1 National & Regional United Engineering Laboratory of Tissue Engineering, Department of Orthopedics, Southwest Hospital, the Third Military Medical University, Chongqing, China.
2 Center of Regenerative and Reconstructive Engineering Technology in Chongqing City, Chongqing, China.
Tissue Eng Part C Methods. 2019 Mar;25(3):137-147. doi: 10.1089/ten.TEC.2018.0323.
Patient-specific individual tissue-engineered bones (iTEBs) have been recognized as a promising strategy for treating large bone defects. However, current construction protocols of iTEBs vary between lots and lack standardization and quality control, hampering further research and application. This study was aimed to detail a standardized constructing protocol for iTEBs, which can be used for both clinical and experimental purposes. The procedure was designed and described as follows: scaffold preparation, cell isolation and culture, and fabrication of iTEBs. Manipulation and caution points in each section were detailed. A series of scales on the quality control and safety monitoring was developed. The effectiveness and safety of iTEBs were evaluated. Eventually, the preparing portion, from cell culture to scaffold treatment, usually required 21 days. Generally, the fabrication section took 5 days. The main advantage of this protocol was that each step was standardized and quality controlling and safety monitoring were performed throughout the process to ensure the homogeneity, reliability, and safety. The resulting iTEBs were effective and applicable to both clinical and experimental purposes. Thus, we have established a refined and standardized protocol detailing the construction process of patient-specific iTEBs that comply with strict quality control and safety criteria. This protocol is relatively easy for graduate students or staff working in the field of bone tissue engineering to implement.
个体化组织工程骨（iTEB）已被认为是治疗大骨缺损的一种有前途的策略。然而，目前 iTEB 的构建方案在批次之间存在差异，缺乏标准化和质量控制，这阻碍了进一步的研究和应用。本研究旨在详细介绍一种标准化的 iTEB 构建方案，该方案可同时用于临床和实验目的。该方案设计和描述如下：支架准备、细胞分离和培养以及 iTEB 的制造。详细说明了每个部分的操作和注意点。开发了一系列质量控制和安全监测的尺度。评估了 iTEB 的有效性和安全性。最终，从细胞培养到支架处理的准备部分通常需要 21 天。一般来说，制造部分需要 5 天。该方案的主要优点是每个步骤都标准化，并在整个过程中进行质量控制和安全监测，以确保均一性、可靠性和安全性。得到的 iTEB 既有效又适用于临床和实验目的。因此，我们建立了一种精细且标准化的方案，详细描述了符合严格质量控制和安全标准的个体化 iTEB 的构建过程。该方案对于从事骨组织工程领域的研究生或工作人员来说相对容易实施。
