Confirmatory Study of NeoCart in Knee Cartilage Repair

March 27, 2019 updated by: Histogenics Corporation

A Randomized Comparison of NeoCart to Microfracture for the Repair of Articular Cartilage Injuries in the Knee

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

245

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Repair cartilage structure as measured by magnetic resonance imaging (MRI)
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Histogenics Corporation

Investigators

  • Study Director: Andrea Belschner, Histogenics Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

February 8, 2010

First Submitted That Met QC Criteria

February 9, 2010

First Posted (Estimate)

February 10, 2010

Study Record Updates

Last Update Posted (Actual)

March 29, 2019

Last Update Submitted That Met QC Criteria

March 27, 2019

Last Verified

December 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 8-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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