Evaluation of rhBMP-2 With an OPLA Carrier in a Canine Posterolateral (Transverse Process) Spinal Fusion Model

Sandhu, Harvinder S.; Kanim, Linda E.A.; Kabo, J. Michael; Toth, Jeffrey M.; Zeegan, E N; Liu, D; Seeger, Leanne L.; Dawson, Edgar G.

doi:10.1097/00007632-199512150-00008

Cited by 175 publications

(65 citation statements)

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“…68 The ultimate goal of this research is to obtain FDA approval for Nell-1-based orthobiologic products for spinal fusion (and, more generally, other bone formation and repair applications). The progression of the phylogenetic complexity of our model systems parallels the preclinical trial history of BMP-2 from dog 77 …”

Section: Discussionmentioning

confidence: 98%

Nell-1 Protein Promotes Bone Formation in a Sheep Spinal Fusion Model

Siu

et al. 2011

Tissue Engineering Part A

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Bone morphogenetic proteins (BMPs) are widely used as bone graft substitutes in spinal fusion, but are associated with numerous adverse effects. The growth factor Nel-like molecule-1 (Nell-1) is mechanistically distinct from BMPs and can minimize complications associated with BMP therapies. This study evaluates the efficacy of Nell-1 combined with demineralized bone matrix (DBM) as a novel bone graft material for interbody spine fusion using sheep, a phylogenetically advanced animal with biomechanical similarities to human spine. Nell-1 + sheep DBM or Nell-1 + heat-inactivated DBM (inDBM) (to determine the osteogenic effect of residual growth factors in DBM) were implanted in surgical sites as follows: (1) DBM only (control) (n = 8); (2) DBM + 0.3 mg/mL Nell-1 (n = 8); (3) DBM + 0.6 mg/mL Nell-1 (n = 8); (4) inDBM only (control) (n = 4); (5) inDBM + 0.3 mg/mL Nell-1 (n = 4); (6) inDBM + 0.6 mg/mL Nell-1 (n = 4). Fusion was assessed by computed tomography, microcomputed tomography, and histology. One hundred percent fusion was achieved by 3 months in the DBM + 0.6 mg/mL Nell-1 group and by 4 months in the inDBM + 0.6 mg/mL Nell-1 group; bone volume and mineral density were increased by 58% and 47%, respectively. These fusion rates are comparable to published reports on BMP-2 or autograft bone efficacy in sheep. Nell-1 is an independently potent osteogenic molecule that is efficacious and easily applied when combined with DBM.

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Section: Discussionmentioning

confidence: 98%

Nell-1 Protein Promotes Bone Formation in a Sheep Spinal Fusion Model

Siu

et al. 2011

Tissue Engineering Part A

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“…BMP have been tested with a variety of biodegradable polymers including PLA , PGA, and PLAGA, and other polymers such as polyethylene glycol, poly--caprolactone, and polyphosphazetes [40][41][42][43][44][45][46]. However, none has proven equal to collagen [47,48].…”

Section: Synthetic Polymers For Bmp Delivery Systemmentioning

confidence: 99%

Synthetic biodegradable polymers as drug delivery systems for bone morphogenetic proteins

Saito

Murakami

Takahashi

et al. 2005

Advanced Drug Delivery Reviews

111

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Bone morphogenetic proteins (BMP) induce bone formation in vivo, and clinical application in repair of bone fractures and defects is expected.However, appropriate systems to deliver BMP for clinical use need to be developed. We synthesized a new synthetic biodegradable polymer, poly-D,L-lactic acid-para-dioxanon-polyethylene glycol block copolymer (PLA-DX-PEG), to serve as a biocompatible, biodegradable polymer for recombinant human (rh) BMP-2 delivery systems. In animal experiments new bone was efficiently formed and a large bone defect was repaired using PLA-DX-PEG/rhBMP-2 composites. In addition, this new polymer could be used as an injectable delivery system for rhBMP-2. The rhBMP-2/PLA-DX-PEG composites also could be combined with other materials such as hydroxyapatite or titanium. This new synthetic polymer might be used for rhBMP-2 delivery in various clinical situations involving repair of bone, leading to great changes in orthopedic treatment.2

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“…Sandhu and associates performed a study using BMP-2 in a canine posterolateral transverse process spine model [38]. They too found that the dosage of BMP was the critical element, and further demonstrated that decortication of host bone was not needed.…”

Section: Recombinant Bmpsmentioning

confidence: 99%