Confirmatory Study of NeoCart in Knee Cartilage Repair

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Histogenics Corporation
Sponsor:
Information provided by (Responsible Party):
Histogenics Corporation
ClinicalTrials.gov Identifier:
NCT01066702
First received: February 8, 2010
Last updated: May 31, 2016
Last verified: May 2016

February 8, 2010
May 31, 2016
May 2010
June 2018   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01066702 on ClinicalTrials.gov Archive Site
Repair cartilage structure as measured by magnetic resonance imaging (MRI) [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Confirmatory Study of NeoCart in Knee Cartilage Repair
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Articular Cartilage Defects in the Knee Joint
  • Biological: NeoCart
    implantation of an cartilagenous tissue implant derived from the patients own cells.
  • Procedure: Microfracture
    holes are created in bone at the base of the defect bed to encourage growth of tissue within the defect bed.
  • Experimental: NeoCart
    Autologous cartilagenous tissue implant
    Intervention: Biological: NeoCart
  • Active Comparator: Microfracture
    surgical intervention
    Intervention: Procedure: Microfracture

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
245
June 2020
June 2018   (final data collection date for primary outcome measure)

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
Both
18 Years to 59 Years   (Adult)
No
Contact: Tiffany Sepp 1-855-552-KNEE NeoCartContact@Histogenics.com
Contact: NeoCart Website: NeoCartImplant.com
United States
 
NCT01066702
8-01
Yes
Not Provided
Not Provided
Histogenics Corporation
Histogenics Corporation
Not Provided
Study Director: Tiffany Sepp Histogenics Corporation
Histogenics Corporation
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP