EpiBone Gains FDA Approval for Human Trials of Lab-Grown Knee Cartilage

Tuesday, July 25, 2023

EpiBone has received clearance from the FDA to conduct human trials of its lab-grown knee cartilage, following the approval of Investigational New Drug (IND). The treatment, known as an engineered allogenic osteochondral graft, has displayed promising results in pre-clinical studies and could offer potential benefits for individuals with knee cartilage damage resulting from sports injuries, trauma, or post-traumatic arthritis.

The upcoming clinical trials will focus on evaluating the safety and efficacy of EpiBone's graft in comparison to existing treatment methods. Patient recruitment for the trials is expected to commence in early 2024.

Nina Tandon, Co-Founder and CEO of EpiBone, expressed the importance of this development, stating that sports injuries are becoming more common, particularly among young people who require long-term knee functionality. Yet, they often face limited treatment options that do not fully address their symptoms. With EpiBone's lab-grown living cartilage, they aim to harness the potential of living cells to aid cartilage healing, which is usually slow and challenging.

EpiBone's graft presents an alternative to osteochondral allografts, which involve using donor cartilage plugs from cadavers. These allografts are limited in supply, with only around 2,500 available annually, insufficient to meet the rising demand from patients with knee injuries.

To address the supply constraint, EpiBone has developed a laboratory cultivation process. This method involves placing bone marrow stem cells on a scaffold, maturing them into cartilage cells using a proprietary technique, and then utilizing the living cartilage to treat defects of various sizes. Once implanted, the new graft has the potential to mature and integrate with surrounding tissues.

The treatment's effectiveness was initially demonstrated in an equine study conducted by Cornell University's College of Veterinary Medicine, which showcased better integration with surrounding cartilage compared to traditional donor tissue. These findings were presented at the Focus Meeting of the International Cartilage Regeneration & Joint Preservation Society in April.

This milestone marks EpiBone's second product to enter clinical trials. The company is already nearing the conclusion of its first clinical trial, which involves utilizing a patient's own stem cells to grow living, anatomically precise bone grafts.


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