Episode Transcript
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Dr. Kay Durairaj (00:15):
well, hello,
hello, guys. You're listening to
beauty bites with Dr K secretsof a plastic surgeon. And it's
time for a really interestingpodcast. I know you guys have
heard the buzzword exosomes.Exosomes are everywhere in
esthetics, in your DERM office,your plastic surgery office, and
we have two really amazingexperts today. We're going to
(00:35):
talk about all the red flags andall the safety issues you should
be aware of with exosomes thatare on the market. So I want to
welcome Erin Crowley and Dr Mikeheckay, and we are going to talk
in detail. Erin is a globalleader in regenerative
Biotherapeutics. She's co chairof the exosm Exact oversight
Bureau and CO manager of theCrowley center for Regenerative
(00:58):
Biotherapeutics. So she has morethan 15 years of experience in
the corporate world, engineeringand regulatory compliance, and
she's bringing those goldstandards into esthetics. This
year, she's really worked onpioneering a new era of purity,
functionality, transparency, andreally looking at what makes a
gold standard for an exosome interms of exosome quality. So
(01:22):
she's at the helm of thisexosome exact oversight Bureau,
which we're going to hear moreabout. And Dr Mike Heke started
his career in pharma researchingwith Bayer, and he has been a
stem cell researcher since theyear 2000 and did stem cell work
in heart failure. He was alsoscientific coordinator for many
large scale EU projects. Hefounded the German stem cell
(01:45):
network, and he joinedRockefeller University to lead
his department of stem cellbiology. He was appointed deputy
to the president of StanfordUniversity, managing Bing's
presidential laboratory. And healso is currently at the Crowley
center for RegenerativeBiotherapeutics, and they focus
on kind of bringing stem cellscience safely and effectively
(02:05):
into regenerative medicine. Sowith that huge intro, you guys
know you're listening to someexperts. Welcome, welcome Aaron
and Mike. Thank you so much.Well, I want to dive right in
and talk a little bit about whatis an exosome? Aaron, maybe you
can explain to me in layperson'sterms. Since many people have
(02:27):
heard the word exome, butprobably couldn't define it,
tell me how we should think ofwhat is an exosome.
Erin Crowley (02:33):
So exosomes come
from lots of different sources,
and an exosome is a little nanobubble, 30 to 150 nanometers.
Super, super tiny. They'resecretions of stem cells. Stem
cells also secrete hyaluronicacid, collagen type four.
Axosomes are another secretion,and inside these axosomes are
(02:55):
incredible rich ingredients, allthe things we love for our skin
and hair, intimate tissues, youname it, they're great so
collagen inducing, so fromfunctional proteins, growth
factors, ceramides. But whatmakes an exosome so totally
different than a growth factoror a bio stimulator is that this
(03:19):
little nano bubble, it travelsto damaged tissue, and it's
captured. And when it'scaptured, it delivers all of
those rich ingredients I talkedabout, that basically restore
the cell. But also happens, andI'm not a biologist background,
so what I've learned is it alsocarries micro RNA, and that
micro RNA sends a message, andthe cell decodes it, and just
(03:43):
like a computer, it reboots. Sowhen you use age zero exosomes,
which are from Wharton's jelly,from the human umbilical cord,
where all the stem cells comefrom, to build the baby, the
most regenerating stem cell thatexists, that message is total
rejuvenation, and based on yourcell source. So if it was from
fat stem cells or adipose orbone marrow or plants, the cargo
(04:08):
inside is different, and thesignal itself sends to your
cells are different, so you'dhave a different reaction or
response or deliverable. So notall exosomes are created equal.
Wharton's jelly has beenscientifically proven to be the
best, most rejuvenating source.And then you need to make sure
(04:30):
that your manufacturingprocesses make sure that that
exosome is still bioactive atthe end of day. So we can get
more into that, but that's kindof a little tidbit. So exosomes
have ingredients, and they havea recipe to totally restore your
skin, your hair, and 1000s ofother areas of research are
being done on the human bodyright now that are all really
(04:50):
exciting.
Dr. Kay Durairaj (04:51):
I think that's
a great explanation. And Mike,
do you have anything to add,like at the scientific level,
about the micro RNAs and I. Um,do you feel one one side
question too? I would love tocompare and contrast
polynucleotides to exosomes,which are two entirely different
animals, but they're both outthere on the market. They're
both competing for ourattention.
