Orthopaedic Specialty Institute and Newport Orthopedic Institute Surgeons Conducting Trial of Investigational Tissue Implant that Could Help Repair Athletes with Knee Injuries by Using the Patient’s Own Cartilage Cells
ORANGE / NEWPORT, CA – Orthopaedic Specialty Institute (OSI) and Newport Orthopedic Institute (NOI) physicians are conducting a clinical trial evaluating NeoCart®, an investigational tissue implant developed by Histogenics as a possible treatment for certain knee cartilage injuries. The cartilage-like tissue implant, NeoCart ®, is made from a patient’s own cartilage cells. OSI/NOI are one of the first to use this investigational cartilage-like tissue implant in the country.
Russell S. Petrie, M.D. and David S. Gazzaniga, M.D., orthopedic surgeons at the Newport Orthopedic Institute and Robert Grumet, M.D., orthopaedic surgeon at the Orthopaedic Specialty Institute are participating in the Phase 3 clinical trial to evaluate the safety and efficacy of NeoCart®. The study will compare the pain and function of patients treated with NeoCart® to those treated with microfracture, the current standard-of-care procedure for the treatment of articular cartilage defects of the knee at 12 months post-surgery.
To generate the implant, a surgeon first obtains a small sample of normal cartilage from a patient’s knee through a minimally invasive knee arthroscopy. The small tissue sample is then expanded in culture into a cartilage-like tissue implant, which is returned to the injury site. Preliminary safety studies in 31 subjects using this investigational tissue implant have demonstrated that the NeoCart® cartilage implant made from patient’s own cartilage is safe with no serious side effects.
Healthy cartilage is crucial to the smooth and painless mobility of most joints, and has limited capacity to repair itself after injury. Historically, microfracture surgery is considered the current standard-of-care for most cases of moderate to severe cartilage injury in the knee. Although symptoms may improve for a period of time after surgery, microfracture doesn’t create that same healthy joint cartilage required to withstand normal forces of movement.
To qualify for the NeoCart® Clinical Trial, patients must:
- Be 18 to 59 years old
- Provide informed consent
- Suffer from pain in one knee
To learn more and find out if you may qualify for this research study, visit www.NeoCartImplant.com; call (949) 407-7951 or Text knee16 to 87888. Std. Msg. & Data rates apply
Caution: New Biologic. Limited by federal law to investigational use only and is not available for sale.
About Histogenics Corporation
Histogenics is a leading regenerative medicine company developing and commercializing products in the musculoskeletal segment of the marketplace. Histogenics’ regenerative medicine platform combines expertise in cell processing, scaffolding, tissue engineering, bioadhesives and growth factors to provide solutions to treat musculoskeletal-related conditions. Histogenics’ first investigational product candidate, NeoCart®, is currently in Phase 3 clinical development. NeoCart is an autologous cell therapy designed to treat cartilage defects in the knee using the patient’s own cells. Knee cartilage defects represent a significant opportunity in the United States, with an estimated 500,000 or more applicable procedures each year. NeoCart is designed to exhibit characteristics of articular, hyaline cartilage prior to and upon implantation into the knee and therefore does not rely on the body to make new cartilage; characteristics not exhibited in other current treatment options. For more information, please visit www.histogenics.com.