Cartilage damage can be caused by athletic activity, traumatic injury, and even daily wear and tear. Symptoms of an injury can include aching, pain, swelling, locking, catching or giving way of the knee.
Made from a patient’s own cells, NeoCart® is an investigational cartilage tissue implant to treat certain knee cartilage injuries. The proprietary procedure uses regenerative medicine technology to create hyaline-like cartilage tissue from a patient’s own cells. The NeoCart® investigational study is intended to determine if NeoCart® may potentially result in durable, long-lasting patient response.
To generate the NeoCart® cartilage tissue implant, a surgeon first obtains a small sample of normal cartilage from a patient’s knee through a minimally invasive arthroscopy, or “knee scope.” This small tissue sample, or biopsy, is then treated and placed under special conditions that allow for cell growth, organization and tissue formation. This allows the patient’s own cells to form a hyaline-like cartilage tissue implant before being returned to the surgeon for implantation. The implant can be trimmed so that it fits the injury site (like a puzzle piece).
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.
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.
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.