The Safety of a Therapeutic Product Composed of a Combination of Stem Cell Released Molecules from Adipose Mesenchymal Stem Cells and Fibroblasts

Abstract

Stem cell transplants have demonstrated life-saving capabilities for some blood diseases, and the molecules and exosomes released from stem cells are currently in therapeutic development for a number of diseases and conditions, including neurodegenerative diseases, heart conditions, glaucoma, hearing loss, and skin diseases. Stem cell science is a relatively new science, and therapeutic development using stem cells, even approved stem cell therapies for blood diseases, is in need of a better understanding of mechanisms of action and acute and long-term safety profiles. Here we performed a number of safety tests for a stem cell-based therapeutic comprised of the stem cell released molecules from a combination of adipose derived mesenchymal stem cells and fibroblasts that have demonstrated efficacy in a number of conditions. Using in vitro, in vivo, and skin sensitivity studies in humans, the stem cell therapeutic comprised of stem cell released molecules was shown to have an excellent safety profile when tested for toxicity, mutagenicity, tumorigenesis, ocular toxicity, inflammation, and irritation.