A Phase III Study of CLS2901C in Patients With Osteoarthritis of the Knee
ConditionOsteoarthritis of the Knee
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age20-79
SponsorCellSeed Inc.
About this trial
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
Qualifiers
Male or female aged 20 to 79 years at informed consent.
Diagnosis of OAK classified as Kellgren-Lawrence (K-L) Grade 2 to 4 based on plain lower extremity X-ray.
OAK eligible for proximal tibial osteotomy based on the following criteria: Range of motion (ROM): >=120 degree flexion, <=5 degree extension
Preoperative cartilage defect of the femoral condyle/trochlear groove or medial tibial condyle with an area of >=4 cm2 per defect site.
Disqualifiers
Requires surgical treatment of the non-target knee during the study period.
Any coexisting illness that would interfere with surgery under general anesthesia or that would affect knee surgery.
Systemic inflammatory disease such as rheumatoid arthritis.
Systemic Active infectious disease such as bacterial, fungal or viral infection.
Trial design
Treatments tested in this trial
- CLS2901C (human [allogeneic] chondrocyte sheets)
Treatment groups
96 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov