Rich I.N.,HemoGenix Inc
Stem Cells Translational Medicine | Year: 2015
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 aUCB stem cell transplantwithout 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 themononuclear cell fraction and that new cost-effective technology thatmeasures the quality and potency of UCB stem cells be implemented to achieve better practices in UCB testing. These changeswould provide the transplant physician with the assurance that the stem cellswill perform as intended and would reduce risk and increase safety and efficacy for the patient. © AlphaMed Press.
HemoGenix Inc. | Date: 2007-06-19
Research and quality control kits consisting primarily of luminescence reagents for scientific or research use and tissue culture needed for culturing, growing and detecting blood-forming cell populations from different animal species for basic and clinical research, drug development and environmental research; research and quality control kits consisting primarily of luminescence reagents for medical laboratory use and tissue culture needed for culturing, growing and detecting blood-forming cell populations from different animal species for basic and clinical research, drug development and environmental research. quality control kits consisting primarily of luminescence reagents for clinical use. laboratory services, namely, testing drugs and compounds for their effects on the blood-forming system.
Patterson J.,University of Colorado at Colorado Springs |
Moore C.H.,University of Colorado at Boulder |
Palser E.,University of Colorado at Colorado Springs |
Hearn J.C.,HemoGenix Inc |
And 3 more authors.
Journal of Translational Medicine | Year: 2015
Rare hematopoietic stem cell populations are responsible for the transplantation engraftment process. Umbilical cord blood (UCB) is usually processed to the total nucleated cell (TNC), but not to the mononuclear cell (MNC) fraction. TNC counts are used to determine UCB unit storage, release for transplantation and correlation with time to engraftment. However, the TNC fraction contains varying concentrations of red blood cells, granulocytes, platelets and other cells that dilute and mask the stem cells from being detected. This does not allow the quality and potency of the stem cells to be reliably measured. Methods: 63 UCB segments and 10 UCB units plus segments were analyzed for the response of both primitive lympho-hematopoietic and primitive hematopoietic stem cells in both the TNC and MNC fractions. The samples were analyzed using a highly sensitive, standardized and validated adenosine triphosphate (ATP) bioluminescence stem cell proliferation assay verified against the colony-forming unit (CFU) assay. Dye exclusion and metabolic viability were also determined. Results: Regardless of whether the cells were derived from a segment or unit, the TNC fraction always produced a significantly lower and more variable stem cell response than that derived from the MNC fraction. Routine dye exclusion cell viability did not correspond with metabolic viability and stem cell response. Paired UCB segments produced highly variable results, and the UCB segment did not produce similar results to the unit. Discussion: The TNC fraction underestimates the ability and capacity of the stem cells in both the UCB segment and unit and therefore provides an erroneous interpretation of the of the results. Dye exclusion viability can result in false positive values, when in fact the stem cells may be dead or incapable of proliferation. The difference in response between the segment and unit calls into question the ability to use the segment as a representative sample of the UCB unit. It is apparent that present UCB processing and testing methods are inadequate to properly determine the quality and potency of the unit for release and use in a patient. © Patterson et al.; licensee BioMed Central.