Clinical trial • Phase I • Infectious Disease
Conditioned medium from a co-culture of M2-macrophages and fat-derived mesenchymal cells for Acute respiratory distress syndrome (ARDS) | SARS-CoV-2 infection | Influenza A infection | Influenza B infection | Respiratory syncytial virus (RSV) infection
Phase I trial of Conditioned medium from a co-culture of M2-macrophages and fat-derived mesenchymal cells for Acute respiratory distress syndrome (ARDS) |…
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Acute respiratory distress syndrome (ARDS) | SARS-CoV-2 infection | Influenza A infection | Influenza B infection | Respiratory syncytial virus (RSV) infection
- Trial Stage
- Phase I
- Drug Modality
- Other
Key dates
- Initial CTIS Submission Date
- 12-10-2023
- First CTIS Authorization Date
- 22-01-2024
Trial design
Randomised, placebo control (placebo), dose and schedule not specified Phase I trial across 3 sites in Spain.
- Randomised
- Yes
- Comparator
- Placebo control (placebo), dose and schedule not specified
- Target Sample Size
- 50
Eligibility
Recruits 50 Vulnerable population selected (isVulnerablePopulationSelected = true); no details on consent or assent handling are provided in the record..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true); no details on consent or assent handling are provided in the record.
Recruitment
- Planned Sample Size
- 50
- Recruitment Window Months
- 41
Geography
- Total Number Of Sites
- 3
- Total Number Of Participants
- 50
Spain
- Earliest CTIS Part Ii Submission Date
- 30-08-2023
- Latest Decision Or Authorization Date
- 13-05-2026
- Processing Time Days
- 987
- Number Of Sites
- 3
- Number Of Participants
- 50
Sites
- Site Name
- Hospital Universitario De Fuenlabrada
- Department Name
- Medicina Interna
- Principal Investigator Name
- David Bernal Bello
- Principal Investigator Email
- david.bernal@salud.madrid.org
- Contact Person Name
- David Bernal Bello
- Contact Person Email
- david.bernal@salud.madrid.org
- Site Name
- Hospital Universitario Reina Sofia
- Department Name
- Servicio Enfermedades Infecciosas
- Principal Investigator Name
- Ángela María Cano Yuste
- Principal Investigator Email
- cayuam@hotmail.com
- Contact Person Name
- Ángela María Cano Yuste
- Contact Person Email
- cayuam@hotmail.com
- Site Name
- Hospital Universitario Principe De Asturias
- Department Name
- Medicina Interna
- Principal Investigator Name
- José Sanz Moreno
- Principal Investigator Email
- jsmoreno@salud.madrid.org
- Contact Person Name
- José Sanz Moreno
- Contact Person Email
- jsmoreno@salud.madrid.org
Sponsor
Primary sponsor
- Full Name
- Peaches Biotech S.L.
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- PRS CK STORM
- Active Substance
- Conditioned medium from a co-culture of M2-macrophages and fat-derived mesenchymal cells
- Modality
- Other
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