Confirmatory Study of NeoCart in Knee Cartilage Repair
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ClinicalTrials.gov Identifier: NCT01066702 |
Recruitment Status :
Terminated
(company dissolution)
First Posted : February 10, 2010
Last Update Posted : March 29, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Articular Cartilage Defects in the Knee Joint | Biological: NeoCart Procedure: Microfracture | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 245 participants |
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 |
Study Start Date : | May 2010 |
Actual Primary Completion Date : | March 2019 |
Actual Study Completion Date : | March 2019 |
Arm | Intervention/treatment |
---|---|
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. |
- 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 ]
- Repair cartilage structure as measured by magnetic resonance imaging (MRI) [ Time Frame: one year ]

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Ages Eligible for Study: | 18 Years to 59 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01066702

Study Director: | Andrea Belschner | Histogenics Corporation |
Publications:
Responsible Party: | Histogenics Corporation |
ClinicalTrials.gov Identifier: | NCT01066702 |
Other Study ID Numbers: |
8-01 |
First Posted: | February 10, 2010 Key Record Dates |
Last Update Posted: | March 29, 2019 |
Last Verified: | December 2018 |