EpiBone IND OK’d for Stem Cell Bone Defect Study

FDA has approved an EpiBone IND to allow a Phase 1/2 clinical trial of its lead bone product, EpiBone-Craniomaxillofacial (EB-CMF), that is being evaluated 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, according to the company. It describes EB-CMF as a living anatomically correct bone graft manufactured from a patient’s own adipose-derived stem cells, which eliminates the need to harvest bone from a patient’s body.

The study will evaluate EB-CMF directly in six patients with mandibular ramus continuity defects which require reconstruction, EpiBone says. It expects the study will inform the exploration of other potential indications for facial reconstructive surgeries requiring bone grafts, as well as studies for cartilage replacement in the knee, and other areas of the body.