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NCT06549686
A Phase III Study of CLS2901C in Patients With Osteoarthritis of the Knee
Conditions: Osteoarthritis of the Knee
Sex: All
Ages: 20 Years – 79 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 96
Sponsor: CellSeed Inc.
Location: Ebina General Hospital/Ebina Medical Plaza Ebina Kanagawa
Summary
To evaluate the efficacy and safety of CLS2901C human allogenic chondrocyte sheets used in the osteotomy + RMSC group compared to in the osteotomy alone group of patients with osteoarthritis of the knee (OAK).
Eligibility Criteria
Inclusion Criteria:
1. Male or female aged 20 to 79 years at informed consent.
2. Diagnosis of OAK classified as Kellgren-Lawrence (K-L) Grade 2 to 4 based on plain lower extremity X-ray.
3. OAK eligible for proximal tibial osteotomy based on the following criteria: Range of motion (ROM): \>=120 degree flexion, \=4 cm2 per defect site.
5. Total defect area of \
Source: ClinicalTrials.gov (NCT06549686). StuddyBuddy aggregates publicly available trial information.