Michael Heke (05:14):
Um, so basically,
Aaron already, you know,
captured a perfect overview andanalysis. What it is. I think
the important parts are reallythat not all exosomes are
created equally. So virtuallyall cells secrete exosomes, but
it's therefore very important tosource your exosomes properly.
(05:34):
So for instance, tumor cells, orcancer cells also secrete
exosomes, but they have a wholedifferent task that supported
supporting tumor growth. Sothat's certainly something you
don't want to touch. So what youwant to use as a cellular origin
for your stem for your exosomes,are stem cells, because they are
considered the building blocksof life, and among those, stem
(05:56):
cells, like MSCs, mesenchymalstem cells, they are often
sourced from either bone marrowor adipose tissue, which
requires adult donors, or fromperinatal tissues, which is
placenta, umbilical cord,umbilical cord, blood and
amniotic fluid. So the adulttissues are really not optimal,
(06:17):
because even if you have ahealthy 20 year old that donates
bone marrow or adipose tissue,they have been subjected to 20
plus years of environmentalhazards, which is chemicals,
toxins, but also aging, disease,you know, bad food and it's
anything but but optimal. So youwant to use perinatal tissues
(06:39):
instead. And even among theperiodontal tissues, there are
differences among those fourthat I mentioned. The Wharton's
cherry of the umbilical cord isthe one considered the most best
suited one, because it containsa large amount of mesenchymal
stem cells, and they are evenprotected from maternal
(06:59):
contamination, such as maternalDNA, or let's say, vaccine
residues, so all of that has noability to get into the
Wharton's jelly mesenchymal stemcells. So they are the most
pristine and also the youngeststem cells that you can get your
hands on. And that's where thoseage zero characteristics come in
(07:23):
as the most important feature ofour exosomes. H zero just means,
before we are born, we have thecapacity for total regeneration
and repair, which means, in theprocess of development, the baby
in utero, if anything goeswrong, it will be fixed, can be
completely replaced byfunctional tissue, and it will
normally and therefore, it'simportant to utilize those stem
(07:47):
cells that have the ability toaffect these protection
protective mechanisms. And theseare the mesenchymal stem cells
that actually have been producedbefore the baby was born.
Interestingly, as soon as we areborn, we lose that capacity for
total regeneration and repair.We obviously have the ability to
regenerate, but even it's notperfect anymore, and then with
(08:11):
age, it further diminishes. Sowhen we harvest those MSCs from
the umbilical cord and culturethem properly, that's also very
important, then we retain theseH zero characteristics, and that
enables us to actually achieverejuvenation, because, as I
said, those are the youngeststem cells that you can have
(08:31):
when they secrete thoseexosomes. They contain all the
micro RNAs and functionalproteins and lipids, so all the
building blocks and the geneticof any cells to reboot or
reprogram itself to a youngerself, to return to a more
youthful state, and to fixitself. So if you're asking
(08:53):
about poly nucleotides or anykind of growth fact or any other
factor to compare that withexosomes, it's just not the
same. I mean, all theseindividual factors, poly
nucleotides, also vitamins, ofcourse, amino acids, all of them
are very important and relevant,and they play a role in this
(09:14):
process of regeneration andrepair. But they are just one
factor, so any given factor isjust like a palliative mean only
if you have a bioactive exosomethat fuses with a target cell,
as Aaron explained it, anddeliver all their cargo. It
enables the cell to do whateverit needs to do to actually
(09:34):
return to a fully functional andmore youthful state.
Dr. Kay Durairaj (09:37):
Got it Do we
need to be worried about getting
HLA surface antigens or when weare harvesting exosomes from any
source that's not our own or notautologous, Should we be worried
that we're getting surfaceantigens and markers of another
individual in our system? No,
Unknown (09:58):
we don't have to be
worried about. And that's why
MSCs are the primary source foralso the exosomes that we want
to use also in stem celltherapy. We also resort to MSCs
because they are immune, immuneprivileged. That means that
don't take key they don'tcontain the surface markers that
would enable your body torecognize they are foreign. And
(10:22):
there's a reason with because ifyou, if you grow a baby in your
tummy as a woman, this isconsidered, scientifically, an
elevator between the mom and thedad. So it is something foreign,
and it would be crazy if themom's body would reject it as
something foreign. So that'swhere protective mechanisms come
from, and the immune privilege.So MSC is derived from perinatal
(10:48):
tissues immune privilege, sothey cannot be recognized as
something foreign by your body,therefore they cannot lead to
any rejection. Instead, they'reactually used to treat graft
versus host disease when youhave other transplants, and
Dr. Kay Durairaj (11:04):
I think that's
so important. I think people
don't realize that enough,because when they are getting
exomes derived from otherpeople's donated fat, donated
platelets or other cellulartissues, there are foreign
antigens of that individual onthe surface, potentially of all
those exomes and
Unknown (11:22):
unlikely, but if you
get it from adult donors, it's a
little bit it's optimal, forsure, because over the course of
those 20 plus years as a as anadult donor, you might even
accrue some mutations in your inyour genetics, and they got to
be More transferred in all intoall your bodily cells, so the
(11:43):
cells, even the MSCs, are farfrom optimal for use as a
transplant or as a melogenic totreat it.
