在活体大鼠脊柱融合模型中评估骨生物制品的临床前标准操作程序。

Journal of orthopaedics and sports medicine Pub Date : 2022-01-01 Epub Date: 2022-09-05 DOI:10.26502/josm.511500060
Andrew L Alejo, Scott McDermott, Yusuf Khalil, Hope C Ball, Gabrielle T Robinson, Ernesto Solorzano, Amanda M Alejo, Jacob Douglas, Trinity K Samson, Jesse W Young, Fayez F Safadi
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引用次数: 0

摘要

大鼠动物模型是用于脊柱临床前研究的一种经济、可靠的模型。基于这些临床前动物模型的各种人体外科手术经常出现并发症。因此,需要建立安全有效的临床前动物模型,以确保临床试验的连续性。标准操作程序(SOP)是一种经过验证的方法,可以让研究人员安全、仔细地复制以前成功的手术技术。因此,本研究旨在详细描述一种常见的大鼠双侧后外侧横向脊柱融合术 SOP 所涉及的程序,该 SOP 用于使用浸透胶原的海绵作为矫形生物载体,测试不同矫形生物制剂的有效性和安全性。目前只有两种正生物制剂获得美国食品及药物管理局(FDA)批准用于脊柱融合手术,包括重组骨形态发生蛋白 2(rhBMP-2)和 I-FACTOR。虽然目前还有许多其他的骨生物制剂正在接受测试,但证明其安全性并获得 FDA 批准的一种方法是使用成熟的临床前动物模型。我们概述了术前、术中和术后的手术设置,包括具体的麻醉和安乐死方案。此外,我们还介绍了用于验证脊柱融合术 SOP 的不同术后方法,包括 μCT 分析、组织病理学、生物力学测试和血液分析。该SOP有助于提高未来大鼠脊柱融合手术的有效性、透明度、有效性和可重复性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

A Pre-clinical Standard Operating Procedure for Evaluating Orthobiologics in an <i>In Vivo</i> Rat Spinal Fusion Model.

A Pre-clinical Standard Operating Procedure for Evaluating Orthobiologics in an <i>In Vivo</i> Rat Spinal Fusion Model.

A Pre-clinical Standard Operating Procedure for Evaluating Orthobiologics in an In Vivo Rat Spinal Fusion Model.

The rat animal model is a cost effective and reliable model used in spinal pre-clinical research. Complications from various surgical procedures in humans often arise that were based on these pre-clinical animal models. Therefore safe and efficacious pre-clinical animal models are needed to establish continuity into clinical trials. A Standard Operating Procedure (SOP) is a validated method that allows researchers to safely and carefully replicate previously successful surgical techniques. Thus, the aim of this study is to describe in detail the procedures involved in a common rat bilateral posterolateral intertransverse spinal fusion SOP used to test the efficacy and safety different orthobiologics using a collagen-soaked sponge as an orthobiologic carrier. Only two orthobiologics are currently FDA approved for spinal fusion surgery which include recombinant bone morphogenetic protein 2 (rhBMP-2), and I-FACTOR. While there are many additional orthobiologics currently being tested, one way to show their safety profile and gain FDA approval, is to use well established pre-clinical animal models. A preoperative, intraoperative, and postoperative surgical setup including specific anesthesia and euthanasia protocols are outlined. Furthermore, we describe different postoperative methods used to validate the spinal fusion SOP, which include μCT analysis, histopathology, biomechanical testing, and blood analysis. This SOP can help increase validity, transparency, efficacy, and reproducibly in future rat spinal fusion surgery procedures.

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