Clinical trial • Phase III • Musculoskeletal
Mesenchymal stromal cells for Post-operative recovery after hip fracture surgery
Phase III trial of Mesenchymal stromal cells for Post-operative recovery after hip fracture surgery. 10 participants.
Overview
- Trial Therapeutic Area
- Musculoskeletal
- Trial Disease
- Post-operative recovery after hip fracture surgery
- Trial Stage
- Phase III
- Drug Modality
- Cell therapy
Key dates
- Initial CTIS Submission Date
- 20-12-2024
- First CTIS Authorization Date
- 05-05-2025
Trial design
Phase III trial across 1 site in Sweden.
- Target Sample Size
- 10
Eligibility
Recruits 10 Population described as frail elderly patients; 'isVulnerablePopulationSelected' is false in the record. No consent or assent handling details are provided in the available data..
- Vulnerable Population
- Population described as frail elderly patients; 'isVulnerablePopulationSelected' is false in the record. No consent or assent handling details are provided in the available data.
Recruitment
- Planned Sample Size
- 10
- Recruitment Window Months
- 36
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 10
Sweden
- Earliest CTIS Part Ii Submission Date
- 28-02-2025
- Latest Decision Or Authorization Date
- 04-08-2025
- Processing Time Days
- 157
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- Karolinska University Hospital
- Department Name
- Clintec
- Contact Person Name
- Margareta Hedström
- Contact Person Email
- margareta.hedstrom@regionstockholm.se
- Number Of Participants
- 10
Sponsor
Primary sponsor
- Full Name
- Karolinska University Hospital
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- Mesenchymal stromal cell therapy
- Active Substance
- Mesenchymal stromal cells
- Modality
- Cell therapy
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