NeoCart Phase 2 Clinical Trial - Full Text View

NeoCart Phase 2 Clinical Trial

This study is currently recruiting participants.
Verified by Histogenics Corporation, December 2007

Sponsored by:	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	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment

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 ]

Estimated Enrollment:	30
Study Start Date:	December 2006
Estimated Study Completion Date:	January 2008

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

Contacts


Contact: Theresa G Wingrove, PhD	781-547-7900	twingrove@histogenics.com

Locations


United States, California
	UCSF	Recruiting
	San Francisco, California, United States, 94143
	Principal Investigator: Benjamin C. Ma, MD

United States, Oregon
	OHSU	Recruiting
	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

Responsible Party:	Histogenics ( Theresa G. Wingrove, PhD, VP of Regulatory and Clinical Affairs )
Study ID Numbers:	6-01
First Received:	October 19, 2007
Last Updated:	December 17, 2007
ClinicalTrials.gov Identifier:	NCT00548119
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 17, 2008