1. Scope
1.1 This guide covers general guidelines for the pre-clinical in vivo assessment of tissue-engineered medical products (TEMPs) intended to repair or regenerate bone in an interbody or posterolateral spinal environment or both. TEMPs included in this guide may be composed of, but are not limited to, natural or synthetic biomaterials or composites thereof and may contain cells or biologically active agents such as growth factors, synthetic peptides, plasmids, or cDNA. The models described in this guide represent a stringent test of a materials ability to induce or augment or both bone growth in the spinal environment. 1.2 While clinically TEMPs may be combined with hardware for initial stabilization or other purposes, the focus of this guide is on the appropriateness of the animal model chosen and evaluation of the TEMP-induced repair and as such does not focus on issues of hardware. 1.3 Guidelines include a description and rationale of various animal models for the in vivo assessment of the TEMP. The animal models use a range of species including rat (murine), rabbit (lapine), dog (canine), goat (caprine), pig (porcine), sheep (ovine), and nonhuman primate (primates). Outcome measures include in vivo assessments based on radiographic, histologic, and CT imaging as well as subsequent in vitro assessments of the repair, including histologic analyses and mechanical testing. All methods are described briefly and referenced. The user should refer to specific test methods for additional detail. 1.4 This guide is not intended to include the testing of raw materials, preparation of biomaterials, sterilization, or packaging of the product. ASTM International standards for these steps are available in Section 2. 1.5 The use of any of the methods included in this guide may not produce a result that is consistent with clinical performance in one or more specific applications. 1.6 Other pre-clinical methods may also be appropriate and this guide is not meant to exclude such methods. The material shall be suitable for its intended purpose. Additional biological testing in this regard would be required. 1.7 The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard. 1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
This standard is needed to provide guidance to researchers needing to assess the potential efficacy of materials or devices in repair or regeneration of bone in the spine to effect a fusion. Users will include academic researchers, industry researchers, government agencies, and IACAUC committees involved in the assessment of materials and devices suitable for repair or regeneration of bone in the spine to effect a fusion.
Keywords
animal models; biomaterials; bone; bone regeneration; bone repair; spine; spinal fusion; pre-clinical; interbody spine fusion; posterolateral spine fusion; products; implants; in vivo; mechanical testing; synthetic biomaterials; TEMPs; tissue-engineered medical products
The title and scope are in draft form and are under development within this ASTM Committee.
Citing ASTM Standards
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