{"id":4303,"date":"2025-07-27T23:53:00","date_gmt":"2025-07-27T23:53:00","guid":{"rendered":"http:\/\/biogroupvietnam-worldpress.local\/2025\/08\/18\/cfu-assay-evaluation-hematopoietic-stem-cells\/"},"modified":"2025-09-29T14:00:20","modified_gmt":"2025-09-29T07:00:20","slug":"cfu-assay-danh-gia-te-bao-goc-tao-mau","status":"publish","type":"post","link":"https:\/\/biogroupvietnam.com\/en\/blog\/cfu-assay-evaluation-hematopoietic-stem-cells\/","title":{"rendered":"Why is the CFU assay important in testing HSPCs before transplantation?"},"content":{"rendered":"<p><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 12pt;\">The CFU (Colony-Forming Units) assay ensures the quality of hematopoietic stem cells (HSCs) before transplantation. The CFU assay is used as a standard to assess the potency of HSCs by the FDA, FACT, and AABB.<\/span><\/p>\n<figure class=\"image\"><figcaption>\n<div id=\"attachment_6432\" style=\"width: 1432px\" class=\"wp-caption alignnone\"><img fetchpriority=\"high\" decoding=\"async\" aria-describedby=\"caption-attachment-6432\" class=\"wp-image-6432 size-full\" src=\"https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2025\/07\/CFU-Assay-dong-vai-tro-quan-trong-trong-kiem-nghiem-HSCs.jpg\" alt=\"\" width=\"1422\" height=\"800\" srcset=\"https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2025\/07\/CFU-Assay-dong-vai-tro-quan-trong-trong-kiem-nghiem-HSCs.jpg 1422w, https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2025\/07\/CFU-Assay-dong-vai-tro-quan-trong-trong-kiem-nghiem-HSCs-300x169.jpg 300w, https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2025\/07\/CFU-Assay-dong-vai-tro-quan-trong-trong-kiem-nghiem-HSCs-1024x576.jpg 1024w, https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2025\/07\/CFU-Assay-dong-vai-tro-quan-trong-trong-kiem-nghiem-HSCs-768x432.jpg 768w, https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2025\/07\/CFU-Assay-dong-vai-tro-quan-trong-trong-kiem-nghiem-HSCs-600x338.jpg 600w, https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2025\/07\/CFU-Assay-dong-vai-tro-quan-trong-trong-kiem-nghiem-HSCs-90x51.jpg 90w\" sizes=\"(max-width: 1422px) 100vw, 1422px\" \/><p id=\"caption-attachment-6432\" class=\"wp-caption-text\">The CFU Assay plays an important role in testing HSCs (Hematopoietic Stem Cells)<\/p><\/div>\n<\/figcaption><\/figure>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_80 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/biogroupvietnam.com\/en\/blog\/cfu-assay-evaluation-hematopoietic-stem-cells\/#Overview_of_Hematopoietic_Stem_Cells_HSCs_and_the_CFU_assay\" >Overview of Hematopoietic Stem Cells (HSCs) and the CFU assay<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/biogroupvietnam.com\/en\/blog\/cfu-assay-evaluation-hematopoietic-stem-cells\/#What_are_hematopoietic_stem_and_progenitor_cells_HSPCs\" >What are hematopoietic stem and progenitor cells (HSPCs)?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/biogroupvietnam.com\/en\/blog\/cfu-assay-evaluation-hematopoietic-stem-cells\/#Characterization_tests_for_hematopoietic_stem_and_progenitor_cells_HSPCs\" >Characterization tests for hematopoietic stem and progenitor cells (HSPCs)<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/biogroupvietnam.com\/en\/blog\/cfu-assay-evaluation-hematopoietic-stem-cells\/#Phenotypic_assays\" >Phenotypic assays<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/biogroupvietnam.com\/en\/blog\/cfu-assay-evaluation-hematopoietic-stem-cells\/#Functional_assays\" >Functional assays<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/biogroupvietnam.com\/en\/blog\/cfu-assay-evaluation-hematopoietic-stem-cells\/#Why_do_experts_choose_the_CFU_assay\" >Why do experts choose the CFU assay?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/biogroupvietnam.com\/en\/blog\/cfu-assay-evaluation-hematopoietic-stem-cells\/#What_are_the_regulations_for_the_CFU_assay\" >What are the regulations for the CFU assay?