Prospective clinical and radiographic evaluation of an allogeneic bone matrix containing stem cells (Trinity Evolution® Viable Cellular Bone Matrix) in patients undergoing two-level anterior cervical discectomy and fusion

Abstract

BackgroundTrinity Evolution® (TE), a viable cellular bone allograft, previously demonstrated high fusion rates and no safety-related concerns after single-level anterior cervical discectomy and fusion (ACDF) procedures. This prospective multicenter clinical study was performed to assess the radiographic and clinical outcomes of TE in subjects undergoing two-level ACDF procedures.MethodsIn a prospective, multicenter study, 40 subjects that presented with symptomatic cervical degeneration at two adjacent vertebral levels underwent instrumented ACDF using TE autograft substitute in a polyetherethereketone (PEEK) cage. At 12 months, radiographic fusion status was evaluated by dynamic motion plain radiographs and thin cut CT with multiplanar reconstruction by a panel that was blinded to clinical outcome. Fusion success was defined by angular motion (≤4°) and the presence of bridging bone across the adjacent vertebral endplates. Clinical pain and function assessments included the Neck Disability Index (NDI), neck and arm pain as evaluated by visual analog scales (VAS), and SF-36 at both 6 and 12 months.ResultsAt both 6 and 12 months, all clinical outcome scores (SF-36, NDI, and VAS pain) improved significantly (p < 0.05) compared to baseline values. There were no adverse events or infections that were attributed to the graft material, no subjects that required revisions, and no significant decreases to mean neurological evaluations at any time as compared to baseline. At 12 months, the per subject and per level fusion rate was 89.4 and 93.4%, respectively. Subgroup analysis of subjects with risk factors for pseudoarthrosis (current or former smokers, diabetic, or obese/extremely obese) compared to those without risk factors demonstrated no significant differences in fusion rates.ConclusionsPatients undergoing two-level ACDF with TE in combination with a PEEK interbody spacer and supplemental anterior fixation had a high rate of fusion success without any serious adverse events related to the graft material.Trial registrationTrinity Evolution in Anterior Cervical Disectomy and Fusion (ACDF) NCT00951938

Differential Effector Response of Amnion‐ and Adipose‐Derived Mesenchymal Stem Cells to Inflammation; Implications for Intradiscal Therapy

“…Moreover, we chose to evaluate bone and cartilage formation as these phenotypes are relevant in the context of the degenerate IVD. For example, the ectopic bone formation has been observed following leakage of intradiscally injected MSCs from degenerate IVDs, and products containing MSCs have been investigated to improve IVD fusions . Additionally, although the relative quantities are different, the primary ECM components that comprise the NP region of the IVD are similar to that of articular cartilage .…”

“…For example, the ectopic bone formation has been observed following leakage of intradiscally injected MSCs from degenerate IVDs, 54 and products containing MSCs have been investigated to improve IVD fusions. 55,56 Additionally, although the relative quantities are different, the primary ECM components that comprise the NP region of the IVD are similar to that of articular cartilage. 57 Another limitation to the study was that the differential response of the MSC types to the same inflammatory conditions could have been due to differences in MSC age and donor variability which was not controlled for in this study.…”

Differential Effector Response of Amnion- and Adipose-Derived Mesenchymal Stem Cells to Inflammation; Implications for Intradiscal Therapy

“…For example, the ectopic bone formation has been observed following leakage of intradiscally injected MSCs from degenerate IVDs,[43] and products containing MSCs have been investigated to improve IVD fusions. [44,45] Additionally, although the relative quantities are different, the primary ECM components that comprise the nucleus pulposus region of the IVD are similar to that of articular cartilage. [46] Another limitation to the study was that the differential response of the MSC types to the same inflammatory conditions could have been due to differences in MSC age and donor variability which was not controlled for in this study.…”

Allogenic Stem Cells in Spinal Fusion: A Systematic Review

“…Five studies of cervical fusion in patients with degenerative disease met the inclusion criteria, including 1 retrospective cohort comparing Osteocel with allograft and 3 case series. The case series include 1 case series using Osteocel Plus, 51 2 case series using Trinity Evolution with local autograft, 52,53 and 1 using Vivigen allograft. 54 Anterior cervical discectomy and fusion (ACDF) was performed in 3 of the 4 series; a variety of procedures was used in the fourth case series.…”

“…However, the authors did not provide data for verification (Table 5). In addition, SF-12/36 physical component summary (PCS) scores improved relative to baseline at 6 and 12 months in one series using Trinity Evolution 52 and at 24 months in one series of Osteocel Plus. 47 (Appendix E).…”