We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    neocart phase 3
Previous Study | Return to List | Next Study

Confirmatory Study of NeoCart in Knee Cartilage Repair

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01066702
First Posted: February 10, 2010
Last Update Posted: July 2, 2017
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.
Information provided by (Responsible Party):
Histogenics Corporation
  Purpose
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 Intervention Phase
Articular Cartilage Defects in the Knee Joint Biological: NeoCart Procedure: Microfracture Phase 3

Study Type: Interventional
Study Design: 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

Further study details as provided by Histogenics Corporation:

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

Enrollment: 245
Study Start Date: May 2010
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
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 35 Study Locations
Sponsors and Collaborators
Histogenics Corporation
Investigators
Study Director: Tiffany Sepp Histogenics Corporation