The guide will outline the parameters to consider when designing benchtop tests to assess the potential impact of the delivery device on the cellular product being dispensed. The first section of the document will outline what constitutes an acceptable representative cell type(s) or reporter cell system if using device extracts. The next section will outline what parameters of cell physiology should be measured to make a determination of cytocompatibility; this and the first section will form the bulk of the document. A final section will outline the thinking on testing components individually or as assembled for delivery, use of worst case setups (e.g. large volume syringe on small gauge needle), delivery device exposure conditions (e.g., time, surface area contact), appropriate density of cells to use during test, and other similar items.
The users are those who will manufacture devices used to deliver cell therapy products, such as catheter manufacturers. The standard is needed to assess the effects of delivery devices on cell function. Catheter manufacturers have found that catheter properties can influence performance of delivered cell therapy products. However, there is wide variability in how delivery device effects on cell performance is evaluated. This standard will help eliminate this confusion and provide guidance to manufacturers on how to measure the effects of their device on delivered cells.
Keywordsstem cell:cell therapy products:regenerative medicine:catheter:medical device
The title and scope are in draft form and are under development within this ASTM Committee.Back to Top
Draft Under Development