Nanochon, a Washington, DC and Baltimore, MD-based orthopedic device biotech company developing an implant for treating articular cartilage defects in the knee, is thrilled to announce that it was granted Health Canada approval for their first in human clinical trial.
The trial will be led by Principal Investigator, Dr. Fathi Abuzgaya, who will collaborate with Sports Medicine Specialists, Drs. Joel Lobo, Kajeandra Ravichandiran and Marcin Kowalczuk as Sub-Investigators, at the Durham Bone & Joint Specialists (DBJS), located in Ontario, Canada. Dr. Fathi Abuzgaya, is an orthopedic surgeon by training and an esteemed researcher with a track record over the last 25 years, leading +600 clinical trials in all phases and therapeutic areas.
“Our team is delighted that we are the first center to start enrolling participants for the Chondrograft™ study, which represents a novel, minimally invasive treatment for patients with loss of or damaged knee cartilage,” Dr. Abuzgaya commented. “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.”
The Nanochon Chondrograft™ System is being evaluated in a prospective, 10 patient, early feasibility study for use in knee cartilage restoration in eligible patients between 22 and 60 years of age having femoral condyle and /or trochlea articular cartilage lesions who have failed conservative therapy, in addition to meeting other criteria. The study is designed to assess the safety and performance of Chondrograft™, and procedural goals include regrowth of the cartilage-bone matrix, improvement in knee function and pain, and delayed need for arthroplasty.
“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” said Ben Holmes, CEO of Nanochon. “We have the utmost confidence in Dr. Abuzgaya and his clinical team at DBJS to help us recruit the right patients and execute the trial protocol that we have so carefully designed.”
While the first in human trial will take place in Canada, this represents just the first step towards a larger clinical program.
“Thousands of patients with chondral defects, that may evolve to osteoarthritis, live with a reduced quality of life. We are looking forward to the potential for a new treatment option and are excited to begin the Chondrograft™ study at DBJS”, states Dr. Joel Lobo. “The results of this study could open up a new surgical option, that is minimally invasive to address this unmet clinical need.”
Throughout the clinical trial design and regulatory approval process, Nanochon was supported by HN Clinical Consulting (Missouri).
“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,” said Heather Neill, Founder and Principal. “We appreciate Health Canada’s thought-provoking questions throughout their review that helped us put forward the strongest application possible, which ultimately led to our approval.”
HN Clinical Consulting will continue to support the full life cycle of Chondrograft™.
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