Clinical Study

Knee pain from cartilage injury can lead to increased pain and decreased function for many patients. Histogenics is conducting a clinical trial to evaluate the effectiveness of NeoCart compared to microfracture for the treatment of articular cartilage defects of the knee. The results of this study will compare the pain and function of patients treated with NeoCart to those treated with microfracture at 12 months post surgery.

The current standard of care treatment is a procedure called microfracture. This procedure involves cleaning the injured area of damaged tissue and drilling several small holes into the bone to stimulate a blood clot in the injured area.  The result of microfracture is the development of fibrocartilage at the site of treatment. This type of cartilage is less durable, less resilient and less able to withstand shock and shearing forces than native articular hyaline cartilage.

NeoCart® represents a novel approach to the treatment of symptomatic defects of the articular cartilage of the knee. Cells are obtained from the patient via a biopsy procedure during arthroscopy. The harvested cells are expanded in cell culture, embedded in a type I collagen matrix and incubated in a unique tissue processor that simulates the environment of the knee joint. The resulting product is an opalescent disc that is trimmed to fit into the injured area.  Unlike microfracture, NeoCart treatment begins with the implant of an early phase hyaline cartilaginous tissue. NeoCart Implant has been clinically tested and results from Phase I and Phase II studies have demonstrated safety of the implant and statistical significance over microfracture for pain and function¹. A Phase III clinical trial is currently being performed. The results of this confirmatory trial will be submitted to the US Food and Drug Administration for commercial approval.  Visit www.clinicaltrials.gov to see if this study is right for you.

Eligibility and Participating Centers:

Histogenics is conducting a clinical study at several medical facilities across the United States. The purpose of the study is to evaluate the effectiveness of NeoCart compared to microfracture for the treatment of articular cartilage defects of the knee. The study is a randomized clinical trial.  Patient will have a 66% chance of being randomized to NeoCart and a 33% chance of being randomized to Microfracture. Randomization will occur during the arthroscopic procedure after final eligibility is confirmed.  Following treatment, patients will adhere to a specific rehabilitation plan and will be followed for outcome results until 3 years post treatment.

Can I participate?

• If you are 18 to 55 years old and have symptomatic knee pain, this study may be right for you
• Patients who have previously failed other treatments or smoke more than one pack of cigarettes per week may not be eligible

Is there a treatment center near me?

• 25 medical centers in the United States will participate in this study
• For a list of all participating centers, visit www.clinicaltrials.gov
• Search: NeoCart
• New centers will continue to be added
• Please re-visit the website periodically for the addition of new centers

References:
^1.Crawford DC, Heveran CM, Cannon D, Foo LF, Potter HG. An autologous cartilage tissue implant NeoCart for treatment of grade III chondral injury to the distal femur. Am J Sports Med. 2009;37:1334-1343.