Universitario Del Henares
- Department Name
- Urologia
- Principal Investigator Name
- Manuel Fernandez Arjona
- Principal Investigator Email
- manuelfernandezarjona10@gmail.com
- Contact Person Name
- Manuel Fernandez Arjona
- Contact Person Email
- manuelfernandezarjona10@gmail.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Urologia
- Principal Investigator Name
- Jose Medina Polo
- Principal Investigator Email
- jose.medina@salud.madrid.org
- Contact Person Name
- Jose Medina Polo
- Contact Person Email
- jose.medina@salud.madrid.org
- Site Name
- Hospital Universitario Infanta Elena
- Department Name
- Urologia
- Principal Investigator Name
- Eduardo Useros
- Principal Investigator Email
- eduardo.useros@quironsalud.es
- Contact Person Name
- Eduardo Useros
- Contact Person Email
- eduardo.useros@quironsalud.es
- Site Name
- Hospital Universitario Rey Juan Carlos
- Department Name
- Urologia
- Principal Investigator Name
- Miguel Sánchez Encinas
- Principal Investigator Email
- miguel.sencinas@quironsalud.es
- Contact Person Name
- Miguel Sánchez Encinas
- Contact Person Email
- miguel.sencinas@quironsalud.es
Sponsor
Primary sponsor
- Full Name
- Instituto De Investigacion Sanitaria Fundacion Jimenez Diaz
- Organisation Type
- Laboratory/Research/Testing facility
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- Mesenchymal stem cells
- Active Substance
- Mesenchymal stem cells
- Modality
- Cell therapy
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