No. Patients accepted into the study will have a 2 out of 3 chance, or a 67% chance of being treated with NeoCart® and a 1 out of 3, or 33% chance of being treated with microfracture.
The treatment group is randomly assigned for each patient at the time of arthroscopy.
NeoCart® is an investigational treatment and we do not know what our Phase 3 data will show yet.
However, NeoCart® may be different from other cartilage injury products and treatments in that it contains the patient’s own (autologous) hyaline-like cartilage tissue, which may potentially result in a durable, long-lasting patient response.
According to some sources, microfracture surgery, along with other available options, may stimulate the growth of fibrocartilage, which is believed to be less durable than hyaline cartilage.
For full information on the safety risks associated with NeoCart®, please review the safety information.
Participation in the NeoCart® trial should have minimal cost to the patient and may include the appropriate co-pay as per individual insurance coverage.
The NeoCart Clinical Trial was fully enrolled in June 2017 and is no longer enrolling patients.
As an FDA regulated clinical trial, there are specific criteria which 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 can determine whether a patient is eligible. If you are between the ages of 18 and 59 years old, are suffering from knee pain, and have been told that microfracture surgery is a treatment option, you may be eligible for this study.
Yes, NeoCart® has been studied in humans. Histogenics has successfully completed Phase 1 and Phase 2 clinical trials, in patients with grade 3 chondral injury to the knee.