1.1 This guide outlines the parameters to consider when designing in-vitro tests to assess the potential impact of a delivery device on a cellular product being dispensed. This guide does not provide specific protocols, but rather suggests what should be considered the minimum characterization necessary to qualify a medical device as cytocompatible with delivering therapeutic cells. Topics discussed include selecting an appropriate cell line(s), cell physiology parameters to measure, and relevant test procedure variables. Only cells suspended in liquid and infused through a device are considered. Cell therapies paired with scaffolds, suspended in hydrogels, or administered via other methods (for example, tissue grafting) are not included in the scope of this guide. 1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
The users are those who will manufacture devices used to deliver cell therapy products, such as catheter manufacturers. This 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 are 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.
Keywordscell therapy; medical device; cell compatibility; stem cells; cytocompatibility; catheter
The title and scope are in draft form and are under development within this ASTM Committee.Back to Top
Ballot Item Approved as F3206-2017 and Pending Publication