I am not referring to Shakespeare’s Macbeth nor to Kurt Vonnegut’s short story. My knees and hips are tired of waiting for the FDA to approve the Personalized Stem Cell Clinical Trial. I am moving forward with an alternative option that should and could provide me symptom relief and improved function; yet not preclude me from the adipose-based clinical trial, if and when, approved by the FDA.
From the Personalized Stem Cells Blog
“The U.S. FDA development steps required for a stem cell product approval
Aug 19, 2022
American patients have access to the safest and most advanced healthcare and pharmaceutical system in the world.1 But, to be able to market a drug treatment for therapeutic use in the United States, U.S. Food and Drug Administration (FDA) approval is required. Other countries have similar regulators, but most fall short of the United States FDA standards. Before granting an approval, the FDA requires that sponsors like Personalized Stem Cells, Inc. conduct escalating stages of clinical trials to demonstrate the safety and efficacy of their drug.”
You may read the blog in its entirety at: https://personalizedstemcells.com/the-u-s-fda-development-steps-required-for-a-stem-cell-product-approval/
In my blog, I will attempt to explain the science behind my interim choice of options.
THE MESSENGERS
Extracellular Vesicles (EV’s) consist of exosomes and microvesicles, which are released directly from the cell membrane. EV’s can mediate cell–cell communication and are involved in many processes, including immune signaling, angiogenesis, stress response, senescence, proliferation, and cell differentiation. EV’s are involved in restoring tissue and organ damage, and may partially explain the paracrine effects observed in stem cell-based therapeutic approaches. The function and content of EV’s may also harbor information that can be used in tissue engineering, in which paracrine signaling is employed to modulate cell recruitment, differentiation, and proliferation.
GROWTH FACTORS & CYTOKINES
Growth factors are proteins that may act locally or systemically to affect the growth of cells in several ways. Various cell activities, including division, are influenced by growth factors. Cytokines are a family of low-molecular-weight proteins that are produced by numerous cell types and are responsible for regulating the immune response, inflammation, tissue remodeling, and cellular differentiation. Target cells of growth factors and cytokines are mesenchymal, epithelial, and endothelial cells. These molecules frequently have overlapping activities and can act in an autocrine or paracrine fashion. A complex network of growth factors and cytokines guides cellular differentiation and regeneration in all organs and tissues.
PARACRINE SIGNALING
Paracrine signaling is a form of cell-to-cell communication in which a cell produces a signal to induce changes in nearby cells, altering the behavior of those cells. Signaling molecules known as paracrine factors diffuse over a relatively short distance (local action), as opposed to endocrine factors (hormones which travel considerably longer distances via the circulatory system), juxtacrine interactions, and autocrine signaling
Forging Ahead in 2022 Along the Path of Innovation
I still am looking forward to the adipose-based, stem cell, clinical trial; but the fall fly fishing season is almost here, the cycling season continues, and winter skiing is on the horizon. Given our outcomes data on biologics in general, a minimum of three months need to be anticipated for the biologic application to prove beneficial. To learn more, visit my website at www.sheinkopmd.com. Even better, call and schedule a consultation at (312) 475-1893.