FDA OKs EpiBone to Begin First-In-Human, Phase 1/2 Trial of Stem Cell-Derived Bone Graft

EpiBone Inc. announced that the U.S. Food and Drug Administration (FDA) has granted its Investigational New Drug (IND) clearance to proceed with a Phase 1/2 clinical trial of its lead bone product EpiBone-Craniomaxillofacial (EB-CMF), as a potential treatment for ramus continuity defects in the mandible. The ramus is a key component of the jaw bone which attaches to the muscles associated with chewing.
 
EB-CMF is a living anatomically correct bone graft manufactured from a patient’s own adipose derived stem cells. This eliminates the need to harvest bone from a patient’s body, potentially reducing pain, surgical and hospitalization time while creating a precision fit with the defect.
 
“We are proud of the work that has been put into this IND, and are grateful to our entire team, as well as all our investors, consultants, and champions in the field who have made this possible,” commented Dr. Nina Tandon, CEO and Co-Founder of EpiBone. “Our technology has the potential to change the field of skeletal reconstruction as we know it. Our goal is to help as many patients as we can to regain optimal form and function, in the most seamless, long-term, and natural way possible.”
 
The Phase 1/2 clinical study will evaluate the EB-CMF product directly in patients with mandibular ramus continuity defects which require reconstruction. In addition to the primary safety of EB-CMF, the study is also designed to demonstrate the effectiveness of EB-CMF in bone reconstruction in addition to integration with the native tissue. The company expects to enroll 6 patients in this study. The company hopes this study will inform the exploration of other potential indications for other facial reconstructive surgeries requiring bone grafts, as well as studies for cartilage replacement in the knee, and other areas of the body.