Step 1: Mesenchymal Stem Cells (MSCs)
Adult MSC’s are obtained by human bone marrow aspiration from healthy screened donors, typically between 20-25 years old. The process is painless and whatever the donor gives is regenerated within a matter of days.
The resulting documented 500,000 MSC’s are used by RxESCUESKIN to begin producing our stem cell derived
Step 2: Culturing (growing) MSCs to produce stem cell derivatives
Starting with 500,000 MSC’s (about 16 oz - can of coke) we culture these MSC’s through 10 passages, equaling 30 cell doublings in tissue culture flasks. This takes about 3 months and is monitored daily by a team of scientists.
Those initial 500,000 cells become 10,000,000,000,000 (10 trillion). To put this into perspective, say, for example, each MSC is 10 microns in diameter (or about 10x smaller than a grain of sand). If each MSC was to be lined up side by side, the 9.8 trillion cells would stretch 60.9 miles.
That produces roughly 195 liters of stem cells. We then remove those cells using various very small filters. The MSC are not extracted or broken open. Instead exosomes, peptides, proteins, cytokines and enzymes that were released during their growth are collected using even smaller filters and become the basis for our stem cells derived actives.
Step 3: Quality Control and Skin Cell Testing
Even though the cells have all ready passed numerous tests for safety, we repeatedly. conduct microbiology at every growth stage, as well as nutrient and metabolic testing to ensure electrolytes, glucose, glutathione, glutamate, lactate, ammonia and LDH are at acceptable levels. Cell morphology (or how the cells look and function) is also examined at every tissue culture media change and passage.
Finally we perform something known as a "functional challenge" against American Type Tissue Culture sourced human dermal fibroblasts to ensure our cells and their derivatives are of the best quality. The functional challenge test is also referred to as a "gap assay" in which our stem cell derived media is used to culture (grow) two separate human dermal fibroblast (skin) cell lines in Petri dishes. Once the cells and our media have been combined in the Petri dish we draw a gap using a swab. The gap replicates what would happen if the skin was cut or damaged. We then measure how quickly the gap is filled which includes growth rates of the human dermal fibroblasts as well as pro-collagen production. THIS IS ONE OF THE THINGS THAT MAKES OUR PRODUCT SO UNIQUE.
A Biological Master File has been accepted by the Food & Drug Administration (FDA) that includes the proprietary components of the production media, the source of cells, the tissue culture procedures and the multiple tests run throughout this process as well as the test results.