Transforming regenerative medicine procedures into manufacturing processes

The current research improves an original procedure of in-vitro, strain-stimulated skin expansion, which has been shown to be a potential treatment for severe burn victims [1]. This regenerative medicine procedure involves grafting partial thickness skin from the patient, expanding it in-vitro over several days with a strain imparting device in a tissue culture condition, and transplanting it back to the patient thereby doubling the treatment efficacy of a single graft without the undesired mesh scarring associated with the current comparable treatment. This research examines the in-vitro, biological procedure with uncontrolled variability and seeks methods to create a repeatable, controlled manufacturing process with defined quality control parameters and predictable input-output relationships. To this end, the attachment of skin to a strain-inducing bioreactor has been improved, and the process of skin expansion is currently being studied to identify quality control parameters. In overview, this research develops a method for transforming uncontrolled biological procedures into reproducible, controlled manufacturing processes.