Rich Ivan N
HemoGenix, Inc., Colorado Springs, Colorado, USA
Stem Cells Transl Med. 2015 Sep;4(9):967-73. doi: 10.5966/sctm.2015-0036. Epub 2015 Jul 9.
This article critically reviews current methods to test and characterize umbilical cord blood (UCB) for hematopoietic stem cell transplantation. These tests include total nucleated cell (TNC) count, viability, viable CD34-positive content, and the colony-forming unit assay. It is assumed that the data obtained are sufficient to perform a UCB stem cell transplant without actually determining the quality and potency of the stem cells responsible for engraftment. This assumption has led not only to a high graft failure rate attributed to low or lack of potency, but also to noncompliance with present statutes that require UCB stem cells to be of high quality and, indeed, potency for a transplant to be successful. New evidence now calls into question the quality of the data, based on the UCB processed TNC fraction because using this impure fraction masks and significantly underestimates the functionality of the stem cells in both the segment and the unit. It is proposed that UCB units should be processed to the mononuclear cell fraction and that new cost-effective technology that measures the quality and potency of UCB stem cells be implemented to achieve better practices in UCB testing. These changes would provide the transplant physician with the assurance that the stem cells will perform as intended and would reduce risk and increase safety and efficacy for the patient.
Current stem cell transplantation of umbilical cord blood cells requires testing that includes four basic parameters that do not determine whether the stem cells are of high quality, as required by the Stem Cell Therapeutic and Research Act of 2005. No cord blood units collected or transplanted so far have been tested for stem cell quality or potency. New scientific evidence calls into question cord blood processing and testing practices required by regulatory agencies and standards organizations. A new perspective is described that includes stem cell quality and potency testing that could reduce graft failure rates.
本文批判性地回顾了目前用于检测和表征用于造血干细胞移植的脐带血（UCB）的方法。这些检测包括总核细胞（TNC）计数、活力、活的CD34阳性细胞含量以及集落形成单位测定。人们假定所获得的数据足以进行脐带血干细胞移植，而无需实际确定负责植入的干细胞的质量和效力。这一假定不仅导致了因效力低或缺乏效力而导致的高移植失败率，还导致了不符合现行法规的情况，现行法规要求脐带血干细胞具有高质量，实际上，具有效力移植才能成功。现在新的证据对基于脐带血处理后的TNC组分的数据质量提出了质疑，因为使用这种不纯的组分掩盖并显著低估了干细胞在组分和单位中的功能。建议将脐带血单位处理至单核细胞组分，并实施测量脐带血干细胞质量和效力的新的具有成本效益的技术，以在脐带血检测中实现更好的实践。这些改变将为移植医生提供保证，即干细胞将按预期发挥作用，并将降低风险，提高患者的安全性和疗效。
目前脐带血细胞的干细胞移植需要进行检测，其中包括四个基本参数，但这些参数并不能确定干细胞是否如2005年《干细胞治疗与研究法案》所要求的那样具有高质量。到目前为止，所收集或移植的脐带血单位均未进行干细胞质量或效力检测。新的科学证据对监管机构和标准组织要求的脐带血处理和检测实践提出了质疑。描述了一种新的观点，包括干细胞质量和效力检测，这可能会降低移植失败率。
