Does the NDPL Process Include Cell Expansion?

For important reasons, NDPL does not expand your dental pulp stem cells. FDA guidelines mandate that we adhere to the requirement of ‘minimal manipulation’ during processing; essentially, we must not manipulate your dental pulp any more than what is required to properly prepare it for cryogenic storage. This includes the process of cell expansion, a process that the FDA considers as ‘more than minimally manipulated.’

Cell Expansion for Verification

Other dental stem cell banks may offer expansion of at least a portion of your dental pulp stem cells, in order to verify that that the sample is viable. We do not offer that service, for three key reasons:

• If we did expand a small portion of your dental pulp stem cells for verification, and then freeze the rest upon verification that the culture expanded, we would be jeopardizing the quality of your tissue sample. The average dental pulp sample is very small in size, with a small number of stem cells. By expanding a portion of it, we are unnecessarily reducing the number of stem cells that can be stored. Any tissue used for testing purposes would be lost.
• Per FDA guidelines, we would not be able to store any tissue that we expanded. Expanded stem cells are regulated different than unexpanded stem cells, as they are more than minimally manipulated. If expanded cells were stored, the unit could be rendered unusable in the future.
• Additionally, cell expansion introduces other risks such as viruses and pathogens, or even losing their potency during expansion. Our goal is to process your dental pulp stem cells with the least amount of manipulation, leaving them in their most pristine state.

Processing and Storage