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NeoCart Phase 2 Clinical Trial

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. Identifier: NCT00548119
Recruitment Status : Completed
First Posted : October 23, 2007
Last Update Posted : April 21, 2014
Information provided by (Responsible Party):
Histogenics Corporation

Brief Summary:
The objective of this study is to gather additional information regarding the performance of NeoCart to fill articular cartilage defects in the knee.

Condition or disease Intervention/treatment Phase
Articular Cartilage Damage Biological: NeoCart Procedure: microfracture Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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
Study Start Date : December 2006
Primary Completion Date : November 2009
Study Completion Date : March 2014

Arm Intervention/treatment
Experimental: NeoCart Biological: NeoCart
autologous tissue implant
Active Comparator: microfracture Procedure: microfracture

Primary Outcome Measures :
  1. The safety and preliminary efficacy of NeoCart will be compared to conventional microfracture therapy. [ Time Frame: One year ]

Secondary Outcome Measures :
  1. This study will extend the experience derived from our Phase 1 study. [ Time Frame: One year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients presenting with symptomatic knee pain indicative of an articular cartilage injury and able and willing to give informed consent.

Exclusion Criteria:

  • Patients with any previous surgical treatment other than debridement or microfracture of the study cartilage defect.

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 identifier (NCT number): NCT00548119

United States, California
San Francisco, California, United States, 94143
United States, Minnesota
TRIA Orthopedic Center
Bloomington, Minnesota, United States
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Keller Army Community Hospital
West Point, New York, United States
United States, North Carolina
Duke Sports Medicine Center
Durham, North Carolina, United States, 27710
United States, Oregon
Portland, Oregon, United States
Sponsors and Collaborators
Histogenics Corporation

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Histogenics Corporation Identifier: NCT00548119     History of Changes
Other Study ID Numbers: 6-01
First Posted: October 23, 2007    Key Record Dates
Last Update Posted: April 21, 2014
Last Verified: March 2014