SAN DIEGO, Feb. 21, 2020 /PRNewswire/ -- Dr. Scott Hacker announced today that he has treated his tenth patient in the ongoing Phase 3 clinical trial of NOVOCART 3D, an investigational autologous chondrocyte transplantation system designed to treat articular cartilage defects of the knee. Dr. Hacker serves as the primary investigator at the site, evaluating the efficacy and safety of NOVOCART 3D as compared to microfracture in the repair of articular cartilage damage of the knee.
Articular cartilage is a highly specialized tissue that covers the ends of bones in all articulating joints of the body such as the knee. Damage to cartilage through trauma can be extremely painful for patients, and the condition can be chronic due to the limited capacity for cartilage to heal. The current standard of care is surgical removal and cleaning of the defect followed by microfracture, the drilling of small holes in the bone under cartilage to form a blood clot within the defect that in turn helps promote growth of new cartilage. NOVOCART 3D offers a potential alternative to regenerate cartilage with the patient's own cells.
In the NOVOCART 3D clinical trial, a small sample of the patient's healthy cartilage tissue is harvested arthroscopically and sent to the cell manufacturing facility for processing. The cartilage cells are isolated, grown in a culture, placed onto a sponge-like device and shipped back to the surgeon for implantation into the damaged knee cartilage. Once implanted, new cartilage tissue grows and fills the damaged area, replacing the defect with the patient's own fully functional cartilage tissue.
NOVOCART 3D is approved for sale and marketing in Europe and has been implanted in over 16,000 patients since 2003, where it has been shown to provide significant clinical improvement in knee pain and function.
The multi-center, prospective, randomized, partially blinded clinical trial is the pivotal study to confirm the clinical benefit of NOVOCART 3D for its intended use in patients who have had inadequate response to conservative treatment. The results of the study will serve as the basis to bring NOVOCART 3D to the U.S. from Europe.
"We are excited that Dr. Hacker is helping to bring this innovative product to market to help patients suffering from articular cartilage damage of the knee," said Robert C. Spiro, PhD, Sr. Vice President, Aesculap Biologics.
Dr. Scott Hacker is a practicing board certified orthopaedic surgeon in San Diego, California. Serving patients for the past 16 years in private practice, he is a sports medicine expert who specializes in knee and shoulder conditions. His career started in orthopaedic biomechanics and basic science research at the University of California, San Diego where he earned bachelor's and master's degrees in engineering. He was then the director of an orthopaedic research lab for two years before attending the University of California, Irvine School of Medicine. He accepted an orthopaedic residency program in Seattle, Washington and sub-specialized in sports medicine at the Steadman-Hawkins Clinic in Vail, Colorado.
Dr. Hacker returned to his home of San Diego in 2003 and has since established a busy, respected orthopaedic private practice. With a lifelong interest in orthopaedic research, he serves as Principal Investigator for several FDA phase II and III orthopaedic clinical trials.
If you are between 18 and 65 years old, are suffering from pain in only one knee and can provide informed consent, then you may be eligible for this study.
Those interested in participating in the NOVOCART 3D study can learn more by visiting clinicaltrials.gov (NCT01957722). Prospective patients can also obtain additional information by calling the patient assistance line at 844-395-4590.
About Horizon Clinical Research
Horizon Clinical Research is a full service clinical research site that focuses on quality and integrity and is guided by principal investigators highly experienced in clinical research, medicine and surgery. It has an extensive database of patients interested in clinical trials and has over-enrolled nearly every study conducted. Horizon Clinical Research, located in San Diego, California, continues to grow each year. For more information, visit horizontrials.com.
About Aesculap Biologics, LLC
Aesculap Biologics, LLC was established in January 2012 as a subsidiary of Aesculap, Inc. and is focused on biological approaches to the repair and regeneration of diseased or damaged tissues. Using a combination of cells, growth factors and smart biomaterial devices, Aesculap Biologics products can stimulate and support the synthesis of new tissue and enhance the body's own regenerative power to improve the quality of patients' lives. For more information, visit aesculapbiologics.com.
Aesculap, Inc., a B. Braun company, is part of a 180-year-old global organization focused on meeting the needs of an ever-changing healthcare community.
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SOURCE Aesculap Implant Systems, LLC