NeoCart Phase 2 Clinical Trial

This study is ongoing, but not recruiting participants.

First Received on October 19, 2007. Last Updated on February 1, 2010 History of Changes

Sponsor:	Histogenics Corporation
Information provided by:	Histogenics Corporation
ClinicalTrials.gov Identifier:	NCT00548119

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 II

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
Estimated Study Completion Date:	January 2013
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

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

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

Investigators

Principal Investigator:	Benjamin Ma, MD	University of California, San Francisco
Principal Investigator:	Dennis Crawford, MD	Oregon Health and Science University

More Information

No publications provided

Responsible Party:	Theresa G. Wingrove, PhD, VP of Regulatory and Clinical Affairs, Histogenics
ClinicalTrials.gov Identifier:	NCT00548119 History of Changes
Other Study ID Numbers:	6-01
Study First Received:	October 19, 2007
Last Updated:	February 1, 2010
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on February 09, 2012