Confirmatory Study of NeoCart in Knee Cartilage Repair

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Histogenics Corporation
Sponsor:
Information provided by (Responsible Party):
Histogenics Corporation
ClinicalTrials.gov Identifier:
NCT01066702
First received: February 8, 2010
Last updated: September 9, 2014
Last verified: September 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Repair cartilage structure as measured by magnetic resonance imaging (MRI) [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 245
Study Start Date: May 2010
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2015 (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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • symptomatic articular cartilage lesion of the femur

Exclusion Criteria:

  • prior surgical intervention other than debridement
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01066702

Contacts
Contact: Nancy M Lynch, MD 1-855-963-6227 NeoCartContactCenter@UBC.com

  Show 28 Study Locations
Sponsors and Collaborators
Histogenics Corporation
Investigators
Study Director: Nancy M Lynch, MD Histogenics Corporation
  More Information

Additional Information:
Publications:
Responsible Party: Histogenics Corporation
ClinicalTrials.gov Identifier: NCT01066702     History of Changes
Other Study ID Numbers: 8-01
Study First Received: February 8, 2010
Last Updated: September 9, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 22, 2014