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Sponsored by: |
Histogenics Corporation |
Information provided by: | Histogenics Corporation |
ClinicalTrials.gov Identifier: | NCT00548119 |
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 |
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 |
Estimated Enrollment: | 30 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | January 2008 |
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Theresa G Wingrove, PhD | 781-547-7900 | twingrove@histogenics.com |
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 |
Histogenics Corporation |
Principal Investigator: | Benjamin Ma, MD | University of California, San Francisco |
Principal Investigator: | Dennis Crawford, MD | Oregon Health and Science University |
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 |