Confirmatory Study of NeoCart in Knee Cartilage Repair

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Histogenics Corporation

ClinicalTrials.gov Identifier:

NCT01066702

First received: February 8, 2010

Last updated: March 25, 2013

Last verified: March 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	February 8, 2010
Last Updated Date	March 25, 2013
Start Date ^ICMJE	May 2010
Estimated Primary Completion Date	July 2015 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 9, 2010)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01066702 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 9, 2010)	Repair cartilage structure as measured by magnetic resonance imaging (MRI) [ Time Frame: one year ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Confirmatory Study of NeoCart in Knee Cartilage Repair
Official Title ^ICMJE	A Randomized Comparison of NeoCart to Microfracture for the Repair of Articular Cartilage Injuries in the Knee
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Cartilage Defects of the Femoral Condyle
Intervention ^ICMJE	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.
Study Arm (s)	Experimental: NeoCart Autologous cartilagenous tissue implant Intervention: Biological: NeoCart Active Comparator: Microfracture surgical intervention Intervention: Procedure: Microfracture
Publications *	Crawford DC, DeBerardino TM, Williams RJ 3rd. NeoCart, an autologous cartilage tissue implant, compared with microfracture for treatment of distal femoral cartilage lesions: an FDA phase-II prospective, randomized clinical trial after two years. J Bone Joint Surg Am. 2012 Jun 6;94(11):979-89. Crawford DC, Heveran CM, Cannon WD Jr, Foo LF, Potter HG. An autologous cartilage tissue implant NeoCart for treatment of grade III chondral injury to the distal femur: prospective clinical safety trial at 2 years. Am J Sports Med. 2009 Jul;37(7):1334-43. Epub 2009 May 15.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	245
Estimated Completion Date	July 2017
Estimated Primary Completion Date	July 2015 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: symptomatic articular cartilage lesion of the femur Exclusion Criteria: prior surgical intervention other than debridement
Gender	Both
Ages	18 Years to 55 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01066702
Other Study ID Numbers ^ICMJE	8-01
Has Data Monitoring Committee	Yes
Responsible Party	Histogenics Corporation
Study Sponsor ^ICMJE	Histogenics Corporation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Histogenics Corporation
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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