![]() cGMP - The DomaniCell Advantage can be Yours We at DomaniCell believe in the importance of storing cord blood stem cells in a manner which exceeds most current industry standards for existing therapies. Let us explain... The FDA governs the collection, processing, storage, and clinical use of cord blood stem cells. There are two levels of standards which apply: cGTP and cGMP. All cord blood banks must be compliant with cGTP standards. Most cord blood banks in the USA are satisfied with cGTP compliance because current therapies such as stem cell transplantation using cord blood stem cells are simple enough they fall within the cGTP category. The higher cGMP standard, however, is required for more complex cell therapies presently in clinical trial and being developed as future therapies such as those in current clinical trails for Alzheimer’s, Multiple Sclerosis, Diabetes, spinal cord injury, Lupus, and many other diseases. Of course cord blood stem cells banked under cGTP are perfectly suitable for today's therapies, such as stem cell transplantation. But we at DomaniCell believe that cGMP-compliant cord blood banking will be critical to the use of these stem cells in many of the more complex future therapies presently being developed. We would be happy to provide you with links to recent FDA publications which we believe support this point. There are now a small number of leading-edge cord blood banks which require all their cord blood units to be banked in cGMP compliance. We simply believe that if, for the same price, parents could choose to store their child’s umbilical cord blood stem cells under cGMP and thereby not limit the future potential use of those cells in more complex therapies based on cord blood stem cells, this would be an advantage worth taking. Those using DomaniCell are assured of the strictest compliance with cGMP because cGMP production of cell-based products is the primary business of our parent company, Progenitor Cell Therapy, which performs all our cord blood and storage. Progenitor Cell Therapy’s management team has over 120 years combined experience in cell therapy. The company has served over 100 leading organizations including stem cell banks, academic stem cell transplant and clinical cell therapy programs, and companies developing cell therapy products. We have worked with over 20 different types of cells and created over 17,000 cell therapy products approximately 5,000 of which have already been used for treatment of genetic, infectious, cardiovascular, neuronal, corneal, and orthopedic diseases, immune system failure, cancer, ulcers, burns, etc. Based on our experience in manufacturing cell therapy products for clinical trials or commercial distribution and our interactions with FDA, we believe that cGMP-grade raw materials, including the cells, will be required for many of the future cellular therapies presently in development. Why risk limiting the potential use of those cord blood stem cells even before they are stored? For those wanting to maximize the potential future therapeutic use of stem cells being stored today, bank with DomaniCell. Banking stem cells the right way. © 2008 DOMANICELL. All rights reserved. New Jersey, USA. Cord blood banking and umbilical cord blood storage. Back to Web Layout |