Orthobiologics company Cerapedics has secured an investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to begin a clinical trial of P-15L bone graft.
Under the IDE study, the company will assess the safety and efficacy of P-15L peptide enhanced bone graft compared to autograft in transforaminal lumbar interbody fusion (TLIF) surgery for degenerative disk disease.
Spinal fusion procedures such as TLIF will include joining and stabilizing one or more vertebrae to decrease pain and nerve irritation. A bone graft taken from the patient’s pelvis will be placed in the interbody space to enhance fusion.
An alternative to autologous bone, the new bone graft is based on firm’s synthetic small peptide (P-15) technology and will support bone growth through cell attraction, attachment and activation.
The prospective, single-blinded, multi-center, randomized and non-inferiority pivotal IDE trial will recruit 364 patients with degenerative disk disease at around to 30 clinical trial sites across the US.
The trial will assess the patients prior to surgery and six weeks, three months, 12 months and 24 months post-surgery.
According to the company, the primary endpoint of the trial will be composite clinical success at 24 months based on various factors, including the achievement of radiographic fusion, at least 15-point improvement in the Oswestry Disability Index (ODI), no new or worsening persistent neurological deficit and no subsequent surgical intervention at the index level.
In November 2015, Cerapedics secured premarket approval from the FDA for the use of i-FACTOR bone graft in anterior cervical discectomy and fusion (ACDF) procedures.
Cerapedics CEO Glen Kashuba said: “With regulatory approval to begin a new IDE study of P-15L Bone Graft in TLIF procedures, we are now in position to collect additional Level 1 human clinical data on our next-generation advanced drug-device combination bone graft.
“Several hundred thousand people in the U.S. need surgery for degenerative disk disease every year, and it is our goal to offer surgeons a safe and effective alternative to a patient’s own bone as well as address the evidence gap around commercial bone grafts often used in these procedures.”
Image: The trial will assess the and efficacy of P-15L peptide enhanced bone graft compared to autograft in TLIF surgery for degenerative disk disease. Photo: courtesy of Cerapedics, Inc.