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
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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