Study of the Treatment of Articular Repair (STAR)

Vericel

Status and phase

Completed

Phase 4

Conditions

Articular Cartilage

Treatments

Biological: Carticel (autologous cultured chondrocyte) implantation

Study type

Interventional

Funder types

Industry

Identifiers

NCT00158613

CARTCEL 012-99

Details and patient eligibility

About

This study is a prospective, longitudinal, multi-center, within patient evaluation of patients with articular cartilage defects of the knee who have had an inadequate response to a prior non-Carticel surgical treatment. Patients who met eligibility criteria were enrolled in the study. Subsequent to implantation with Carticel patients have follow-up every 6-months up to 48-months.

Enrollment

126 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Provided written informed consent
Documented history of at least one Grade III or Grade IV defect (modified Outerbridge classification) on the medial or lateral femoral condyle or trochlea
Failed prior treatment for articular cartilage defects of the knee, e.g. inadequate response to a non- ACI surgical procedure to treat the lesion, within past 3 yrs
Patient reported overall knee condition of 5 or less on the Modified Cinn Rating System
patients must have had a cartilage defect located on the medial or lateral femoral condyle or trochlea which had an inadequate response to a prior arthroscopic or other non-Carticel surgical repair procedure

Exclusion criteria