Stem Cell "Quality", Potency and Patient Monitoring Assays that are Comparable, Equivalent and can Replace Traditional Colony-Forming Assays
Download the Quality Control Brochure here.
HemoGenix® considers quality control in stem cell transplantation and cord blood storage of paramount importance. In particular, the purpose of a stem cell transplant is to replace the damaged blood - forming system with a new and viable blood-forming system. If the cells being transplanted cannot grow by proliferating, they are of no use to the patient.
If stem cells cannot proliferate, no engraftment or reconstitution will take place. Therefore, assays are required that measure proliferation potential (potency/strength) and/or status.
Assays are also required to measure time to engraftment and to monitor lympho-hematopoietic reconstitution after transplantation.
As of October 20, 2009, umbilical cord blood is considered a drug by the FDA. Cord blood banks must submit a Biologics License Application (BLA) by October 2011 containing results showing, among other things, assay validation.
The FDA allows the "use of an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations".
All HALO® assays for stem cell "quality", potency and patient monitoring are comparable, equivalent and validated to comply with the regulations.
The diagram below shows all of the HemoGenix® assay kits for stem cell quality control, potency and release and patient monitoring, including those for Mesenchymal Stem Cells.
To download a copy of this Platform Summary diagram, click here
