Confirmatory Study of NeoCart in Knee Cartilage Repair

Articular Cartilage Defects in the Knee Joint Clinical Trial

Official title:

A Randomized Comparison of NeoCart to Microfracture for the Repair of Articular Cartilage Injuries in the Knee

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01066702
• Other study ID #: 8-01
• Status: Terminated
• Phase: Phase 3
• Start date: May 2010
• Est. completion date: March 2019

Study information

• Verified date: December 2018
• Source: Histogenics Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 245
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Articular Cartilage Defects in the Knee Joint
• Cartilage Diseases

Intervention

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.

Locations

Country	Name	City	State
Canada	Fowler Kennedy Sports Medicine Clinic	London	Ontario
Canada	Simon Fraser Orthopaedic Fund	New Westminster	British Columbia
United States	University of New Mexico	Albuquerque	New Mexico
United States	TRIA Orthopaedic Center	Bloomington	Minnesota
United States	St. Lukes Medical Center	Boise	Idaho
United States	Colorado University Boulder	Boulder	Colorado
United States	Alpine Orthopedics & Sports Medicine	Bozeman	Montana
United States	Rush University Medical Center	Chicago	Illinois
United States	Ohio State University - Department of Sports Medicine	Columbus	Ohio
United States	Steadman Hawkins Clinic - Denver	Denver	Colorado
United States	Duke Sports Medicine	Durham	North Carolina
United States	Shrock Clinical Research	Fort Lauderdale	Florida
United States	OrthoIndy	Greenwood	Indiana
United States	Grossmont Orthopedic Medical Group	La Mesa	California
United States	The Orthopedic Specialty Hospital	Murray	Utah
United States	Ochsner Clinic Sports Medicine	New Orleans	Louisiana
United States	Hospital for Special Surgery	New York	New York
United States	Orthopaedic Specialty Institute/Newport Orthopedic Institute (OSI/NOI)	Orange	California
United States	Jewett Orthopaedic Clinic	Orlando	Florida
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon
United States	Orthopaedic Associates	Portland	Maine
United States	Mayo Clinic	Rochester	Minnesota
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	The San Antonio Orthopaedic Group (TSAOG)	San Antonio	Texas
United States	UCSF Mission Bay Orthopaedic Institute	San Francisco	California
United States	Optim Healthcare	Savannah	Georgia
United States	University of Washington	Seattle	Washington
United States	Tucson Orthopaedic Institute	Tucson	Arizona
United States	Southern California Orthopedic Research and Education	Van Nuys	California
United States	Harvard Vanguard Medical Associates	West Roxbury	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Histogenics Corporation

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (2)

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. doi: 10.2106/JBJS.K.00533. — View Citation

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. doi: 10.1177/0363546509333011. Epub 2009 May 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		one year
Secondary	Repair cartilage structure as measured by magnetic resonance imaging (MRI)		one year

External Links

•   Histogenics WebSite