NeoCart Phase 2 Clinical Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Histogenics Corporation
ClinicalTrials.gov Identifier:
NCT00548119
First received: October 19, 2007
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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

Secondary Outcome Measures:
  • This study will extend the experience derived from our Phase 1 study. [ Time Frame: One year ] [ Designated as safety issue: No ]

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
microfracture

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT00548119

Locations
United States, California
UCSF
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
OHSU
Portland, Oregon, United States
Sponsors and Collaborators
Histogenics Corporation
  More Information

No publications provided

Responsible Party: Histogenics Corporation
ClinicalTrials.gov Identifier: NCT00548119     History of Changes
Other Study ID Numbers: 6-01
Study First Received: October 19, 2007
Last Updated: March 25, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 29, 2014