Clinical trial • Musculoskeletal

Allogeneic bone marrow-derived mesenchymal stem cells for Knee osteoarthritis

Clinical trial of Allogeneic bone marrow-derived mesenchymal stem cells for Knee osteoarthritis. Randomised. 112 participants.

Overview

Trial Therapeutic Area
Musculoskeletal
Trial Disease
Knee osteoarthritis
Drug Modality
Cell therapy

Key dates

Initial CTIS Submission Date
31-03-2025
First CTIS Authorization Date
14-07-2025

Trial design

Randomised trial across 1 site in Denmark.

Randomised
Yes
Target Sample Size
112

Eligibility

Recruits 112 Vulnerable population not selected; no consent or assent information provided in the available records..

Vulnerable Population
Vulnerable population not selected; no consent or assent information provided in the available records.

Recruitment

Planned Sample Size
112
Recruitment Window Months
23

Geography

Total Number Of Sites
1
Total Number Of Participants
112

Denmark

Earliest CTIS Part Ii Submission Date
04-07-2025
Latest Decision Or Authorization Date
14-07-2025
Processing Time Days
10
Number Of Sites
1
Number Of Participants
112

Sites

Site Name
Næstved Hospital
Department Name
Orthopaedic Surgery and Traumatology
Principal Investigator Name
Chris Dreyer
Principal Investigator Email
cdreyer@health.sdu.dk
Contact Person Name
Chris Dreyer
Contact Person Email
cdreyer@health.sdu.dk
Number Of Participants
112

Sponsor

Primary sponsor

Full Name
Odense University Hospital
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Denmark

Investigational products

Investigational Product Name
Allogenic Ex-vivo Expanded Bone Marrow Derived Mesenchymal Stem Cells
Active Substance
Allogeneic bone marrow-derived mesenchymal stem cells
Modality
Cell therapy

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