<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/biogroupvietnam.com\/en\/blog\/cfu-assay-evaluation-hematopoietic-stem-cells\/#FDA_compliance_guidelines\" >FDA compliance guidelines<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/biogroupvietnam.com\/en\/blog\/cfu-assay-evaluation-hematopoietic-stem-cells\/#FACT-JACIE_standards_8th_Edition\" >FACT-JACIE standards (8th Edition)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/biogroupvietnam.com\/en\/blog\/cfu-assay-evaluation-hematopoietic-stem-cells\/#AABB_standards_11th_Edition\" >AABB standards (11th Edition)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/biogroupvietnam.com\/en\/blog\/cfu-assay-evaluation-hematopoietic-stem-cells\/#NetCord-FACT_banking_standards_8th_Edition_%E2%80%93_DRAFT\" >NetCord-FACT banking standards (8th Edition &#8211; DRAFT)<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/biogroupvietnam.com\/en\/blog\/cfu-assay-evaluation-hematopoietic-stem-cells\/#Standardizing_the_CFU_assay_process_with_STEMCELL_Technologies\" >Standardizing the CFU assay process with STEMCELL Technologies<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/biogroupvietnam.com\/en\/blog\/cfu-assay-evaluation-hematopoietic-stem-cells\/#References\" >References<\/a><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"Overview_of_Hematopoietic_Stem_Cells_HSCs_and_the_CFU_assay\"><\/span><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 20pt;\">Overview of Hematopoietic Stem Cells (HSCs) and the CFU assay<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"background-color: transparent; color: #0e101a; font-family: Arial,sans-serif; font-size: 12pt;\">Stem cells are specialized cells that have the unique ability to self-renew, thereby generating a source of undifferentiated stem cells. They can also differentiate into specific types of cells, with specialized functions and full maturity. Therefore, stem cells are considered the &#8220;building blocks&#8221; of the tissues and organs where they reside.<\/span> <span style=\"background-color: transparent; color: #0e101a; font-family: Arial,sans-serif; font-size: 12pt;\">Among the various types of stem cells, hematopoietic stem cells (HSCs) are the most extensively studied type of mature stem cell. They are considered a promising cell source for applications in both basic science and clinical medicine. Historically, research on HSCs began in the 1940s when a breakthrough experiment showed that intravenous bone marrow (BM) cells could prevent death in irradiated mice by restoring blood cell production. Since then, HSCs have been studied and applied in medical therapies and scientific research for decades..&nbsp;<\/span> <span style=\"background-color: transparent; color: #0e101a; font-family: Arial,sans-serif; font-size: 12pt;\">Over time, more sophisticated tools have been developed to evaluate the behavior of pure hematopoietic cell populations capable of generating blood cells. One of the most reliable tools is the Colony-Forming Unit (CFU) assay. This method helps identify, count, and analyze clusters of cells formed from hematopoietic stem and progenitor cells (HSPCs) that have differentiated into myeloid, erythroid, and lymphoid lineages.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"What_are_hematopoietic_stem_and_progenitor_cells_HSPCs\"><\/span><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 20pt;\">What are hematopoietic stem and progenitor cells (HSPCs)?<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"background-color: transparent; color: #0e101a; font-family: Arial,sans-serif; font-size: 12pt;\">Hematopoietic stem and progenitor cells (HSPCs) comprise a heterogeneous population of stem cells and progenitor cells present in the body. Among these, hematopoietic progenitor cells (HPCs) are cells that have committed to differentiation and can differentiate into multi-potent, bi-potent, or uni-potent blood cells. Every year, the human body produces approximately 1.4 x 10\u00b9\u2074 new blood cells, including around 1.75 x 10\u00b9\u00b9 red blood cells, 7 x 10\u00b9\u2070 granulocytes, and 1.75 x 10\u00b9\u00b9 platelets. The balance of hematopoiesis ensures that the proper ratios of different progenitor cells are produced to meet the body&#8217;s needs when infected or injured.