Policy & Regulation
EpiBone Inc gains FDA clearance to begin its first-in-human, Phase 1/2 trial of EB-CMF
23 May 2019 -

Regenerative medicine company EpiBone Inc reported on Wednesday the receipt of the US Food and Drug Administration's (FDA) Investigational New Drug (IND) clearance to launch its Phase 1/2 clinical trial of its lead bone product EpiBone-Craniomaxillofacial (EB-CMF) for the potential treatment of 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, eliminating the need to harvest bone from a patient's body, potentially reducing pain, surgical and hospitalisation time while creating a precision fit with the defect, EpiBone said.

Under the first-in-human, Phase 1/2 clinical study, the company will evaluate the EB-CMF product in six patients with mandibular ramus continuity defects which require reconstruction. The study is designed to demonstrate the effectiveness of EB-CMF in bone reconstruction, integration with the native tissue, as well as its primary safety.

The company expects the Phase 1/2 clinical study to be the basis for 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.