NCT06549686 A Phase III Study of CLS2901C in Patients With Osteoarthritis of the Knee
| NCT ID | NCT06549686 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | CellSeed Inc. |
| Condition | Osteoarthritis of the Knee |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2023-10-20 |
| Primary Completion | 2027-07-31 |
Trial Parameters
Eligibility Fast-Check
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Brief 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, \<=5 degree extension 4. Preoperative cartilage defect of the femoral condyle/trochlear groove or medial tibial condyle with an area of \>=4 cm2 per defect site. 5. Total defect area of \<=21 cm2 in individuals with multiple cartilage defects. 6. Body mass index (BMI) \<30. 7. No coexisting ligament injury requiring surgery, and no meniscal injury requiring suturing or surgical repair other than partial resection, in the target knee. 8. No history of ligament reconstruction, meniscal suturing, total meniscectomy or bone marrow stimulation, and no history of treatment with regenerative medicine products (including investigational products), cell processing products or gene therap