Department of Clinical Sciences, Cornell University, Ithaca, New York, USA.
Am J Sports Med. 2021 Jun;49(7):1954-1961. doi: 10.1177/03635465211010466. Epub 2021 Apr 30.
Birth tissue products from amnion, chorion, umbilical cord, amniotic fluid, or cord blood are frequently marketed as viable sources of stem cells and growth factors. It can be difficult for health care professionals to differentiate implied from explicit conclusions in reported product analyses.
To provide an educational platform for health care professionals to interpret data presented in the promotion of birth tissue products.
Descriptive laboratory study and expert opinion; Level of evidence, 5.
A cord blood product was analyzed by 3 methods for cell viability, 2 methods for assessment of cell morphology and cell type, multicolor flow cytometry to identify stem cells, and enzyme-linked immunosorbent assay (ELISA) plus Western blot for analysis of interleukin 1 receptor antagonist protein (IL-1ra). These data were compared with analyses reported by the manufacturer.
Cell viability in the cord blood product was less than reported by the manufacturer, the cells were primarily leukocytes, no stem cells were present, and the concentration of IL-1ra was falsely increased due to nonspecific antibody binding in the sample.
To assess birth tissue products, health care professionals should consider the following: (1) Understanding fluorescent dyes is important for assessing cell viability data-green does not always mean alive. (2) The report of "cells" in the product does not necessarily mean "stem cells"; microscopic images of at least ×20 or a hemogram should be evaluated to determine cell type (leukocyte, red blood cells, etc). (3) There is no single cluster of differentiation (CD) marker on flow cytometry to identify stem cells. (4) Biological tissues are complex substances, and inaccurately increased measurements of growth factors could be present in ELISA results because most ELISAs are not designed or validated for use in biologics. Furthermore, the reported measurement of growth factors should be considered relative to concentrations in native biological tissues and plasma.
Health care professionals should be able to interpret cell viability, cell morphology, stem cell analysis using CD markers, and growth factor analysis when considering use of a birth tissue product in patients.
羊膜、绒毛膜、脐带、羊水或脐带血的组织产品经常被宣传为有活力的干细胞和生长因子的来源。对于医疗保健专业人员来说，区分报告中的产品分析中的隐含结论和明确结论可能具有一定难度。
为医疗保健专业人员提供一个解释出生组织产品推广中呈现的数据的教育平台。
描述性实验室研究和专家意见；证据水平，5。
通过 3 种方法分析脐带血产品的细胞活力，2 种方法评估细胞形态和细胞类型，用多色流式细胞术鉴定干细胞，酶联免疫吸附试验（ELISA）和 Western blot 分析白细胞介素 1 受体拮抗剂蛋白（IL-1ra）。将这些数据与制造商报告的分析结果进行比较。
脐带血产品的细胞活力低于制造商报告的数据，细胞主要是白细胞，不存在干细胞，由于样品中存在非特异性抗体结合，IL-1ra 的浓度被错误地升高。
评估出生组织产品时，医疗保健专业人员应考虑以下几点：（1）了解荧光染料对于评估细胞活力数据非常重要-绿色并不总是表示存活。（2）产品中报告的“细胞”不一定表示“干细胞”；至少应评估×20 倍或血象的显微镜图像，以确定细胞类型（白细胞、红细胞等）。（3）流式细胞术没有单一的分化群（CD）标记物可用于识别干细胞。（4）生物组织是复杂的物质，由于大多数 ELISA 不是为生物制剂设计或验证的，因此 ELISA 结果中可能存在生长因子的不准确增加测量值。此外，报告的生长因子测量值应考虑与天然生物组织和血浆中的浓度相对应。
在考虑将出生组织产品用于患者时，医疗保健专业人员应该能够解释细胞活力、细胞形态、使用 CD 标记物的干细胞分析以及生长因子分析。
