Gulf Breeze, Florida.
Arthroscopy. 2021 Sep;37(9):2883-2884. doi: 10.1016/j.arthro.2021.05.068.
Point-of-care harvest and application of residence stem cells are practical and cost-effective. Tissue formerly considered waste contains these biologically potent cells, and use of such tissue may represent a big part of biologics going forward. The practical application of orthobiologics has slowed because of 3 hurdles: the regulatory requirements of stem cell technologies; the energy, time, and money required to develop a clinical evidence base; and the expense that they present to patients and institutions. Orthobiologic technologies that are simple and cheap and that leverage tissues that are already readily available at the point of care (i.e., the surgical procedure) solve many of these challenges. Cell sources could include knee synovium, shoulder subacromial bursa, bone marrow aspirate, and anterior cruciate ligament injury effusion fluid and stump tissue. A current concern is that collagenase processing and culture expansion are steps resulting in regulatory hurdles in the United States.
即时采集和应用驻留干细胞具有实际意义且经济高效。曾被视为废物的组织中含有这些具有强大生物学功能的细胞,而此类组织的应用可能将成为未来生物制剂的重要组成部分。由于以下 3 个障碍,骨科生物制剂的实际应用进展缓慢:干细胞技术的监管要求;为建立临床证据基础而需要的精力、时间和资金;以及患者和医疗机构面临的费用问题。简单且廉价的骨科生物制剂技术能够利用已经在即时护理点(即手术过程)中易于获得的组织来解决许多这些挑战。细胞来源可以包括膝关节滑膜、肩三角肌下滑囊、骨髓抽吸物,以及前交叉韧带损伤渗出液和残端组织。目前令人关注的是,胶原酶处理和培养扩增是在美国导致监管障碍的步骤。