Clinical trial • Phase III • Musculoskeletal
PLX-PAD cells for Osteoarthritis | Knee osteoarthritis
Phase III trial of PLX-PAD cells for Osteoarthritis | Knee osteoarthritis. Randomised, none/not specified-controlled. 18 participants.
Overview
- Trial Therapeutic Area
- Musculoskeletal
- Trial Disease
- Osteoarthritis | Knee osteoarthritis
- Trial Stage
- Phase III
- Drug Modality
- Cell therapy
Key dates
- Initial CTIS Submission Date
- 05-03-2025
- First CTIS Authorization Date
- 30-05-2025
Trial design
Randomised, none/not specified-controlled Phase III trial across 1 site in Germany.
- Randomised
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 18
Eligibility
Recruits 18 Vulnerable population not selected; no special consent or assent handling mentioned..
- Vulnerable Population
- Vulnerable population not selected; no special consent or assent handling mentioned.
Recruitment
- Planned Sample Size
- 18
- Recruitment Window Months
- 19
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 18
Germany
- Earliest CTIS Part Ii Submission Date
- 05-05-2025
- Latest Decision Or Authorization Date
- 08-05-2026
- Processing Time Days
- 368
- Number Of Sites
- 1
- Number Of Participants
- 18
Sites
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Centrum für Muskuloskeletale Chirurgie
- Contact Person Name
- Stephan Oehme
- Contact Person Email
- stephan.oehme@charite.de
Sponsor
Primary sponsor
- Full Name
- Charite Universitaetsmedizin Berlin KöR
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- PLX-PAD cells
- Active Substance
- PLX-PAD cells
- Modality
- Cell therapy
- Routes Of Administration
- Intra-articular injection
- Route
- Intra-articular
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