Confirmatory Study of NeoCart in Knee Cartilage Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01066702
Recruitment Status : Active, not recruiting
First Posted : February 10, 2010
Last Update Posted : August 10, 2018
Information provided by (Responsible Party):
Histogenics Corporation

Brief Summary:
This confirmatory study is a prospective randomized trial comparing the efficacy and safety of an autologous chondrocyte tissue implant (NeoCart) to the surgical intervention microfracture in the treatment of cartilage defects in the knee.

Condition or disease Intervention/treatment Phase
Articular Cartilage Defects in the Knee Joint Biological: NeoCart Procedure: Microfracture Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 245 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Comparison of NeoCart to Microfracture for the Repair of Articular Cartilage Injuries in the Knee
Study Start Date : May 2010
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Experimental: NeoCart
Autologous cartilagenous tissue implant
Biological: NeoCart
implantation of an cartilagenous tissue implant derived from the patients own cells.

Active Comparator: Microfracture
surgical intervention
Procedure: Microfracture
holes are created in bone at the base of the defect bed to encourage growth of tissue within the defect bed.

Primary Outcome Measures :
  1. The change of physical functioning and pain as assessed by patient reported outcome measures (Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC) score) [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Repair cartilage structure as measured by magnetic resonance imaging (MRI) [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • greater than 18 years old
  • symptomatic articular cartilage lesion of the femur and/or trochlea

Exclusion Criteria:

  • prior surgical intervention other than debridement
  • arthritis
  • clinically significant or symptomatic vascular or neurologic disorder of the lower extremities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01066702

  Hide Study Locations
United States, Arizona
Tucson Orthopaedic Institute
Tucson, Arizona, United States, 85712
United States, California
Grossmont Orthopedic Medical Group
La Mesa, California, United States, 91942
Orthopaedic Specialty Institute/Newport Orthopedic Institute (OSI/NOI)
Orange, California, United States, 92868
UCSF Mission Bay Orthopaedic Institute
San Francisco, California, United States, 94158
Southern California Orthopedic Research and Education
Van Nuys, California, United States, 91405
United States, Colorado
Colorado University Boulder
Boulder, Colorado, United States, 80304
Steadman Hawkins Clinic - Denver
Denver, Colorado, United States, 80111
United States, Florida
Shrock Clinical Research
Fort Lauderdale, Florida, United States, 33316
Jewett Orthopaedic Clinic
Orlando, Florida, United States, 32822
United States, Georgia
Optim Healthcare
Savannah, Georgia, United States, 31405
United States, Idaho
St. Lukes Medical Center
Boise, Idaho, United States, 83702
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Indiana
Greenwood, Indiana, United States, 46143
United States, Louisiana
Ochsner Clinic Sports Medicine
New Orleans, Louisiana, United States, 70121
United States, Maine
Orthopaedic Associates
Portland, Maine, United States, 04102
United States, Massachusetts
Harvard Vanguard Medical Associates
West Roxbury, Massachusetts, United States, 02467
United States, Michigan
William Beaumont Hospital
Royal Oaks, Michigan, United States, 48073
United States, Minnesota
TRIA Orthopaedic Center
Bloomington, Minnesota, United States, 55431
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Montana
Alpine Orthopedics & Sports Medicine
Bozeman, Montana, United States, 59718
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
United States, North Carolina
Duke Sports Medicine
Durham, North Carolina, United States, 27710
United States, Ohio
Ohio State University - Department of Sports Medicine
Columbus, Ohio, United States, 43221
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
The San Antonio Orthopaedic Group (TSAOG)
San Antonio, Texas, United States, 78216
United States, Utah
The Orthopedic Specialty Hospital
Murray, Utah, United States, 84107
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Canada, British Columbia
Simon Fraser Orthopaedic Fund
New Westminster, British Columbia, Canada
Canada, Ontario
Fowler Kennedy Sports Medicine Clinic
London, Ontario, Canada
Sponsors and Collaborators
Histogenics Corporation
Study Director: Andrea Belschner Histogenics Corporation