P-15 Putty is a composite bone graft material consisting of a synthetic peptide (P-15) adsorbed onto anorganic bone mineral (ABM). The P-15 fragment is a short chain peptide that mimics a cell binding domain of Type I collagen, that facilitates cell attraction and attachment on the ABM scaffold. P-15 Putty is intended for anterior interbody spinal fusion procedures in patients with degenerative disc disease.
A prospective, randomized, controlled, multi-center trial was designed to investigate the efficacy of P-15 peptide against an autologous bone control group. The hypothesis was that at the P-15 Putty (Test arm) was non-inferior to the “gold standard” autologous bone (Control arm) as determined by fusion rate, NDI scores, and neurological success. A blinded, independent third party was utilized to assess safety, radiologic outcomes, and neurologic outcomes.
Surgeons performed an anterior cervical discectomy. The Control arm received an allograft ring filled with autologous bone. The Test arm received an allograft ring filled with P-15 bone putty. Primary end points were assessed at 12 months. Successful fusion was based upon radiographic examinations and neck disability index (NDI) was scored as the difference between the baseline and the 12-month scores. Neurological status was determined by comparing the preoperative status to changes over the twelve-month period. Overall success was judged by success in all primary endpoints.
A total of 313 patients participated in the study (161 pts.-Test: 152 pts.-Control). Preoperative patient demographics were statistically similar in both populations. The study demonstrated the non-inferiority of P-15 Putty compared to autologous bone for fusion status, change in NDI, and neurological success. Fusion rates were 89% in the P-15 Putty group and 86% in the Control group (p=0.0004 for non-inferiority test). NDI scores improved a mean of 29 points in the P-15 Putty group and 27 points in the Control group (p<0.0001 for non-inferiority test). The neurological success rates was 94% in the P-15 Putty group and 93% in the Control group (p<0.0001 for non-inferiority test). The proportion of subjects with any adverse event at 12 months was almost identical in both groups (p=0.8814). The overall success rate was significantly higher in the P-15 Putty group than the Control group. The proportion of subjects who achieved fusion success, NDI success, neurological success, and safety success was 69% in the P-15 Putty group and 58% in the Control group (p=0.0382).
In summary, the above data support the safety and effectiveness of P-15 Putty for its intended use. The P-15 Putty subjects demonstrated a high rate of fusion, improvement in pain and function, similar adverse event rates to the Control group.
Dr. Jerome Connor received his B.S. degree in Chemistry at Lafayette College and his M.S. and Ph.D. in Biochemistry at The University of Tennessee. His doctoral dissertation involved phospholipid chemistry and the use of pH-sensitive liposomes as drug delivery agents.
Dr. Connor became a post-doctoral fellow at M.D. Anderson Cancer Center at the University of Texas and then joined the facility in the Department of Cell Biology. His research focus was on the influence of lipid organization on reticulocyte generation and red blood cell aging and clearance.
Dr. Connor joined the research and development staff of LifeCell Corporation as Senior Scientist and over a 20-year tenure became the Senior Director of R&D. During his LifeCell tenure Dr. Connor was the technical expert on numerous research projects including: cryopreserved and freeze-dried platelets, freeze-dried red blood cells, adipose stem cell physiology and acellular adipose sponges. He was also the technical leader on multiple projects that translated from the research bench to commercialization including: AlloDerm, Cymetra, Strattice, Revolve and AlloCraft.
Dr Connor is currently the Vice President of R&D at Cerapedics Inc. where he manages the technical staff commercializing the P-15 Putty cervical fusion product. He also leads the research and development of pipeline products in the orthobioloigcal field.