<\/span> <span style=\"background-color: transparent; color: #0e101a; font-family: Arial,sans-serif; font-size: 12pt;\">Hematopoietic stem cells (HSCs) can self-renew and differentiate into different blood cell lineages. From these stem cells, the differentiation process splits into two main lineages: myeloid (myeloid progenitor cells) and lymphoid (lymphoid progenitor cells). The myeloid lineage produces various types of cells, such as eosinophils, basophils, neutrophils, monocytes, platelets, and erythrocytes. Meanwhile, the lymphoid lineage differentiates into crucial immune cells, such as T-cells and B-cells. This highlights the vital role of HSPCs in maintaining balance and development within the body&#8217;s hematopoietic system.<\/span><\/p>\n<figure class=\"image image_resized\" style=\"width: 100%;\"><img decoding=\"async\" style=\"aspect-ratio: 511\/303;\" src=\"https:\/\/lh7-rt.googleusercontent.com\/docsz\/AD_4nXd0fenmrxMpa0iOCrFaFG2z-q88nS2M3MwO9ytlXkztCjoyU3g7YV4CKxPKIfi8CgfEj6vCgfVrguslgb12RXWkLZx0QjmWtYTguAFLbNQcnSS0tEg-TR69ciWlx-tGYBd2YoYs?key=41aW6BA3xE8Hr216Rqut3Q\" alt=\"The differentiation process of hematopoietic stem cells (HSCs)\" width=\"511\" height=\"303\" \/><figcaption><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 12pt;\"><i>The differentiation process of hematopoietic stem cells (HSCs) (Source: Medical News Today)<\/i><\/span><\/figcaption><\/figure>\n<h2><span class=\"ez-toc-section\" id=\"Characterization_tests_for_hematopoietic_stem_and_progenitor_cells_HSPCs\"><\/span><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 20pt;\">Characterization tests for hematopoietic stem and progenitor cells (HSPCs)<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 11pt;\">There are several types of assays for HSPC characterization, and the suitable test depends on the maturity of the cells being investigated. Generally, assays can be categorized as either phenotypic or functional assays.<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Phenotypic_assays\"><\/span><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 16pt;\">Phenotypic assays<\/span><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"background-color: transparent; color: #0e101a; font-family: Arial,sans-serif; font-size: 12pt;\">Phenotypic assays, such as flow cytometry, are used to investigate cell surface markers, like CD34, a phospho-glycoprotein first identified on HSPCs. However, it is also present in other cell types, such as those found in vascular tissue.<\/span><\/p>\n<figure class=\"image\"><img decoding=\"async\" style=\"aspect-ratio: 575\/164;\" src=\"https:\/\/lh7-rt.googleusercontent.com\/docsz\/AD_4nXcQEwsYwiCyoanvyMd0JI7Yxw84rCX_zKvFAvFkWXPpmOwz8Ns0XuzkDtuQe2Ek3Ux2Q0lwcx4a82gGNkWONMyfAg3cb9u7ZN35OwQ5pzQgBRxB9J4HP6zZ_q_kOAhTYdIBqcbJUw?key=41aW6BA3xE8Hr216Rqut3Q\" alt=\"The dot plot from FACS analysis shows the proportion of CD34\u207a\/CD45\u207a cells\" width=\"575\" height=\"164\" \/><figcaption><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 11pt;\"><i>The dot plot from FACS analysis shows the proportion of CD34\u207a\/CD45\u207a cells (Source: STEMCELL Technologies)<\/i><\/span><\/figcaption><\/figure>\n<h3><span class=\"ez-toc-section\" id=\"Functional_assays\"><\/span><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 16pt;\">Functional assays<\/span><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"background-color: transparent; color: #0e101a; font-family: Arial,sans-serif; font-size: 12pt;\">On the other hand, functional assays measure specific biological characteristics that indicate the cell&#8217;s function. These assays can be performed using in vivo or in vitro methods, each with its advantages and disadvantages.