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NeoCart Phase 2 Clinical Trial

This study has been completed.
Information provided by (Responsible Party):
Histogenics Corporation Identifier:
First received: October 19, 2007
Last updated: March 25, 2014
Last verified: March 2014
The objective of this study is to gather additional information regarding the performance of NeoCart to fill articular cartilage defects in the knee.

Condition Intervention Phase
Articular Cartilage Damage Biological: NeoCart Procedure: microfracture Phase 2

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

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

Enrollment: 30
Study Start Date: December 2006
Study Completion Date: March 2014
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NeoCart Biological: NeoCart
autologous tissue implant
Active Comparator: microfracture Procedure: microfracture


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.
  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 identifier: 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
  More Information

Responsible Party: Histogenics Corporation Identifier: NCT00548119     History of Changes
Other Study ID Numbers: 6-01
Study First Received: October 19, 2007
Last Updated: March 25, 2014 processed this record on September 21, 2017