NOVOCART 3D Autologous Chondrocyte Implant System U.S. Phase 3 Clinical Trial
NOVOCART 3D Autologous Chondrocyte Transplantation System is a biologic-device combination product composed of ex vivo expanded autologous chondrocytes seeded on a bioresorbable biphasic collagen scaffold.
Within the United States, this product is investigational and not available or approved for use outside of the clinical trial. In Europe, NOVOCART 3D is an Advanced Therapy Medicinal Product and has been on the market since 2003. Within the United States, an ongoing Phase 3 clinical study compares NOVOCART 3D, a combination product (biologic/device), to Microfracture in the treatment of articular cartilage defects of the knee.
Participating patients will be randomly assigned to receive NOVOCART 3D or Microfracture.
The NOVOCART 3D biphasic scaffold consists of a collagen membrane cover attached to a cell-carrying, three-dimensional collagen scaffold. The product applies the patient’s own chondrocytes, held within the three-dimensional scaffold, which is secured directly into the defect. The use of NOVOCART 3D involves two separate surgeries. In the first surgery, a small amount of knee cartilage about the size of a pencil eraser is removed from the affected knee and sent to Aesculap Biologics’ manufacturing facility to be processed for re-implantation. During a second surgery, approximately three weeks later, the damaged area of the knee cartilage is cleaned and the sponge-like scaffold containing the autologous chondrocytes is implanted into the prepared space of the defect.
Summary of Inclusion Criteria
The following criteria must be satisfied, to participate as a patient in this clinical trial:
- Between the ages of 18 and 65 years
- BMI below 40
- Inadequate response to conservative treatment
- Cartilage defect localized at the femoral condyle or trochlea
- Defect size between 2.0 and 6.0 cm2
- Defect grade III or IV according to International Cartilage Repair Society classification
- Intact, functional meniscus (partial resection up to half of its total volume is acceptable)
- Stable knee joint or sufficiently reconstructed ligaments
- Patient is able to receive MRI imaging (for sites participating in MRI sub-study)
Exclusion Criteria
Patients are not eligible to participate in this clinical trial if one or more of the below criteria are fulfilled:
- History of surgical treatment (other than debridement) for cartilage repair in the affected knee
- Clinically significant arthritis/arthrosis (impacting pain and function of target knee)
- 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
- Osteoporosis
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.
