Aesculap Biologics, LLC Reaches Halfway Mark for Enrollment in Pivotal Phase 3 Clinical Trial of NOVOCART® 3D in Patients with Articular Cartilage Defects of the Knee
CENTER VALLEY, Pa., Feb. 28, 2019 /PRNewswire/ -- Aesculap Biologics, LLC ("Aesculap Biologics") announced today that it has successfully achieved 50 percent enrollment in the ongoing Phase 3 clinical trial of NOVOCART® 3D, an autologous chondrocyte transplantation system designed to treat articular cartilage defects of the knee. To date, approximately 117 of the expected 233 study participants have been treated in the NOVOCART 3D study.
2018 marked the highest enrollment year for the NOVOCART 3D study to date. "We are pleased with the momentum the trial experienced in 2018 and the overall enthusiasm and commitment from the patients and the 30-plus clinical sites currently active in the United States and Canada," said Robert C. Spiro, PhD, Sr. Vice President, Aesculap Biologics. "Reaching the halfway mark for enrollment is an important milestone in bringing this innovative product to market to help patients suffering from articular cartilage defects of the knee."
In 2018, Aesculap Biologics expanded the reach of the NOVOCART 3D clinical study to sites in Canada. Ivan Wong, MD, a principal investigator at one of the participating sites in Canada states, "It's been a wonderful experience, working with this group, to be a part of this multi-center trial. Patients are eager to be a part of it, especially in the Canadian Healthcare system."
The multi-center, prospective, randomized, partially blinded NOVOCART 3D study is designed to evaluate the safety and efficacy of NOVOCART 3D compared to Microfracture (the current standard of care) in the treatment of articular cartilage defects of the knee. NOVOCART 3D was developed in Germany. Since 2003, the product has been used extensively in select European Union countries to treat more than 18,000 patients. The 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 seek regulatory approval for use of the product in the United States.
About NOVOCART 3D
NOVOCART 3D is an investigational biologic-device combination product consisting of an autologous chondrocyte implant derived from the patient's own cartilage cells to regenerate articular cartilage in defects of the knee. The procedure involves an arthroscopic procedure to obtain a cartilage biopsy from a non-weight bearing location in the knee joint. The tissue is sent to the Aesculap Biologics manufacturing facility where the cartilage cells (chondrocytes) are isolated and grown in culture. Approximately three weeks later, the cells are added onto a collagen device and sent to the physician to be implanted into the defect. NOVOCART 3D is not approved for use in the United States or in Canada outside of the study. For more information, visit www.aesculapbiologics.com.
About Aesculap Biologics, LLC
Aesculap Biologics is a regenerative medicine company 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 are intended to stimulate and support the synthesis of new tissue and enhance the body's own regenerative power. For more information, visit www.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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