Dr. Kay Durairaj (11:53):
Now, what
motivated you guys to kind of do
this study where you looked atthe impact of lyophilizing or
taking a liquid and making itinto a dry powder with the
excess grains.
Unknown (12:06):
So the Crowley center
for Regenerative Biotherapeutics
is a venture building company.So we invest in technologies,
advanced technologies. Myfather, Michael Crowley, has
been commercializing advancedtechnologies from government
labs since 1986 so this is whatwhat we do. And so anytime we go
(12:26):
to look and invest in a newtechnology, we do significant
vetting of the industry. And youknow, we were already in the
stem cell space because that wasa byproduct of a cancer
diagnostic product that we have.So we're a Wharton's jelly
technology company. And as anauditor, I started going in and
(12:48):
understanding what were theexosomes in the cosmetic space?
Because exosomes are growingesthetically, and to open a new
brand to supply esthetics to adistributor in Dubai. And so I
spent about six months, and Iwent through every company in
the exosome esthetic space, andI saw some significant gaps.
(13:10):
First, these products are notmedical grade. They're not
having a certificate conformingwith infectious disease testing.
There's no donor history on anyof these doctors are receiving
exosomes, with no reports fromany USA CLIA labs that would
indicate that this is medicalgrade, so no sterility, testing,
endotoxin, bio burden,mycoplasma, nothing was done to
(13:32):
indicate that the stem cellsthat they got these exosomes
were medical grade, are safe.Then we also looked and we said,
what else is happening in theindustry, we saw that most of
the companies were actuallygrowing their stem cells in
what's called passages, but theywere doing it many times, 1500
times. So they're copying theirstem cells to produce more
(13:53):
exosomes, and they're makingcopies upon copies upon copies.
And what happens is, when youexpand these stem cells, they
can differentiate, they canmutate, and the axosomes they
produce are no longer good. Theychange. And so the international
Stem Cell Research Society wouldsay, Never even use stem cells
(14:14):
that have been grown more thanfour passages. So that's what we
do at regenera, our stem cellcompany, but we were refining is
that a lot of these exosomeswere coming from companies that
grow their stem cells 1500copies. Well, that doesn't look
good. So from there, we took ita little bit further and said,
what else is happening, andwhat's very different from the
(14:34):
medical space of regenerativemedicine, stem cells and
exosomes versus the esthetics,is the esthetics. All of the
products I audited as aprofessional auditor were all
they offlined. They were freezedried. Why? Why would you freeze
dry? A perfectly good ExImthere's only one reason. You
want shelf stability. You wantthis to last on the shelf of a
(14:55):
doctor's office. You want it tobe able to easily transport
without the cost of coldstorage. Much well, in a lot of
the studies, when these exosomecompanies did their own studies
that they had exosomes, a lot oftheir data is prior to the
lyophilization process, thefreeze drying process. They're
not showing you the final dataof what does that bottle look
(15:16):
like after the product's beenfreeze dried. Why this is
important is an exosome is, is,you know, a biological liquid in
a sense, right? And to make itunderstandable, I love freeze
dried strawberries. They'recrunchy, delicious. Put them on
my salad, but I can't just addsome dilutant, and suddenly
(15:37):
they're plump and red. Again,the strawberry, and that's what,
yeah, like they're plump,they're vibrant. I mean, they've
changed through that freezedrying process, right? Nutrients
have changed. They are changed.And when you lyophilize an
exome, you change them. You ripthe water out of the exosome.
The exosome is a bi lipidmembrane on the outside, and
there's lots of goodies on theinside. If you freeze dry, you
(15:59):
are removing all the liquid, andyou are breaking the membrane
open, which spills out thecargo, spills out all those
goodies. So gas, topically, youcould have some effect of growth
factors on your face. But ifthat exosome is not fully
intact, it's not complete, andit tries to be captured by the
cell, it can't signal you're notgetting an exosome effect. It's
(16:22):
broken. It's inactive. So we'veseen this, and we've done an
audit. I started doing thisaudit in 2023 and then it took
us about a year, and we hiredthe world's leading researcher
in exosomes, Dr Carla mazio fromshe's been at Boston University,
MIT. She does some, you know,collaborative work at Harvard.
