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STEMCELL Technologies, Inc. announced today the launch of three new STEMvision™ CFU Assay Analysis Packages designed to accurately identify, classify and count hematopoietic colonies in 14-day CFU assays of human umbilical cord blood (CB), bone marrow (BM), and mobilized peripheral blood (MPB) cells.
Automated and standardized CFU counting relies on a platform of multiple products developed by STEMCELL Technologies Inc., that are all immediately available for use by cord blood banks, transplant and research laboratories. These products include:
• STEMvision™, a bench-top instrument and computer system for automated imaging and counting of hematopoietic colonies in the CFU assay;
• Three new software Analysis Packages designed to separately count total, erythroid, myeloid and mixed-lineage CFUs in conventional 14-day assays of human CB, BM and MPB cells;
• MethoCult™ culture media to support optimal proliferation and colony formation by hematopoietic progenitor cells;
• HetaSep™, to deplete red blood cells from fresh samples prior to CFU analysis;
• SmartDish™, meniscus-free cultureware for more reliable colony counting.
Automated hematopoietic colony counting with STEMvisionTM is faster and more reproducible than manual counting using an inverted microscope. This saves time in staff training and laboratory workflows, and minimizes intra- and inter-individual and laboratory variation in colony counting. The overall result is a standardized assay system that ensures accurate CFU assay results. This new automated system also allows permanent record keeping of digital culture images and data review in an easy-to-use format.
Automated colony counts using STEMvision™ are highly correlated with manual counts of the same cultures scored by trained scientific personnel. Correlation coefficients (r2) range from 0.88-0.98 for total CFUs in different assays. Importantly, colony counts produced by STEMvision™ exhibit a significantly lower coefficient of variation (CV) than manual counts; e.g., CV = 5% for total colonies in a 14-day CFU assay of CB vs. ≈ 25% as reported for NMDP laboratories1.
“Researchers have needed a more standardized assay to measure the number of stem and progenitor cells in human tissues. One of the most important applications of this technology is to measure the number of CFUs in hematopoietic cell grafts to determine their potency prior to transplantation. No other widely established phenotypic or functional assay for measuring hematopoietic stem and hematopoietic progenitor cells has been shown to correlate as well with engraftment outcomes as the CFU assay” said Dr. Stephen Szilvassy, Associate Director of Hematopoietic Products R&D at STEMCELL Technologies Inc. “For example, several studies have shown that the total number of CFUs in cryopreserved cord blood units after thawing is the single best independent predictor of neutrophil and platelet engraftment, and overall survival following allogeneic cord blood transplantation2-6.”
The new 14-Day CFU Assay Analysis Packages significantly expand the capabilities of the STEMvision™ system. A fourth Analysis Package specifically designed for CB banks allows the total number of viable and functional CFUs in a CB unit to be measured in only 7 days. This is one week faster than with the conventional 14-day CFU assay and may facilitate decision-making around the time of transplantation. Dr. Szilvassy: “The 7-day CFU Assay Analysis Package really simplifies the CFU assay, and further facilitates standardization. Since the clinical data show that it is the total number of CFUs in a CB unit that correlates with engraftment, there really is no need to measure the different CFU sub-types in this application”.
About STEMCELL Technologies, Inc.
STEMCELL Technologies, Inc. (stemcell.com) is a leader in the development and marketing of specialty cell culture media, cell separation products and ancillary reagents for life science research. Driven by science and enabled by close interactions with global leaders in cell biology and medicine, STEMCELL delivers over 1000 products to research scientists in more than 70 countries worldwide.
Literature cited
1. Spellman S, Hurley CK, Brady C, et al. Guidelines for the development and validation of new potency assays for the evaluation of umbilical cord blood. Cytotherapy 13:848-855, 2011
2. Migliaccio AR, Adamson JW, Stevens CE, et al. Cell dose and speed of engraftment in placental/umbilical cord blood transplantation: Graft progenitor cell content is a better predictor than nucleated cell quantity. Blood 96:2717-2722, 2000
3. Iori AP, Cerretti R, De Felice L, et al. Pre-transplant prognostic factors for patients with high-risk leukemia undergoing an unrelated cord blood transplantation. Bone Marrow Transplantation 33:1097-1105, 2004
4. Yoo KH, Lee SH, Kim HJ, et al. The impact of post-thaw colony-forming units-granulocyte/macrophage on engraftment following unrelated cord blood transplantation in pediatric recipients. Bone Marrow Transplantation 39:515-521, 2007
5. Prasad VK, Mendizabal A, Parikh SH, et al. Unrelated donor umbilical cord blood transplantation for inherited metabolic disorders in 159 pediatric patients from a single center: Influence of cellular composition of the graft on transplantation outcomes. Blood 112:2979-2989, 2008
6. Page KM, Zhang L, Mendizabal A, et al. Total colony-forming units are a strong independent predictor of neutrophil and platelet engraftment after unrelated umbilical cord blood transplantation: A single center analysis of 435 cord blood transplants. Biol Blood Marrow Transplant 17:1362-1374, 2011.
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