Confirmatory Study of NeoCart in Knee Cartilage Repair
This study is ongoing, but not recruiting participants.
Sponsor:
Histogenics Corporation
Information provided by (Responsible Party):
Histogenics Corporation
ClinicalTrials.gov Identifier:
NCT01066702
First received: February 8, 2010
Last updated: March 25, 2013
Last verified: March 2013
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Purpose
This confirmatory study is a prospective randomized trial comparing the efficacy and safety of an autologous chondrocyte tissue implant (NeoCart) to the surgical intervention microfracture in the treatment of cartilage defects in the knee.
| Condition | Intervention | Phase |
|---|---|---|
|
Cartilage Defects of the Femoral Condyle |
Biological: NeoCart Procedure: Microfracture |
Phase 3 |
| 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 change of physical functioning and pain as assessed by patient reported outcome measures (Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC) score) [ Time Frame: one year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Repair cartilage structure as measured by magnetic resonance imaging (MRI) [ Time Frame: one year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 245 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | July 2017 |
| Estimated Primary Completion Date: | July 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: NeoCart
Autologous cartilagenous tissue implant
|
Biological: NeoCart
implantation of an cartilagenous tissue implant derived from the patients own cells.
|
|
Active Comparator: Microfracture
surgical intervention
|
Procedure: Microfracture
holes are created in bone at the base of the defect bed to encourage growth of tissue within the defect bed.
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- symptomatic articular cartilage lesion of the femur
Exclusion Criteria:
- prior surgical intervention other than debridement
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01066702
Locations
| United States, Arizona | |
| Tucson Orthopaedic Institute | |
| Tucson, Arizona, United States, 85712 | |
| United States, California | |
| UCSF Mission Bay Orthopaedic Institute | |
| San Francisco, California, United States, 94158 | |
| United States, Colorado | |
| University of Colorado | |
| Boulder, Colorado, United States, 80304 | |
| United States, Florida | |
| Sunrise Medical Research | |
| Lauderdale Lakes, Florida, United States, 33319 | |
| United States, Georgia | |
| Optim Healthcare | |
| Savannah, Georgia, United States, 31405 | |
| United States, Louisiana | |
| Ochsner Clinic Sports Medicine | |
| New Orleans, Louisiana, United States, 70121 | |
| United States, Maryland | |
| Rubin Institute for Advanced Orthopedics Sinai Hospital of Balitmore | |
| Baltimore, Maryland, United States, 21215 | |
| United States, New Mexico | |
| University of New Mexico | |
| Albuquerque, New Mexico, United States, 87131 | |
| 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, 10996 | |
| United States, North Carolina | |
| Duke Sports Medicine | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Cleveland Clinic | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Oregon | |
| Oregon Health & Science University | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
Sponsors and Collaborators
Histogenics Corporation
More Information
Publications:
| Responsible Party: | Histogenics Corporation |
| ClinicalTrials.gov Identifier: | NCT01066702 History of Changes |
| Other Study ID Numbers: | 8-01 |
| Study First Received: | February 8, 2010 |
| Last Updated: | March 25, 2013 |
| Health Authority: | United States: Food and Drug Administration |
ClinicalTrials.gov processed this record on May 19, 2013