Results from Phase I and Phase II study indicate that Histogenics’ NeoCart® tissue-engineered implant is a safe, effective treatment for articular cartilage lesions through 5-year follow-up. Further, patient-reported outcomes demonstrated statistically significant improvement on virtually all pain and functional endpoints, as early as 3 to 6 months, with sustained outcomes through 5 years.
The publication analyzed magnetic resonance imaging data through 60 months from the Phase I and II clinical trials of NeoCart for the repair of articular cartilage injuries in the knee in 29 patients.
As of early 4Q16, the company has enrolled ~3/4 of 245 patients required to complete enrollment of an ongoing Phase III clinical trial for NeoCart, which is being conducted under a Special Protocol Assessment with FDA. This trial is designed to evaluate safety and efficacy as a first-line therapy for full thickness knee cartilage defects in skeletally mature adults vs. microfracture, the standard of care.
Results from Phase I and Phase II study indicate that Histogenics' NeoCart® tissue-engineered implant is a safe, effective treatment for articular cartilage lesions through 5-year follow-up. Further, patient-reported outcomes demonstrated statistically significant improvement on virtually all pain and functional endpoints, as early as 3 to 6...
Results from Phase I and Phase II study indicate that Histogenics’ NeoCart® tissue-engineered implant is a safe, effective treatment for articular cartilage lesions through 5-year follow-up. Further, patient-reported outcomes demonstrated statistically significant improvement on virtually all pain and functional endpoints, as early as 3 to 6 months, with sustained outcomes through 5 years.
The publication analyzed magnetic resonance imaging data through 60 months from the Phase I and II clinical trials of NeoCart for the repair of articular cartilage injuries in the knee in 29 patients.
As of early 4Q16, the company has enrolled ~3/4 of 245 patients required to complete enrollment of an ongoing Phase III clinical trial for NeoCart, which is being conducted under a Special Protocol Assessment with FDA. This trial is designed to evaluate safety and efficacy as a first-line therapy for full thickness knee cartilage defects in skeletally mature adults vs. microfracture, the standard of care.
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