NOVOCART 3D Autologous Chondrocyte Implant System U.S. Phase 3 Clinical Trial
NOVOCART 3D is considered an investigational product in the United States (meaning the product has not been approved by the FDA). NOVOCART 3D has been used in a select few European countries since 2003 to treat more than 17,000 patients with damaged knee cartilage. Within the United States, patients are being asked to volunteer in a research study of the investigational biologic/device combination product, NOVOCART 3D.
The purpose of the research study is to assess the pain and physical function of the knee after one of two possible surgical treatments. Participating patients will be randomly assigned to one of two surgical procedures in a ratio of 2:1. This means patients will be slightly more likely to be randomized to NOVOCART 3D than Microfracture.
One surgical procedure in the study utilizes the NOVOCART 3D autologous chondrocyte implant system. Autologous chondrocyte implant means that each patient will receive an implant populated with their own cartilage cells.
The other procedure, called Microfracture, requires making multiple small holes in the bone at the bottom of the cartilage defect. This causes bleeding and a clot is formed in the holes. This clot enables new cells to form a repair cartilage that fills the cartilage defect. After surgery, it is important to protect this clot so that new cells can form. This is one of the current standard of care options to treat damaged knee cartilage.
It is possible that participants will have significantly improved knee function and reduced pain as a result of these procedures compared to before the surgery. However, this cannot be guaranteed.
Both surgical procedures will be followed by a course of physical rehabilitation and assessments of pain and knee function.
Summary of Inclusion criteria
The following criteria must be fulfilled to participate as a patient in this clinical trial; other criteria should be discussed with a surgeon participating in the study:
- Between the ages of 18 and 65 years
- BMI below 40
- Inadequate response to conservative treatment
- Cartilage defect in the knee
- Defect size between 2.0 and 6.0 cm2
- Stable knee joint or sufficiently reconstructed ligaments
- Able to receive MRI imaging (for sites participating in MRI sub-study)
Patients are not eligible to participate in this clinical trial if one or more of the criteria is present:
- Clinically significant arthritis/arthrosis
- Presence of an autoimmune disease
- Any disease leading to immunodeficiency or immune suppression or intake of immunosuppressive drugs
- Known infection of HIV, hepatitis B/C or syphilis
- History of cancer
- Prior surgical treatment for cartilage repair (debridement/lavage is acceptable)
NOVOCART 3D is an investigational product and not approved for use in the U.S. outside of the clinical study. The information contained in this site is not intended to promote or commercialize, directly or indirectly, unapproved products.
For more information about the clinical trial and participating surgeons, visit the NOVOCART 3D study page on www.clinicaltrials.gov.