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
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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