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

  Hide Study Locations
Locations
United States, California
Kerlan Jobe Orthopaedic Clinic
Los Angeles, California, United States, 90045
Naval Medical Center San Diego
San Diego, California, United States, 92134
Santa Monica Orthopedic Group
Santa Monica, California, United States, 90404
Office of Dr. Noah Weiss
Sonoma, California, United States, 95476
United States, Colorado
Denver/Vail Orthopedics
Lone Tree, Colorado, United States, 80124
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06034
United States, Georgia
Atlanta Sports Medicine & Orthopaedic Center
Atlanta, Georgia, United States, 30327
United States, Illinois
Midwest Orthopedics
Chicago, Illinois, United States, 60612
Midwest Orthopaedic Center
Peoria, Illinois, United States, 61602
United States, Indiana
Orthopaedics Indianapolis
Indianapolis, Indiana, United States, 46237
United States, Iowa
Physician's Clinic of Iowa
Cedar Rapids, Iowa, United States, 52401
United States, Kentucky
Bluegrass Orthopaedics
Lexington, Kentucky, United States, 40509
United States, Maryland
National Naval Medical Center
Bethesda, Maryland, United States, 20889
Washington Orthopedic & Knee Clinic
Clinton, Maryland, United States, 20735
United States, Massachusetts
Children's Hospital
Boston, Massachusetts, United States, 02115
Pro Sports Orthopedics
Brookline, Massachusetts, United States, 02445
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55454
United States, New York
Strong Memorial Hospital, University of Rochester
Rochester, New York, United States, 14642
Keller Army Hospital
West Point, New York, United States, 10996
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
Beaumont Bone and Joint
Beaumont, Texas, United States, 77707
Brooke Army Medical Center, Fort Sam
Houston, Texas, United States, 78234
United States, Virginia
Naval Medical Center Portsmouth
Portsmouth, Virginia, United States, 23708
Advanced Orthopedic Center
Richmond, Virginia, United States, 23294
United States, Washington
Northwest Orthopedic Specialists
Spokane, Washington, United States, 99204
Canada, British Columbia
Royal Columbian Hospital
New Westminster, British Columbia, Canada, V3L 3W7
Canada, Manitoba
St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Ontario
Fowler Kennedy Sports Medicine Clinic
London, Ontario, Canada, N6A 3K7
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 September 18, 2014