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 12pt;\">The most effective method for assessing hematopoietic stem cell (HSC) function is the in vivo mouse engraftment assay, which builds upon the groundbreaking work of Till &amp; McCulloch in the 1960s. However, this type of assay is often time-consuming, expensive, and difficult to evaluate. As a result, the CFU in vitro assay is recommended for assessing HSPC quality before transplantation, as it has been shown to correlate well with in vivo engraftment models.<\/span><\/p>\n<ul>\n<li><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 12pt;\"><strong>In vivo assays:<\/strong> Based on animal transplantation models, this method evaluates multi-lineage cell formation after more than 5 weeks.<\/span><\/li>\n<li><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 12pt;\"><strong>In vitro assays:<\/strong> Ph\u01b0\u01a1ng ph\u00e1p CFU (Colony Forming Unit) \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 s\u1ef1 ph\u00e1t tri\u1ec3n c\u1ee7a t\u1ebf b\u00e0o ti\u1ec1n th\u00e2n (progenitor) v\u00e0 kh\u1ea3 n\u0103ng bi\u1ec7t h\u00f3a c\u1ee7a ch\u00fang.<\/span><\/li>\n<\/ul>\n<p style=\"text-align: justify;\">&nbsp;<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Why_do_experts_choose_the_CFU_assay\"><\/span><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 20pt;\">Why do experts choose the CFU assay?<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<figure class=\"image\"><img loading=\"lazy\" decoding=\"async\" style=\"aspect-ratio: 602\/265;\" src=\"https:\/\/lh7-rt.googleusercontent.com\/docsz\/AD_4nXemPGsYDrLEoP1kCEuzotn79WsjX8JV2YlKgrKC8FnHT-WABfgbM9v7jOY7mzASsc3tsDfzc_M-cPq6zSOi1FzzzNmPOgnEXiil5ODtzIwP0xEIygcOIpRXHp78VC8l5BJgJeG99A?key=41aW6BA3xE8Hr216Rqut3Q\" alt=\"The pyramid model describes the differentiation process of hematopoietic cells\" width=\"602\" height=\"265\" \/><figcaption><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 12pt;\"><i>The pyramid model describes the differentiation process of hematopoietic cells (Source: STEMCELL Technologies)<\/i><\/span><\/figcaption><\/figure>\n<p><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 12pt;\">Firstly, while other functional assays, like in vivo mouse engraftment or long-term culture-initiating cell (LTC-IC) assays, may be more suitable for assessing the function of primitive HSPCs, they are very complex and time-consuming, taking anywhere from 5 weeks to 6 months to complete. In contrast, the CFU assay takes only about 2 weeks, providing a significantly faster evaluation.<\/span> <span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 12pt;\">Moreover, the CFU assay has long been shown to have a strong correlation with successful engraftment in transplant recipients. A study by KM Page (2011) showed that the &#8220;CFU dose&#8221; is most closely related to the engraftment of neutrophils and platelets. This demonstrates that the CFU assay not only evaluates clustering potential but also accurately predicts transplant efficacy in clinical settings.<\/span> <span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 12pt;\">With its short duration and ability to accurately predict cell engraftment success, the CFU assay is the ideal choice for assessing the quality of HSPCs before transplantation. It is considered the gold standard for evaluating the potency of stem cell products because it correlates with successful engraftment rates and overall survival in HSC transplant recipients (Velier et al., 2019).<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"What_are_the_regulations_for_the_CFU_assay\"><\/span><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 20pt;\">What are the regulations for the CFU assay?