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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

CLS2901C (human [allogeneic] chondrocyte sheets)
Biological/Vaccine
CLS2901C (human \[allogeneic\] chondrocyte sheets)

Treatment groups

96 Participants

are divided into 2 treatment groups

Group A: the osteotomy monotherapy groupNo intervention 0 interventions

Group B: the osteotomy + RMSC combination therapy groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

KOOS 4 score (The Knee injury and Osteoarthritis Outcome 4 score)

Absolute change from baseline KOOS4 (Pain, Symptoms, ADL, QOL) score at postoperative Week 52. The four patient-relevant subscales of KOOS are scored separately: KOOS Pain (9items); KOOS Symptoms (7 items); KOOS ADL (17 items); KOOS QOL (4 items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures.

Time frame

52 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CellSeed Inc.

Lead sponsor

Source ClinicalTrials.gov

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