Study of the Treatment of Articular Repair (STAR)

A Prospective, Longitudinal Within-Patient Evaluation of the Effectiveness (Durability) of Carticel® (Autologous Cultured Chondrocytes) Compared to Non-Carticel Surgical Treatment for Articular Cartilage Defects of the Knee.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00158613

Enrollment

126

Registered

2005-09-12

Start date

2000-03-31

Completion date

2005-11-30

Last updated

2021-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Articular Cartilage

Brief summary

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.

Interventions

BIOLOGICALCarticel (autologous cultured chondrocyte) implantation

Each Carticel vial of autologous cultured chondrocytes contains approximately 12 million cells implanted into the defect and secured with a periosteal flap

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

* see above

Design outcomes

Primary

Measure	Time frame
Mean change from baseline in the KOOS	Baseline, 6 month, 12 months, 24 months, 36 months, 48 months

Secondary

Measure	Time frame
Change from Baseline in the Modified Cincinnati Score	6mo, 12mo, 18mo, 24mo, 30mo, 36mo, 42mo, 48mo
Change from Baseline in the Knee injury and Osteoarthritis Outcome Score (KOOS)Which consists of five sub- categories = Pain, ADL, QOL, Symptoms, Sport	12mo, 24mo, 36mo, 48mo
Change from Baseline in the SF-36 Health Status Survey	12mo, 24mo, 36mo, 48mo

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026