<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"background-color: transparent; color: #0e101a; font-family: Arial,sans-serif; font-size: 12pt;\">\u0110\u1ed1i v\u1edbi c\u00e1c ng\u00e2n h\u00e0ng m\u00e1u cu\u1ed1ng r\u1ed1n (Cord blood banks) \u1edf M\u1ef9, t\u1ea5t c\u1ea3 \u0111\u1ec1u ph\u1ea3i \u0111\u01b0\u1ee3c \u0111\u0103ng k\u00fd v\u1edbi FDA. H\u1ea7u h\u1ebft c\u00e1c ng\u00e2n h\u00e0ng n\u00e0y \u0111\u1ec1u \u0111\u01b0\u1ee3c ch\u1ee9ng nh\u1eadn b\u1edfi AABB ho\u1eb7c FACT, v\u00e0 c\u1ea3 hai t\u1ed5 ch\u1ee9c n\u00e0y \u0111\u1ec1u y\u00eau c\u1ea7u d\u1eef li\u1ec7u CFU tr\u01b0\u1edbc khi \u0111\u00f4ng l\u1ea1nh (pre-freeze CFU data).<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"FDA_compliance_guidelines\"><\/span><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 16pt;\">FDA compliance guidelines<\/span><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"background-color: transparent; color: #0e101a; font-family: Arial,sans-serif; font-size: 12pt;\">The FDA requires stability testing and specifies CFU assays: &#8220;The stability testing program should include, but is not limited to, potency, integrity, and sterility of the product. Non-clinical laboratory data, such as in vitro CFU assays, may be used as part of the stability testing program, accompanied by clinical engraftment data if available.&#8221; (FDA-2006-D-0157)<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"FACT-JACIE_standards_8th_Edition\"><\/span><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 16pt;\">FACT-JACIE standards (8th Edition)<\/span><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"background-color: transparent; color: #0e101a; font-family: Arial,sans-serif; font-size: 12pt;\">FACT requires an annual evaluation program to assess the survival rates and potency of cryopreserved cell therapy products. (D9.2.3)&nbsp;<\/span> <span style=\"background-color: transparent; color: #0e101a; font-family: Arial,sans-serif; font-size: 12pt;\">The evaluation must represent all processing methods and the maximum sample storage duration. (D9.2.3.1)<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"AABB_standards_11th_Edition\"><\/span><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 16pt;\">AABB standards (11th Edition)<\/span><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"background-color: transparent; color: #0e101a; font-family: Arial,sans-serif; font-size: 12pt;\">The stability evaluation program must include: product container integrity, viable cell recovery, and potency evaluation of related cells. (5.20.2.1). The relevant potency assay must be defined by the performing facility. (5.17C, 5a).<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"NetCord-FACT_banking_standards_8th_Edition_%E2%80%93_DRAFT\"><\/span><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 16pt;\">NetCord-FACT banking standards (8th Edition &#8211; DRAFT)<\/span><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"background-color: transparent; color: #0e101a; font-family: Arial,sans-serif; font-size: 12pt;\">Evidence of potency must be provided through a CFU assay or other validated potency tests on fresh samples obtained immediately after processing. Additionally, on representative samples before release to clinical programs. (D9, appendix V). [1]<\/span> <span style=\"background-color: transparent; color: #0e101a; font-family: Arial,sans-serif; font-size: 12pt;\">This highlights the importance of CFU assays in ensuring the quality and potency of umbilical cord blood products before use for clinical transplantation purposes.