Histogenics is conducting a Phase 3 clinical trial to evaluate the safety and efficacy of an investigational cartilage tissue implant, NeoCart®, compared to microfracture, the current standard of care procedure for the treatment of articular cartilage defects of the knee. The study will compare the pain and function of patients treated with NeoCart® to those treated with microfracture at 12 months post-surgery.
How does it work?
Because this is a “comparative” trial, all patients will receive treatment—either the investigational treatment, NeoCart®, or the standard of care, microfracture. The trial is “randomized,” which means that patients will be assigned either treatment randomly. Eligible patients have a 67 percent chance of receiving NeoCart® and a 33 percent chance of receiving microfracture for their knee cartilage injury. The study is not blinded, meaning the patient and the surgeon will know which treatment has been assigned.
What else do I need to know?
Because this is an FDA regulated clinical trial, specific criteria must be followed to determine who is eligible for inclusion. A patient must meet all of these criteria to be included and only a surgeon participating as an investigator in the NeoCart study can determine whether a patient is eligible. If you are between the ages of 18 and 59 years old, are suffering from pain in one knee and can provide informed consent then you may be eligible for this study. Learn more about NeoCart® and our clinical trial (http://clinicaltrials.gov). To see if you may qualify for this clinical trial, please refer to the Can I Participate page.
Caution: New Biologic. Limited by Federal law to investigational use only and is not available for sale.