A phase 1 exploratory clinical study to investigate safety, tolerance and efficacy of a single intra-articular injection of autoSTEM-OA or alloSTEM-OA in participants with mild to moderate knee osteoarthritis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Combination of autologous or allogeneic MSC(AT)s and fat
Sanos Clinic Syddanmark
Vejle, Denmark
STEM-OA safety
Number of treatment emergent adverse events (TEAEs)
Time frame: 13 weeks
Knee pain
Change in KOOS 'pain' score
Time frame: 13 weks
Number of treatment responders
Number of treatment responders according to the OMERACT-OARSI criteria
Time frame: 13 weks
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