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Study of the Treatment of Articular Repair (STAR)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00158613
First received: September 8, 2005
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Articular Cartilage
Biological: Carticel (autologous cultured chondrocyte) implantation
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Mean change from baseline in the KOOS [ Time Frame: Baseline, 6 month, 12 months, 24 months, 36 months, 48 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in the Modified Cincinnati Score [ Time Frame: 6mo, 12mo, 18mo, 24mo, 30mo, 36mo, 42mo, 48mo ] [ Designated as safety issue: No ]
  • Change from Baseline in the Knee injury and Osteoarthritis Outcome Score (KOOS)Which consists of five sub- categories = Pain, ADL, QOL, Symptoms, Sport [ Time Frame: 12mo, 24mo, 36mo, 48mo ] [ Designated as safety issue: No ]
  • Change from Baseline in the SF-36 Health Status Survey [ Time Frame: 12mo, 24mo, 36mo, 48mo ] [ Designated as safety issue: No ]

Enrollment: 126
Study Start Date: March 2000
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Carticel (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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158613

  Show 28 Study Locations
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

Publications:
Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00158613     History of Changes
Other Study ID Numbers: CARTCEL 012-99
Study First Received: September 8, 2005
Last Updated: February 4, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 25, 2014