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Standardizing_the_CFU_assay_process_with_STEMCELL_Technologies\"><\/span><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 20pt;\">Standardizing the CFU assay process with STEMCELL Technologies<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<figure class=\"image\"><img loading=\"lazy\" decoding=\"async\" style=\"aspect-ratio: 602\/327;\" src=\"https:\/\/lh7-rt.googleusercontent.com\/docsz\/AD_4nXcO4l2Bem006q-M13gXyBxMSJLBm2XQV3ACVK2TRbY2aT0g9eyvPKmRSpK8FfrXo3jL9U7Cbf_BQSc9Xgjn-TGY8sIBYWVyHxhqGU0Dw2GtUn_4KHA_2DP8ONd2_NUHjKw5GDI4FQ?key=41aW6BA3xE8Hr216Rqut3Q\" alt=\"STEMCELL Technologies provides tools to standardize the CFU assay\" width=\"602\" height=\"327\" \/><figcaption><span style=\"background-color: transparent; color: #0e101a; font-family: Arial,sans-serif; font-size: 12pt;\"><i>STEMCELL Technologies provides tools to standardize the CFU assay <\/i><\/span><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 12pt;\"><i>(Source: STEMCELL Technologies)<\/i><\/span><\/figcaption><\/figure>\n<p><span style=\"background-color: transparent; color: #0e101a; font-family: Arial,sans-serif; font-size: 12pt;\">To control variability in CFU assays, standardized and long-term stable reagents should be used. This ensures the consistency and reliability of the assay. A prime example is the&nbsp;<\/span><a href=\"https:\/\/biogroupvietnam.com\/danh-muc-san-pham\/xet-nghiem-nuoi-cay-cum-te-bao-cfu-assay\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"background-color: transparent; color: #1155cc; font-family: Arial,sans-serif; font-size: 12pt;\">MethoCult medium<\/span><\/a><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 11pt;\">, provided by&nbsp;<\/span><a href=\"https:\/\/www.stemcell.com\/\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"background-color: transparent; color: #1155cc; font-family: Arial,sans-serif; font-size: 12pt;\">STEMCELL Technologies<\/span><\/a><span style=\"background-color: transparent; color: #0e101a; font-family: Arial,sans-serif; font-size: 12pt;\"> for over 30 years, which ensures stability and quality for CFU assays. Additionally, standardizing the procedural workflow is crucial by implementing Standard Operating Procedures (SOPs) and ensuring proper training for staff to maintain consistency in technique and analysis. To support this, STEMCELL Technologies offers educational materials and proficiency testing programs to enhance expertise and knowledge. Moreover, the identification and counting of colony clusters &#8211; a highly subjective step in the CFU assay &#8211; should be standardized through rigorous training for manual operators to ensure accuracy and consistency. However, automation is recommended to minimize operator variability, enhance consistency, and expedite data analysis. These measures help reduce variability in the CFU assay, thereby increasing the accuracy and reliability of the analysis results.<\/span> <span style=\"background-color: transparent; color: #0e101a; font-family: Arial,sans-serif; font-size: 12pt;\">Biogroup Vietnam, with our team of experienced experts and support from STEMCELL Technologies, is ready to assist you in standardizing the CFU Assay process to meet international standards.<\/span> <span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 13.999999999999998pt;\"> &nbsp;<strong>Contact Biogroup Vietnam\u2019s consulting experts:&nbsp;<\/strong><\/span><\/p>\n<ul>\n<li><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 12pt;\">Website:<\/span><a href=\"https:\/\/biogroupvietnam.com\/public\/lien-he\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 12pt;\">&nbsp;<\/span><\/a><span style=\"background-color: transparent; color: #1155cc; font-family: Arial,sans-serif; font-size: 12pt;\">https:\/\/biogroupvietnam.com\/public\/<\/span><\/li>\n<li><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 12pt;\">Hotline: +84 963 621 421<\/span><\/li>\n<li><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 12pt;\">Email:&nbsp;<\/span><span style=\"background-color: transparent; color: #1155cc; font-family: Arial,sans-serif; font-size: 12pt;\">info@biogroupvietnam.vn<\/span><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 12pt;\">&nbsp;<\/span><\/li>\n<\/ul>\n<p><a