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

Abstract

Aim: We sought to determine the safety profile of a therapeutic candidate composed of the released molecules from a combination of human adipose-derived mesenchymal stem cells and fibroblasts. Although stem cells, their progenitor cells and the molecules that are released from these cells have some demonstrated therapeutic value, much more needs to learn about the efficacy, mechanism of action and the safety profiles of these stem cell-based therapeutics. Methods: A number of cellular, in vitro, in vivo and human studies were performed to analyze cellular, tissue and systemic safety profiles of the combinatorial product. Results: At the levels tested in this study, ranging from demonstrated therapeutic doses to supratherapeutic doses, the combinatorial product demonstrated an excellent safety profile in all in vitro, cellular, tissue and systemic studies. Conclusions: We found evidence that a therapeutic candidate composed of the molecules released from human adipose-derived mesenchymal stem cells and human fibroblasts has an excellent safety profile, and that the product warrants further studies for safety and efficacy where dosing may include topical application, injection and oral application.

Mesenchymal Stem Cells as a Cornerstone in a Galaxy of Intercellular Signals: Basis for a New Era of Medicine

“…Preliminary studies suggest safety and efficacy of MSC secretome, where dosing may include topical, intravenous, and oral application [ 155 ]. Products of the secretome could take over from the attempt of therapies based on the administration of growth factors.…”

Stem cells part of the innate and adaptive immune systems as a therapeutic for Covid-19

“…Stem cells and the molecules that stem cells release may be an important new means of developing such antimicrobial therapeutics because the molecules that stem cells release can act in two ways, 1. to inhibit viral replication or entry into host cells, and 2. Resolve the inflammatory damage to host cells that was induced by the virus, the so-called “cytokine storm.” And, being a natural component of the body, these molecules, if chosen from the proper stem cell types ( 26 ), may have few if any negative side effects [ 27 ]. Although premature, stem cell treatments in clinical trials for Covid-19 infections are currently underway in China and the USA, and other locations.…”

“…The use of our proprietary blend of the secretome from ADSCs and their differentiated cell types, fibroblasts, is supported by safety studies [ 27 ] and efficacy data [ 26 ]. Total secretome, not just the extracellular vesicle (EV) fraction, is used because soluble proteins and the EV fractions have been characterized by 384 of 781 proteins being mutually exclusive, and total secretome is more effective than just the EV fraction [ 141 ].…”

“…The molecules naturally produced by some of our stem cells that act as a part of and regulate the immune system, and 2. Feeding the body a diet biased toward plants with soluble and insoluble fiber that will positively renormalize the immune system ( 27 ), both of which will in effect renormalize the immune system to better fight the SARS-CoV-2 virus and quell the ensuing, damaging inflammation.…”

“…The plant based diet will also be a good source of linoleic acid [ 161 162 ], that can induce T-cell function and potentially better clear the infection, and reduce inflammation [ 163 ]. Being careful to control diet as part of one’s exposome, all of the molecules we’re exposed to in life, can increase lung function and immunity [ 164 ], and likely lead to better outcomes in preventing and mitigating the effects of Covid-19 ( 27 ). Because diet affects stem cells function [ 155 ], these same diet strategies may also be important for enabling better endogenous stem cell function important in preventing and mitigating Covid-19.…”