ALDAGEN’s proprietary technology can identify, select and isolate adult stem cells that express high levels of the intracellular enzyme aldehyde dehydrogenase (ALDH). The central component of this technology 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. The stem cell marker technology 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.
ALDAGEN's patented technology has several key advantages when compared to other methods for isolating therapeutic stem cell populations. Those advantages are:
Isolates a heterogeneous mix of stem and progenitor cells
The Company's technology identifies a heterogeneous mix of stem and progenitor cells, including hematopoietic, mesenchymal, endothelial and neural, which predict a broad range of clinically relevant activity will be available for study by clinicians who use ALDAGEN's products. Thus, unlike technologies aimed at selecting or expanding one specific population of cells, ALDESORT gives an array of progenitor cells and also the cells that may support the growth and differentiation of progenitor cells into different tissue types at sites of damage. There is growing belief in the clinical community that infusing a mix of progenitor cells and the cells that support their growth and development in injured tissues is the most effective approach for regenerative medicine applications.
Isolates all the active stem cell progenitors in one sorting procedure
ALDAGEN's technology allows the sorting of this heterogenous stem cell population in one sorting step. The Company has designed this cell-sorting process that starts with a patient's bone marrow sample, sorts for a single, proprietary enzymatic marker, and isolates a therapeutic cell population that can be infused back into the patient within one day of marrow harvest.
Isolated cells do not require culturing before therapeutic infusion
ALDAGEN believes that the ALDHbr cell population identified with its technology will not require additional culturing before reinfusion for many important indications including cardiovascular therapy thus simplifying regulatory and logistical issues with therapy. In other indications, such as the cord blood transplant clinical study, isolating cells with ALDESORT will provide a defined stem cell input to culture protocols which the Company is investigating to see if they will lead to more reproducible results.
Isolated cells are more therapeutically active than bone marrow mononuclear cells
The ALDHbr cell population has been shown in a preclinical model of vascular disease to be even more therapeutically active than whole bone marrow. Bone marrow has already shown clinical promise in multiple clinical trials. This suggests that ALDAGEN's technology may be removing inhibitory factors or competing cell types from the therapeutic cell population.
Isolates only viable cells
Only functionally viable cells with intact cell membranes are measured and collected by ALDESORT. Dead or leaky cells are not sorted. Therefore, ALDAGEN's products will give only viable cells for therapy whereas other cell sorting methods allow some percentage of nonviable cells to be included in the cell product for reinfusion.
