Confirmatory Study of NeoCart in Knee Cartilage Repair

This study is currently recruiting participants.
Verified March 2014 by Histogenics Corporation
Sponsor:
Information provided by (Responsible Party):
Histogenics Corporation
ClinicalTrials.gov Identifier:
NCT01066702
First received: February 8, 2010
Last updated: March 25, 2014
Last verified: March 2014

February 8, 2010
March 25, 2014
May 2010
July 2015   (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
July 2017
July 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • symptomatic articular cartilage lesion of the femur

Exclusion Criteria:

  • prior surgical intervention other than debridement
Both
18 Years to 55 Years
No
Contact: Nancy M Lynch, MD 1-855-963-6227 NeoCartContactCenter@UBC.com
United States
 
NCT01066702
8-01
Yes
Histogenics Corporation
Histogenics Corporation
Not Provided
Study Director: Nancy M Lynch, MD Histogenics Corporation
Histogenics Corporation
March 2014

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