JERSEY CITY, N.J., July 24, 2023 /PRNewswire/ -- EpiBone has received Investigational New Drug (IND) clearance from the FDA to begin testing its lab-grown knee cartilage in humans. The treatment, known as an engineered allogenic osteochondral graft, has shown promise in pre-clinical studies and could benefit people with damaged knee cartilage caused by sports injuries, trauma or post-traumatic arthritis.
Clinical trials will evaluate the safety and efficacy of EpiBone's graft compared to current treatment, with patient recruitment set to begin as soon as early 2024.
"Sports injuries are becoming more common, particularly in young people who need their knees to function for many years to come. Yet they often have limited treatment options that don't fully alleviate their symptoms," said Nina Tandon, Co-Founder and CEO of EpiBone. "With this lab-grown living cartilage, we are able to offer patients a new avenue to harness the power of living cells to help cartilage heal when it normally is notoriously slow to recover from injury, if it recovers at all."
The graft could offer an alternative for osteochondral allografts, which are donor plugs of cartilage taken from cadavers, and while efficacious, are in short supply – only about 2,500 each year – not enough for the growing number of patients whose knees are damaged.
EpiBone seeks to solve this supply constraint by cultivating the grafts in the lab, eliminating risks of disease transmission and donor matching issues. The process involves placing bone marrow stem cells on a scaffold in the lab, maturing them into cartilage cells through a proprietary technique, and then utilizing the living cartilage to treat various-size defects. Once implanted, the new graft has potential to mature and integrate with surrounding tissues.
This innovative treatment was first tested in an equine study conducted by Cornell University's College of Veterinary Medicine, which demonstrated that EpiBone's graft integrated better with surrounding cartilage than the current gold standard of using donor tissue. Those findings were shared in April at the Focus Meeting of the International Cartilage Regeneration & Joint Preservation Society.
This is EpiBone's second product to advance into clinical trials. The company is approaching the end of its first clinical trial, using a patient's own stem cells to grow living anatomically precise bone grafts.
About EpiBone
EpiBone, Inc. is a privately-held regenerative medicine company focused on skeletal reconstruction. Sitting at the intersection of biology and engineering, the company harnesses the power of cells to create living solutions that become a seamless part of a patient's body. EpiBone is currently developing a pipeline of bone, cartilage, and other skeletal tissue products. For more information, visit epibone.com.
Disclaimer
This communication contains forward-looking statements, which can generally be identified by words such as "plans," "change," "will," "following", "strengthening," "developing," the negative of these words and similar words and expressions, which are based on EpiBone's current expectations, assumptions, estimates and projections about its business, technology, product development and industry. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and include, without limitation, EpiBone's ability to (1) adequately protect or enforce its intellectual property rights, (2) develop and commercialize new products and technologies on a timely basis (or at all), (3) risks associated with acquisitions and strategic investments and (4) attract and retain qualified personnel. Accordingly, you are cautioned not to place undue reliance on such forward-looking statements. Additionally, this communication does not constitute an offer to sell or a solicitation of an offer to buy securities.
SOURCE EpiBone, Inc.
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