Why ‘Age-Zero tm’ Exosomes are the unquestioned Gold Standard in Regenerative Medicine, Dermatology and Aesthetics Exosome therapy

I am often asked how we chose to invest in creating the manufacturing capability to move "full-tilt" into the production of Medical Grade Exosomes derived from the Wharton's Jelly (WJ) Mesenchymal Stromal (Stem) Cells (MSCs) that we have produced since January 1, 2021 at our Regenerelle Stem Cell (www.regenerellestemcells.com) clean lab facility located in Fairport, NY

The decision to add the production of WJ Exosomes to our WJ Stem Cell business has been one of the best decisions of my entire career as an advanced technology commercialization expert. We are currently, not only the world's largest manufacturer of WJ Stem Cells, but we are also the world's largest producer of WJ Exosomes. Regenerelle tm has approximately 4,000 Quintillion exosomes stored in our NY State Licensed Tissue Bank. We have also increased our exosome yield per umbilical cord from 150 trillion to 250 trillion. That is a LOT of exosomes by any standard.

So why did we move into the medical grade exosome manufacturing and sales business with such intensity - with all our "chips" laid on the Wharton' Jelly exosomes.

The simple reason is that ‘Age-Zero’ Exosomes – the Gold Standard in Regenerative Medicine, Dermatology and Aesthetics Exosome therapy is an emerging area of research that attained tremendous momentum in recent years, a fascinating field that is currently growing exponentially.

Exosomes have wide-ranging applications in clinical translation, but especially so in regenerative medicine, dermatology, and aesthetics.

Exosomes have been shown to promote tissue regeneration and repair, reduce inflammation, enhance recovery from injuries, and have been attributed with significant effects in anti-aging, rejuvenation, and hair regrowth.

However, the field is currently suffering from a great deal of confusion – or perhaps more precisely from a lack of knowledge and education – surrounding the relevance of most suitable or ‘the best’ exosome source, as well as pertinent quality standards applied to exosome products.

Such standards, if at all present or observed, are extremely inconsistent and often not suited for their use in humans, in either clinic or aesthetics.

For the desired characteristics and potential, exosomes derived from stem cells clearly show the most promising results – but even among stem cells, there is a range of applicable options that vary greatly in terms of potency, with stem cells harvested from adipose tissue, bone marrow, or perinatal tissues, to name the three most prominent sources. Stem cells from each of these sources vary in their cellular signature and render them more or less suitable for deriving exosomes, if the goal is to generate the most powerful vesicles.

The one key attribute that stands out in defining the best exosomes attainable, is the trait of truly being ‘age-zero’.

The human body has a remarkable endogenous ability to regenerate and repair itself. However, with age, this capability inexorably wanes away. In fact, we lose a large deal of this ability with the day we are born.

In utero, the potential for repair and regeneration appears to be almost unlimited, but immediately after birth, this is no longer the case. That is why bone marrow or adipose tissue are not an optimal source, even if their donors happen to be healthy individuals in the prime of their life, while ‘age-zero’ stem cells, and exosomes derived from them, by far surpass the potential of any other biological source. Such ‘age-zero’ stem cells are limited to only perinatal sources and can be derived only under strict limitations with regard to manipulation and culture conditions.

Since forming Regenerelle in March 2020, primarily for the initial purpose of reducing the high cost of Medical Grade WJ Stem Cells for the treatment of Covid-19, we focused our manufacturing efforts upon the manufacture and sale of WJ MSCs for medical purposes only. After a year in the WJ MSC global marketplace, we added medical grade WJ Exosomes to our growing list of medical products launched by AT Venture Center, Inc. (atventurecenter.com) including the seven product lines under our Sanatela Medical brands. (www.sanatelamedical.com)

Three months ago, we made the strategic decision to enter the very fast growing marketplace of exosome topical cosmetics - launching our latest brand Resiliélle Cosmetics, LLC. (www.resiliélle.com). When we entered this highly fragmented "Wild West" type marketplace - populated by many relatively small distributors of non-medical grade exosome products of all sorts of exosome source materials and potency (or lack thereof) - most competitors exosome products lacked any sort of third party testing - let alone having medical grade products, This lack of product testing, safety, efficacy and potency is in fact the topical cosmetic norm - despite the obvious risks of applying an untested product to skin that had just been treated by microneedling or laser.

Non-medical grade topical exosome cosmetics products are even being used by professionals in the industry who have often been told that medical grade exosome products are unnecessary.

?More About Age-Zero tm Science

After the age of 20, a person produces about 1 percent less collagen in the skin each year. As a result, the skin becomes thinner and more fragile with age.

The natural nanoparticles (Exosomes) in our?RESILIéLLE?tm products are derived from Wharton's Jelly Human Umbilical Cord Mesenchymal Stem Cells. In peer reviewed scientific studies, exosomes derived from Age-Zero Wharton's Jelly, Human Umbilical Cord Mesenchymal Stem Cells outperform exosomes derived from adult adipose tissue stem cells and adult bone marrow tissue stem cells.

Why is that? As we humans age, so too do our stem cells. There is no tissue stem cell source more potent than Wharton's Jelly of the Human Umbilical Cord. Studies show that Age-Zero WJ-MSC exosomes signal and?communicate to your skin stem cells, fibroblast to revitalize and optimize collagen production. Harnessing these natural?signaling?abilities of Age Zero exosomes, RESILIéLLE exosomes - when applied topically - communicate with your skin stem cells, providing a trigger to 'resiliere in tempore' tm.?

Exosome Excellence tm

RESILIéLLE's?standards are a quantum leap above and beyond the traditional cosmetic industry standards into a high-end class of its own.

RESILIéLLE?Exosomes are?manufactured using human Mesenchymal Stromal/Stem Cells (MSCs), harvested from a single umbilical cord per each batch of Exosomes.?

WJ-MSCs are specifically selected early in the harvesting process to ensure the efficient production of uncontaminated highly potent cells. All donor tissue is screened for pathogens and tested to ensure that it is negative for communicable diseases, plus each?RESILIéLLE?vial is confirmed to be contaminant free and sterile. Each shipment is sent with a comprehensive?Certificate of Conformity ?to guarantee that each lot is?tested thoroughly for safety and quality to clinical grade standards.

At last the MedSpa, Dermatology and Plastic Surgical marketplace has an exosome product Physicians and Clinicians can trust.