Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
126 participants
INTERVENTIONAL
2000-03-31
2005-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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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 Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Vericel Corporation
INDUSTRY
Responsible Party
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Genzyme Corporation
Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Genzyme, a Sanofi Company
Locations
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Kerlan Jobe Orthopaedic Clinic
Los Angeles, California, United States
Naval Medical Center San Diego
San Diego, California, United States
Santa Monica Orthopedic Group
Santa Monica, California, United States
Office of Dr. Noah Weiss
Sonoma, California, United States
Denver/Vail Orthopedics
Lone Tree, Colorado, United States
University of Connecticut Health Center
Farmington, Connecticut, United States
Atlanta Sports Medicine & Orthopaedic Center
Atlanta, Georgia, United States
Midwest Orthopedics
Chicago, Illinois, United States
Midwest Orthopaedic Center
Peoria, Illinois, United States
Orthopaedics Indianapolis
Indianapolis, Indiana, United States
Physician's Clinic of Iowa
Cedar Rapids, Iowa, United States
Bluegrass Orthopaedics
Lexington, Kentucky, United States
National Naval Medical Center
Bethesda, Maryland, United States
Washington Orthopedic & Knee Clinic
Clinton, Maryland, United States
Children's Hospital
Boston, Massachusetts, United States
Pro Sports Orthopedics
Brookline, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
Strong Memorial Hospital, University of Rochester
Rochester, New York, United States
Keller Army Hospital
West Point, New York, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Beaumont Bone and Joint
Beaumont, Texas, United States
Brooke Army Medical Center, Fort Sam
Houston, Texas, United States
Naval Medical Center Portsmouth
Portsmouth, Virginia, United States
Advanced Orthopedic Center
Richmond, Virginia, United States
Northwest Orthopedic Specialists
Spokane, Washington, United States
Royal Columbian Hospital
New Westminster, British Columbia, Canada
St. Boniface General Hospital
Winnipeg, Manitoba, Canada
Fowler Kennedy Sports Medicine Clinic
London, Ontario, Canada
Countries
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References
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Zaslav K, Cole B, Brewster R, DeBerardino T, Farr J, Fowler P, Nissen C; STAR Study Principal Investigators. A prospective study of autologous chondrocyte implantation in patients with failed prior treatment for articular cartilage defect of the knee: results of the Study of the Treatment of Articular Repair (STAR) clinical trial. Am J Sports Med. 2009 Jan;37(1):42-55. doi: 10.1177/0363546508322897. Epub 2008 Oct 16.
Other Identifiers
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CARTCEL 012-99
Identifier Type: -
Identifier Source: org_study_id
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