The field of stem cell therapy has exploded recently. Much excitement has been generated over growing evidence that various stem cell populations have potential to differentiate into most cell types found in the body, thus providing the first source of replacement cell and tissue therapy.
The challenge has been converting these bench-top observations into commercially feasible, and near-term clinically significant products. One of the biggest problems has been obtaining large enough numbers of functional cells for clinical use. While cell lines generated from embryonic stem cells might provide an expandable source of therapeutic cells, political and ethical debates have limited research in this area.
Adult stem cells isolated from human bone marrow or peripheral blood can provide a good alternative source of therapeutic replacement cells. Up to now, a major obstacle has been obtaining the right kind of stem cell population for tissue regeneration application in large enough numbers to produce the desired therapeutic effect.
Different companies have struggled to design culture conditions that allow the expansion of adult stem cell populations without changing their ability to differentiate fully into all cell types. To date, no company has been successful.
ALDAGEN has taken a different approach. The Company's technology is the only one able to isolate from a patient's bone marrow a potent population of therapeutic cells including all of the stem and progenitor cell types needed for optimal cell therapy.
ALDAGEN's proprietary products identify, select and isolate adult stem cells that express high levels of the intracellular enzyme aldehyde dehydrogenase (ALDH). The central component in the ALDESORT product is a proprietary substrate for ALDH that makes cells with high ALDH activity give off a green fluorescence. These cell populations are referred to as "ALDH bright" (ALDHbr) because they fluoresce intensely. ALDESORT also includes reagents to optimize the reaction. The intracellular fluorescence is detected using a cell sorter that allows ALDHbr cells to be isolated from other cells. ALDAGEN's technology is supported by multiple peer-reviewed publications, and is protected by a growing portfolio of issued patents and patent applications covering methods to identify, enumerate, isolate and use cells with high ALDH activity.
