Biotechnology company Nanochon has received approval from Health Canada for a first-in-human clinical trial of its 3D printed Chondrograft implant designed to treat articular cartilage defects in the knee. The Washington, DC and Baltimore, Maryland-based company is developing orthopedic medical device solutions focused on cartilage treatment using 3D printing technology.
Clinical Trial Design and Patient Population
The Chondrograft system is being evaluated in a prospective, 10-patient, early feasibility study for knee cartilage restoration in eligible patients between 22 and 60 years of age. The study targets patients with femoral condyle and/or trochlea articular cartilage lesions who have failed conservative therapy and meet additional criteria.
The trial will be led by Principal Investigator Dr. Fathi Abuzgaya, an orthopedic surgeon and researcher who has led over 600 clinical trials over the last 25 years. He will collaborate with Sub-Investigators and Sports Medicine Specialists Drs. Joel Lobo, Kajeandra Ravichandiran, and Marcin Kowalczuk at Durham Bone & Joint Specialists (DBJS) in Ontario.
Technology and Clinical Objectives
The minimally-invasive Chondrograft implant is based on research from the Tissue Engineering and Nanotechnology lab at the George Washington University. The device is designed to integrate with a patient's healthy tissue over time and allows for immediate motion and weight-bearing, providing maximum benefit and stability to the patient with reduced recovery time.
The study is designed to assess the safety and performance of Chondrograft, with procedural goals including regrowth of the cartilage-bone matrix, delayed need for arthroplasty, and improvement in patients' knee function and pain.
Clinical Significance and Future Plans
"Thousands of patients with chondral defects, that may evolve to osteoarthritis, live with a reduced quality of life," explained Dr. Lobo. "We are looking forward to the potential for a new treatment option and are excited to begin the Chondrograft study at DBJS. The results of this study could open up a new surgical option, that is minimally invasive to address this unmet clinical need."
Ben Holmes, CEO of Nanochon, stated that "achieving Health Canada approval allows us to gain the clinical data needed to take a giant step forward towards design and execution of a large pivotal North American study."
While the first-in-human trial will take place in Canada, this represents the first step toward a larger clinical program. The company's mission is to develop a new approach to treat cartilage defects so that hundreds of thousands of young, active patients with joint damage can return to their lifestyles without undergoing costly and invasive short-term fixes.
Regulatory Support and Development
Throughout the clinical trial design and regulatory approval process, Nanochon was supported by HN Clinical Consulting in Missouri. Heather Neill, Founder and Principal of HN Clinical Consulting, emphasized the importance of the therapy: "Improving the lives of young adults and athletes by providing a solution to restore knee cartilage and hopefully help patients avoid costly knee replacement is a crucial therapy needed in the orthopedic world."
Dr. Abuzgaya noted that "DBJS is a multidisciplinary musculoskeletal center providing non-operative and operative treatments with accessibility to a variety of sub-specialties. Our study site with dedicated researchers enables greater, more efficient patient recruitment for clinical research and we are privileged to support Nanochon."
