A randomized, double blind trial comparing CARTISTEM to surgical debridement for the treatment of focal cartilage defects in patients with early-stage knee osteoarthritis, conducted across up to 80 sites in the United States and Canada.
Multi-site industry-sponsored trial (N≈300)
Randomized, prospective, double blind controlled trial
Patients ages 18 to 75 with a BMI of 35 or under, diagnosed with knee osteoarthritis, who have failed at least 3 months of conservative treatment. Candidates must have a Kellgren Lawrence grade of 2 to 3, a specific range of femoral cartilage defect size, and pain and function scores within defined ranges. Full screening and baseline eligibility criteria apply, including limits on recent injections, other joint conditions, and certain medical histories.
To compare pain and functional outcomes between CARTISTEM and standard surgical debridement over a two year period in patients with a focal cartilage defect and early-stage knee osteoarthritis.
Patients are screened with X-ray, MRI, labs, and questionnaires, then complete a baseline patient-reported outcome visit within 10 days of surgery. On surgery day, half of the participants receive CARTISTEM and half receive debridement only. Patients complete a daily symptom diary between screening and their baseline visit, then again for the 7 days preceding each follow-up visit.
Each follow-up visit includes a physical exam, knee evaluation, medication check, patient-reported outcomes, labs, and diary review.