Doi:10.1016/j.spinee.2007.07.020

Proceedings of the NASS 22nd Annual Meeting / The Spine Journal 7 (2007) 1S–163S concentration. There does not appear to be any clinical evidence of a hyper- sensitivity reaction or other adverse response.
FDA DEVICE/DRUG STATUS: rhBMP-2: Approved for this indication.
14. Stem Cells from Human Fat as Cellular Delivery Vehicles ina Rat Posterolateral Spine Fusion ModelWellington Hsu, Jeffrey Wang, MD, Nancy Liu, 13. The Natural History of Subsequent Adjacent Level Vertebral Lucie Krenek, Patricia Zuk, Mark HedricProsper Jay Lieberman, MD; 1University of California, Los Angeles, Bruce Frankel, Alex Vandergrift, 1Medical University of South Los Angeles, CA, USA; 2University of California, Los Angeles, Santa Monica, CA, USA; 3UCLA Medical Center, CA, USA; 4Macropore BACKGROUND CONTEXT: Osteoporotic vertebral compression frac- tures (VCF) are routinely treated with the vertebral augmentation proce- BACKGROUND CONTEXT: Mesenchymal stem cells derived from hu- dures (VAP), vertebroplasty and kyphoplasty. Both are reported to be an man liposuction aspirates, termed processed lipoaspirate cells (PLAs), effective means of pain relief; however, there may be an increased risk of de- have been utilized in the induction of bone formation as cellular delivery veloping subsequent VCFs after such procedures. The risk of subsequent vehicles for tissue engineering and gene therapy.
VCF after 1 fracture is reported to be 19.2% at one year, and is widely PURPOSE: This study seeks to evaluate the efficacy of BMP-2-producing reported as the benchmark figure to define the expected natural history of adipose-derived stem cells (ADSC) in inducing a posterolateral spine subsequent fractures in patients after VAPs. This number should not be used as the standard to compare to in order to determine whether or not VAPs re- STUDY DESIGN/SETTING: Pre-clinical animal model.
sult in an increased incidence of subsequent VCFs for several reasons.
OUTCOME MEASURES: Plain radiographs fusion scores from manual Firstly, it takes into account all subsequent fractures, not just the most rele- palpation microCT histologic analysis.
vant ‘‘adjacent level’’ fractures likely to result from the increased stiffness of METHODS: A total of five groups of athymic rats were used (n58): augmented veterbrae. Secondly, it does not account for the fact that many Group I: 5Â106 adipose-derived stem cells transduced with Ad-BMP-2 ad- patients undergoing VAPs are on bisphosphonate therapy, agents reported enoviral vector, Group II: 5Â106 ADSCs treated with osteogenic media to reduce subsequent VCFs by 50%. Finally, it is not known whether or and exogenous BMP-2, Group III and IV: 10 ug and ug of rh-BMP2, not bisphosponate therapy reduces the incidence of adjacent-level VCFs.
respectively, and Group V: 5Â106 ADSCs alone.
PURPOSE: The purpose of this study was to determine the natural history RESULTS: All animals in Group I demonstrated successful spinal fusion of subsequent ‘‘adjacent-level’’ VCFs in patients with osteoporosis both with large fusion masses four weeks postoperatively assessed by plain ra- with and without bisphosphonate therapy, and with and without VAPs.
diographs, fusion scores from manual palpation, quantifiable bone forma- STUDY DESIGN/SETTING: A retrospective review of the treatment and tion on microCT, and histologic analysis. In fact, Group I specimens placebo arms from several large risedronate trials was analyzed to deter- consistently revealed spinal fusion at the proximal level where no fusion mine the natural history of subsequent ‘‘adjacent-level’’ VCFs for both bed was prepared surgically. In contrast, Group II (ADSC-treated) animals bisphosphonate-treated and bisphosphonate-naı¨ve patients. These figures demonstrated minimal bone formation even eight weeks after implanta- were compared to those from patients with subsequent ‘‘adjacent-level’’ tion. None of the negative control animals demonstrated successful spine PATIENT SAMPLE: 2000 patients with previous VCFs, enrolled in sev-eral large risedronate trials were studied for the occurrence of subsequent‘‘adjacent-level’’ VCFs, and compared to those in patients undergoingVAPs.
OUTCOME MEASURES: The incidence of subsequent adjacent-levelVCFs was determined as reported from radiographic analysis.
METHODS: Data sets were retrospectively reviewed to determine thesubsequent fracture rate at adjacent levels (one level above or below a pre-vious known fracture). This was performed for both the treatment andplacebo arms of previous risedronate trials. As such, the natural historyof subsequent ‘‘adjacent-level’’ VCFs for both bisphosphonate-treatedand bisphosphonate-naı¨ve patients was calculated and compared to thosefrom patients after undergoing VAPs.
RESULTS: Of the 19% subsequent VCFs occuring in the year followinga single fragility fracture, only approximately 50% appear at an adjacent- CONCLUSIONS: ADSCs show great promise as cellular delivery level regardless of whether or not the patient was on bisphosphonate ther- vehicles for BMP-2 but further modifications of existing cell-based proto- apy. Published series on VAPs indicate that the risk of subsequent fracture cols are necessary before this type of strategy can be adapted for use in after a VAP ranges from 0–16% in vertebroplasty and 7–45% in kypho- plasty patients. If this lower natural history rate is compared to the rate FDA DEVICE/DRUG STATUS: This abstract does not discuss or include of VCFs occurring after VAPs, a concern is raised that these procedures may be causing an increased incidence in adjacent-level fractures.
CONCLUSIONS: The rate of subsequent adjacent-level VCFs occuring after VAPs appears to be greater than the expected natural history ofspontaneously occuring adjacent–level fractures. Efforts to identify andmitigate causative factors are warranted.
FDA DEVICE/DRUG STATUS: Vertebroplasty: Approved for this 15. The Adjunctive Effect of a Binding Peptide on Bone Morphogenic Protein in an Animal Spinal Fusion ModelAhmet Alanay, MDChihui Chen, Sang-Hun Lee, Masashi Miyazaki, MD, Elsa Brochman, Samuel Murray, M, Antonia Napoli,

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