The study aim to evaluate safety of exosomes (sEVs) from allogeneic mesenchymal stromal cells delivered by an intra-articular injection in the knee of patients with mild to moderate symptomatic osteoarthritis. The sEVs will be produced in a GMP-facility. We expect to enrolle 10 patients in this phase 1 trial and the follow-up will be up to 12 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Exosomes 3-5x10e11 particles/dose
Adverse Event
Ocurrence of any adverse reactions within 12 months of treatment
Time frame: 12 months
Incidence of injection-related pain according to VAS scale (0-100mm)
Pain measured by VAS scale after first week of treatment
Time frame: 1 week
Incidence of injection-related sinovitis according to effusion grading scale of knee joint
Synovitis measured by effusion grading scale (zero to 3+) after first week of treatment
Time frame: 1 week
Pain reduction
Change in VAS score after 52 weeks
Time frame: 52 weeks
Disability reduction
Change in Womac subscale related to function (C) after 52 weeks
Time frame: 52 weeks
Percentage of responders
According to OMERACT-OARSI Criteria Index Response after 52 weeks
Time frame: 52 weeks
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