Products
STEMpredict™
The most rapid assay to predict viability, growth and cellular functionality of stem cells in mobilized peripheral blood, umbilical cord blood and bone marrow products manufactured in a stem cell processing laboratory.
Available as assay kits and contract research services.
Applications
- Rapid assessment (3 days assay) of hematopoietic stem cell product viability, growth and cellular functionality in a single assay.
- Specifically designed for mobilized peripheral blood, umbilical cord blood or bone marrow products.
- Is a cord blood unit bankable?
- Is a mobilized peripheral blood unit useable?
NOTE: Although the community norm is to use the colony-forming unit (CFU) assay, such as CAMEO™-4, an equivalent and alternative assay, such as STEMpredict™ is acceptable by the FDA, since it satisfies "the requirements of the applicable statutes and regulations". In addition, AABB Standards for Cellular Therapy Services also allows "equivalent functional assays for any product", and the National Marrow Donor Program (NMDP) allows testing "consistent with AABB Standards".
Why Use STEMpredict™ in the Stem Cell Processing Laboratory?
- STEMpredict™ is the only indicator of stem cell viability, growth and cellular functionality for mobilized peripheral blood, umbilical cord blood or bone marrow for transplantation purposes.
- Results in 2-3 days. No other stem cell processing laboratory tool exhibits the sensitivity to demonstrate cellular functionality so rapidly.
- STEMpredict™ incorporates proven bioluminomics™ technology for highly sensitive, fast and reliable results.
- Bioluminomics™ technology in STEMpredict™ assays allows for assay calibration and standardization and, if required, validation.
Tissues used with STEMpredict™
- Mobilized peripheral blood
- Umbilical cord blood
- Bone marrow
- Purified cells from any of the above
Click image for larger view
STEMpredict™ for Cord Blood Stem Cells
The graph shows an example of how STEMpredict™ predicts stem cell growth, functionality and viability for umbilical cord blood cells. If cells are metabolically viable (which is not the same as being viable by dye exclusion methods), they will demonstrate cellular and mitochondrial integrity by producing intracellular ATP (iATP). The iATP concentration, in turn, directly correlates with proliferation ability. If a quantitative difference in proliferation ability between stimulated and unstimulated (background) stem cells exists, as shown in the graph, the stem cells from the product are predicted to proliferate and grow. In this way, STEMpredict™ not only detects whether the cells are metabolically viable, but also whether they will exhibit cellular functionality and proliferate. The assay therefore measures three parameters simultaneously.
This same concept and principle is applied to mobilized peripheral blood, bone marrow and purified hematopoietic cell products. It is also the cornerstone of all HemoGenix® cellular therapeutic assay kit products, including HALO®-96 PCAEQ, HALO™-96 SPC-QC, HALO™-96 PMT, LUMENESC™-96 HuQC and LUMENESC™-96 PQR.
Use
For Research Use Only. Not for clinical diagnostic use.
Kit Contents
- STEMpredict™ Master Mix
- ATP standard
- ATP high and low controls
- ATP Enumeration Reagent
- Sterile, 96-well plates for cell culture
- Non-sterile 96-well plates (for assay calibration and standardization)
- Sterile, adhesive foil covers to maintain sterility in unused wells
- Instruction manual