The first patients have been enrolled in an investigational device exemption (IDE) clinical trial evaluating the safety and efficacy of the next-generation P-15L peptide enhanced bone graft (Cerapedics) in transforaminal lumbar interbody fusion (TLIF) surgery. Cerapedics gained FDA approval earlier this year to commence this trial.
The prospective, single-blinded, multi-centre, randomised, non-inferiority pivotal IDE study will evaluate the safety and efficacy of P-15L bone graft compared to use of an autologous bone graft when applied in TLIF surgery. The study will include a total of 364 patients with degenerative disc disease at up to 30 clinical trial sites across the USA once it is fully enrolled.
“We are pleased to announce enrollment of the first patients in our IDE study in TLIF procedures,” says Glen Kashuba, chief executive officer of Cerapedics. “More than 300,000 people in the USA suffer from degenerative disc disease that leads to pain and nerve irritation and often requires surgery. Our first-generation bone graft is already approved for anterior cervical discectomy and fusion (ACDF) procedures, and this pivotal study in TLIF procedures will be instrumental in a second premarket approval (PMA) application for our next-generation P-15 technology in the years ahead.”
In TLIF procedures, surgeons historically obtained bone graft from the patient’s pelvis and placed it in the interbody space to promote fusion when joining and stabilising one or more vertebrae. P-15L Bone Graft is based on a biomimetic small peptide (P-15) technology developed by Cerapedics to support bone growth through cell attraction, attachment, and activation, and is designed to be used as a substitute for autologous bone. In 2015, the company’s first-generation bone graft became the first bone graft to be approved for use in the cervical spine and the second PMA-approved bone graft in the spine.
According to a company statement, Cerapedics’ i-FACTOR peptide enhanced bone graft is the only biologic bone graft in orthopaedics that incorporates a small peptide as an attachment factor to stimulate the natural bone healing process.
“This important first patient enrolled signifies the culmination of substantial efforts on the part of many external and internal collaborators,” comments Jeffrey G Marx, president and chief operating officer of Cerapedics. “We are grateful for all of the efforts that have gotten us to this point and are excited about the future of this study and the P-15L Bone Graft technology. We would like to give special thanks to Dr Small and his clinical research team for enrolling the first patient.”
“The team at the Foundation for Orthopaedic Research and Education is pleased to participate in this important IDE trial of P-15L Bone Graft. Being involved in the study of a new drug-device combination product for spinal fusion is gratifying. We look forward to this first step in potentially expanding the indications for use of peptide enhanced bone grafts to the lumbar spine,” says John M Small, whose clinical research team at the Florida Orthopaedic Institute (Tampa, USA) have enrolled the first patient.