From raw materials to stem cell clinics: The call for better standards and regulations

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We have previously, in this blog and public forums, drawn attention to the growing need for better standardization of cell therapies – from raw materials through to manufacturing and clinical administration.

Efforts on the part of various standardization bodies have increased in recent months, with a growing number of initiatives aimed at streamlining cell therapy processes.

While unlicenced stem cell clinics have been the subject of extensive write-ups in other media, and while the remit of standardization agencies does not necessarily cover these clinics, high-profile reports about these are worth paying attention to as they touch on the very real need for improved standardization efforts across the board.

A recent public call for the FDA to act upon these clinics was published recently in the New England Journal of Medicine. Drs. Hermes Taylor-Weiner and Joshua Graff Zivin called for the FDA to act upon unlicenced stem cell therapies by clarifying their position on legislation that is ambiguous.

A big point of contention, at least in the paper, appears to be administartion of stem cells from adipose (fat) tissue, which are collected by liposuction and called stromal vascular fraction (SVF). The degree of processing and manipulation is key here.

The FDA has recently issued draft guidance stating that SVF cells are likely to fall into a category of product that requires strict oversight and official approval for use in patients, adding that warning and guidelines will be issued to doctors administering such treatments.

Obtaining, processing and administering SVF stem cells touches on multiple steps in the cell therapy process – efforts at standardization cover every aspect of the stem cell therapy process.

Akron has been a proponent of standardization in the industry. We work with multiple industry bodies to try and streamline the steps involved in the cell therapy process and will continue to do so.

If you would like to talk to us about issues that involve standardization, traceability and process development, contact us.

 

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