NeoCart Phase 2 Clinical Trial
Phase 2
Completed
- Conditions
- Articular Cartilage Damage
- Interventions
- Biological: NeoCartProcedure: microfracture
- Registration Number
- NCT00548119
- Lead Sponsor
- Histogenics Corporation
- Brief Summary
The objective of this study is to gather additional information regarding the performance of NeoCart to fill articular cartilage defects in the knee.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NeoCart NeoCart - microfracture microfracture -
- Primary Outcome Measures
Name Time Method The safety and preliminary efficacy of NeoCart will be compared to conventional microfracture therapy. One year
- Secondary Outcome Measures
Name Time Method This study will extend the experience derived from our Phase 1 study. One year
Trial Locations
- Locations (6)
TRIA Orthopedic Center
🇺🇸Bloomington, Minnesota, United States
UCSF
🇺🇸San Francisco, California, United States
Hospital for Special Surgery
🇺🇸New York, New York, United States
Duke Sports Medicine Center
🇺🇸Durham, North Carolina, United States
OHSU
🇺🇸Portland, Oregon, United States
Keller Army Community Hospital
🇺🇸West Point, New York, United States