Osteocel-XC (mesenchymal stem cells) / Osiris - LARVOL DELTA

A Review of Commercially Available Cellular-based Allografts. (PubMed, Clin Spine Surg) - "This data indicates that the substantially increased cost of these cellular allografts may not be justified."

Journal • Review

Existing clinical evidence on the use of cellular bone matrix grafts in spinal fusion: updated systematic review of the literature. (PubMed, Neurosurg Focus) - "CBMs are a promising technology with the potential of improving outcome after spinal fusion. However, while the number of studies conducted in humans has tripled since 2014, there is still insufficient evidence in the literature to recommend for or against CBMs relative to cheaper alternative materials. Comparative, multicenter trials and outcome registries free from industry COIs are indicated."

Clinical • Journal • Review • Osteoarthritis

Pseudarthrosis rate following anterior cervical discectomy with fusion using an allograft cellular bone matrix: a multi-institutional analysis. (PubMed, Neurosurg Focus) - "In patients who underwent single-level ACDF, rates of pseudarthrosis associated with the use of the osteobiologic agent Osteocel are higher than the literature-reported rates associated with the use of alternative osteobiologics. This is especially true when Osteocel is combined with a PEEK implant."

Clinical • Journal • Diabetes • Metabolic Disorders • Nephrology • Orthopedics • Osteoarthritis • Osteoporosis • Rheumatology • Tobacco Addiction

Assessment of the Quality and Quantity of Bone Regeneration (clinicaltrials.gov) - P=N/A; N=11; Completed; Sponsor: Ahmad Kutkut; Active, not recruiting ➔ Completed

Clinical • Trial completion

Comparing cellular bone matrices for posterolateral spinal fusion in a rat model. (PubMed, JOR Spine) - "We aim to compare the ability of six commercially-available human CBMs (Trinity ELITE®, ViviGen®, Cellentra®, Osteocel® Pro, Bio4® and Map3®) to form a stable spinal fusion using an athymic rat model of posterolateral fusion...Trinity ELITE and Cellentra were significantly better than other implants at forming new bone and achieving spinal fusion in this rat model at week 6. These results suggest that there may be large differences in the ability of different CBMs to elicit a successful fusion in the posterolateral spine."

Journal • Preclinical

Efficacy of stem cell allograft in maxillary sinus bone regeneration: a randomized controlled clinical and blinded histomorphometric study. (PubMed, Int J Implant Dent) - "Different allograft bone materials can be used in the maxillary sinus augmentation procedures. Stem cell allograft has more osteogenic potential with a better outcome in the wide posterior sinus."

Clinical • Journal

A Comparative Evaluation of Commercially Available Cell-Based Allografts in a Rat Spinal Fusion Model. (PubMed, Int J Spine Surg) - "The Trinity Evolution and Trinity ELITE cellular bone allografts were more effective at creating posterolateral fusion than either the Osteocel Plus allografts or syngeneic bone in this animal model. The superior fusion rate of Trinity cellular bone allografts may lead to better clinical outcome of spinal fusion surgeries."

Journal • Preclinical

Comparative Efficacy of Commonly Available Human Bone Graft Substitutes as Tested for Posterolateral Fusion in an Athymic Rat Model. (PubMed, Int J Spine Surg) - "Grafting material products implanted were demineralized bone matrix (DBM)-based allografts (Accell EVO3, DBX Mix, DBX Strip, Grafton Crunch, Grafton Flex, Grafton Matrix, Grafton Putty, Magnifuse, and Progenix Plus), allografts (OsteoSponge, MinerOss), cellular allograft (Osteocel Plus), ceramics (Mozaik Strip), or activated ceramics (Actifuse ABX Putty, Vitoss BA)...Whole allograft and ceramics may provide osteoconductive scaffolding for mixed-material grafting; however, surgeons should be cautious in using them alone. Direct clinical data are needed to establish efficacy for any bone graft substitute."

Journal • Preclinical

"Assessment of the Quality and Quantity of Bone Regeneration." (clinicaltrials.gov) - P=N/A; N=11; Active, not recruiting; Sponsor: University of Kentucky; Trial completion date: May 2019 ➔ Jul 2020

Clinical • Trial completion date

Allogenic Stem Cells in Spinal Fusion: A Systematic Review. (PubMed, Global Spine J) - "...In a retrospective cohort study fusion rates were not statistically different for Osteocel compared with Vertigraft allograft (88% vs 95%). Fusion rates varied across time frames and intervention products in case series. The overall quality (strength) of evidence of effectiveness and safety of allogenic stem cells products for lumbar and cervical arthrodesis was very low, meaning that we have very little confidence that the effects seen are reflective of the true effects."

Journal • Review