Cryopreservation of implantable human skeletal muscle-derived cell-microcarrier combinations for use in clinical regenerative medicine.

Abstract

Background aims: Regenerative medicine therapies include tissue-engineered constructs to restore tissue and organ function. Among the different approaches, implantable polymeric microcarriers have been proposed for delivery of anchorage-dependent cells to target tissue locations. Cell-microcarrier combinations produced as fresh advanced therapy medicinal products face significant challenges in terms of manufacturing and time distribution. In the current study, we have explored the feasibility of cryopreservation for human skeletal muscle-derived cells (SMDC)-implantable microcarrier combinations.

Methods: Existing and novel cryoprotectant formulations combined with slow cooling were investigated, along with rapid and slow thawing regimens.

Results: Under specific conditions after cryopreservation and thawing, most SMDC cells were viable and remained attached to the microcarriers. Furthermore, the capacity of human SMDCs to differentiate into myotubes was unaffected. The cryopreservation process did not alter the physico-mechanical properties of the microcarriers enabling them to retain their primary function of an implantable cell substrate.

Conclusions: Overall, these findings pave the way to use cold-chain product supply for future clinical studies with the implantable cell-microcarrier technology.