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Confirmatory Study of NeoCart in Knee Cartilage Repair

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ClinicalTrials.gov Identifier: NCT01066702
Recruitment Status : Active, not recruiting
First Posted : February 10, 2010
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
Histogenics Corporation

Study Description
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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 Design
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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 : June 2020
Estimated Study Completion Date : June 2020
Arms and Interventions
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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.


Outcome Measures
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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 ]

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

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01066702


  Show 31 Study Locations
Sponsors and Collaborators
Histogenics Corporation
Investigators
Study Director: Andrea Belschner Histogenics Corporation
More Information
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Additional Information:
Histogenics WebSite  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Histogenics Corporation
ClinicalTrials.gov Identifier: NCT01066702     History of Changes
Other Study ID Numbers: 8-01
First Posted: February 10, 2010    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018

Additional relevant MeSH terms:
Cartilage Diseases
Musculoskeletal Diseases
Connective Tissue Diseases