href=\"https:\/\/biogroupvietnam.com\/danh-muc-san-pham\/xet-nghiem-nuoi-cay-cum-te-bao-cfu-assay\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"background-color: transparent; color: #1155cc; font-family: Arial,sans-serif; font-size: 12pt;\"><i>&gt;&gt; Learn more about CFU Assay products<\/i><\/span><\/a> <a href=\"https:\/\/biogroupvietnam.com\/danh-muc-san-pham?organization=stemcell-technologies\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"background-color: transparent; color: #1155cc; font-family: Arial,sans-serif; font-size: 12pt;\"><i>&gt;&gt; Discover more STEMCELL Technologies products<\/i><\/span><\/a><\/p>\n<h2><span class=\"ez-toc-section\" id=\"References\"><\/span><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 20pt;\">References<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 12pt;\">1. STEMCELL Technologies. (n.d.). <i>Homepage.<\/i>&nbsp;<\/span><a href=\"https:\/\/www.stemcell.com\/\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"background-color: transparent; color: #1155cc; font-family: Arial,sans-serif; font-size: 12pt;\">https:\/\/www.stemcell.com\/<\/span><\/a><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 12pt;\">&nbsp;<\/span> <span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 12pt;\">2. Wong, C. (2023, August 31). <i>What to know about hematopoietic stem cells.<\/i> Medical News Today.&nbsp;<\/span><a href=\"https:\/\/www.medicalnewstoday.com\/articles\/285666\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"background-color: transparent; color: #1155cc; font-family: Arial,sans-serif; font-size: 12pt;\">https:\/\/www.medicalnewstoday.com\/articles\/285666<\/span><\/a><span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 12pt;\">&nbsp;<\/span> <span style=\"background-color: transparent; color: #000000; font-family: Arial,sans-serif; font-size: 12pt;\">3. STEMCELL Technologies. (n.d.). <i>Hematopoietic stem and progenitor cells<\/i> [Brochure].&nbsp;<\/span><a href=\"https:\/\/cdn.stemcell.com\/media\/files\/brochure\/BR29054-Hematopoeitic_Stem_and_Progenitor_Cells.pdf\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"background-color: transparent; color: #1155cc; font-family: Arial,sans-serif; font-size: 12pt;\">https:\/\/cdn.stemcell.com\/media\/files\/brochure\/BR29054-Hematopoeitic_Stem_and_Progenitor_Cells.pdf<\/span><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The CFU (Colony-Forming Units) assay ensures the quality of hematopoietic stem cells (HSCs) before transplantation. The CFU assay is used as a standard to assess the potency of HSCs by the FDA, FACT, and AABB. The CFU Assay plays an important role in testing HSCs (Hematopoietic Stem Cells) Overview of Hematopoietic Stem Cells (HSCs) and<\/p>\n<div class=\"klb-readmore post-buttons\"><a class=\"button rounded primary\" href=\"https:\/\/biogroupvietnam.com\/en\/blog\/cfu-assay-evaluation-hematopoietic-stem-cells\/\">Read More <i class=\"klbth-icon-right-arrow\"><\/i><\/a><\/div>\n","protected":false},"author":1,"featured_media":6434,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-4303","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Why is the CFU assay important in testing HSPCs before transplantation?<\/title>\n<meta name=\"description\" content=\"The CFU (Colony-Forming Units) assay ensures the quality of hematopoietic stem cells (HSCs) before transplantation. 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[caption id=\"attachment_6432\" align=\"alignnone\" width=\"1422\"] The CFU Assay plays an important role in testing HSCs (Hematopoietic Stem Cells)[\/caption] Overview of Hematopoietic&hellip;","og_locale":"en_US","og_type":"article","og_title":"Why is the CFU assay important in testing HSPCs before transplantation?","og_description":"The CFU (Colony-Forming Units) assay ensures the quality of hematopoietic stem cells (HSCs) before transplantation. The CFU assay is used as a standard to assess the potency of HSCs by the FDA, FACT, and AABB. 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