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Trial record 2 of 2 for:
neocart
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: June 30, 2017
Last verified: June 2017
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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 |
|---|---|---|
| Articular Cartilage Defects in the Knee Joint | Biological: NeoCart Procedure: Microfracture | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (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 ]
Secondary Outcome Measures:
- Repair cartilage structure as measured by magnetic resonance imaging (MRI) [ Time Frame: one year ]
| Enrollment: | 245 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | June 2020 |
| Estimated Primary Completion Date: | June 2018 (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 59 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- greater than 18 years old
- symptomatic articular cartilage lesion of the femur and/or trochlea
Exclusion Criteria:
- prior surgical intervention other than debridement
- arthritis
- clinically significant or symptomatic vascular or neurologic disorder of the lower extremities
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01066702
Show 35 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01066702
Show 35 Study Locations
Sponsors and Collaborators
Histogenics Corporation
Investigators
| Study Director: | Tiffany Sepp | Histogenics Corporation |
More Information
Additional 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: | June 30, 2017 |
Additional relevant MeSH terms:
|
Cartilage Diseases Musculoskeletal Diseases Connective Tissue Diseases |
ClinicalTrials.gov processed this record on September 19, 2017