Clinical trial • Phase III • Respiratory | Infectious Disease
Wharton's Jelly-derived umbilical cord mesenchymal stromal cells for Respiratory viral disease | COVID-19 | Influenza A | Human metapneumovirus infection | Respiratory syncytial virus infection
Phase III trial of Wharton's Jelly-derived umbilical cord mesenchymal stromal cells for Respiratory viral disease | COVID-19 | Influenza A | Human metapne…
Overview
- Trial Therapeutic Area
- Respiratory | Infectious Disease
- Trial Disease
- Respiratory viral disease | COVID-19 | Influenza A | Human metapneumovirus infection | Respiratory syncytial virus infection
- Trial Stage
- Phase III
- Drug Modality
- Cell therapy
Key dates
- Initial CTIS Submission Date
- 30-10-2024
- First CTIS Authorization Date
- 28-11-2024
Trial design
Phase III trial across 1 site in Sweden.
- Target Sample Size
- 9
Eligibility
Recruits 9 No vulnerable populations selected..
- Vulnerable Population
- No vulnerable populations selected.
Recruitment
- Planned Sample Size
- 9
- Recruitment Window Months
- 23
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 9
Sweden
- Earliest CTIS Part Ii Submission Date
- 13-11-2024
- Latest Decision Or Authorization Date
- 28-11-2024
- Processing Time Days
- 15
- Number Of Sites
- 1
- Number Of Participants
- 9
Sites
- Site Name
- Universitetssjukhuset Örebro
- Department Name
- Department of Cardiology, Respiratory medicine and Physiology, Örebro University Hospital
- Contact Person Name
- Josefin Sundh
- Contact Person Email
- josefin.sundh@regionorebrolan.se
- Number Of Participants
- 9
Sponsor
Primary sponsor
- Full Name
- NextCell Pharma AB
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- Wharton’s Jelly (WJ)-Umbilical Cord (UC) Mesenchymal Stromal Cells (ProTrans®)
- Active Substance
- Wharton's Jelly-derived umbilical cord mesenchymal stromal cells
- Modality
- Cell therapy
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