(16:43):
She did her first PhD inexosomes back in 2004 when
everyone else said exosomes weretrash, and she came on full time
on our team, and we hired heressentially, like, let's look at
this whole industry, and let'slook at all the tools that you
have today to start analyzingblind studies at Harvard
University in Boston. What's inall these products? FDA is not
(17:06):
checking. No one's checking. AndI'm an auditor, and that's kind
of what I've designed, you know,to do. And I just said,
consumers deserve to know. Theydeserve to know, are they
getting a bioactive, exosomethat they're paying for, or are
they getting an inactiveproduct, yet spending 1000s of
dollars on something that is notan exosome and so that's exactly
(17:27):
what we did. We hired Dr Mazzeo.Over the last year, she's been
researching and using the Nanosite 300 technology to see, are
these particles and all of theseother bottles, are they then the
30 to 150 nanometer size, to sayyes, it's an exosome size, or is
it a different particle? Andthen after you determine that
(17:49):
yes, it's the correct size, it's30 to 150 nanometers, you have
to check that these exosomes areintact. And that's when we use
the transmission electronmicroscope at Harvard. And so a
lot of this work is in theprocess of publications been
submitted because we believeconsumers have the right to
know, and we really want doctorsto be educated about this very
(18:10):
advanced new technology and helpthem understand how they can
help their patient. But it's notby having inactive products.
Dr. Kay Durairaj (18:17):
And in looking
at this, you guys did electron
microscopy studies talk a littlebit about what that showed when
we looked at what an actualnanosome looks like when it's
been treated afterlyophilization or rehydrated.
Mike, you want to take it
Unknown (18:32):
here. That is one way
to actually check if you have a
bioactive and functionalexosome. So the thing is, as
Aaron pointed out, when youfreeze dry an exosome you
destroy the bubble, the bio,auto by lipid layer, and then
all of the all of what you haveleft, actually exosome degree.
(18:54):
And there might be some somegrowth factors left, because
proteins can be stable underfreeze drying. They might have
some effect, but it's onlypalliative, so superficial and
temporary. I always like thattoo. Moisturizer, if you have
dry skin and put a dry riser on,as long as you use the
moisturizer, it looks supple andnice, but leave it away, and
(19:16):
you're back to your dry skin.Right? An exosome can actually
fix the skin that it's no longerdry. But in order to do so, it
has to be intact, intact,functional. So you cannot
destroy this, this bubble,otherwise you lose, for
instance, all the RNAs, whichprovide the genetic instructions
for the cell to, you know, fixitself. And this that you were
(19:40):
talking about red flags, theprevalent problem in the field
is that people get hooked on theword exosome, and they don't
care where it comes from. Andthen you have, of course, you
have, like, all those bad sheep,black sheep, and do the wireless
claims like, one of the thingsis you have to be careful. You
see it all over. Place when theyclaim or advertise, they have
(20:02):
hundreds of growth factors intheir exosomes. That is simply
not true. It's veryunscientific, and it's just a
testament to their ignorance.There are roughly 50 growth
factors in existence at all, andour proteomic studies, for
instance, confirmed the presenceof 46 of them, at least the
(20:23):
remaining might be present, butunder the threshold of
detection. So all these claimsare really a problem. The free
all of the leading companies inthe sector, freeze drying, the
exosomes for the benefit of easyshipping and 10 shelf life, what
you're ending up with isexosomal debris, and not
(20:45):
exosomes. They can function asthey should and could. And
worse, I have a slide on thiswhere 5 billion exosomes feast
right result in 20 milligrams ofsome kind of powder that they
then dilute with some secretliquid. And I did the math so 5
(21:07):
billion exosomes by roughlythree microgram and when you
have 20 milligrams in there, itmeans that 99.98% of the content
is actually not even exosomaldebris. There's something else
with stabilizers, fillers, etc,and that's also a red flag to
me, because that's something youdon't want to put on your skin,
(21:28):
you know, or into your body. Youdon't want to have legalizers or
these chemicals. So, so we takegreat pride in our product that
consider HDMI in scaling, andthat's it. And if
you look at I never inject thatstuff into your body, right?
Mike, like you would never wantto inject the lay offline. No
(21:51):
way. Don't do that.
Dr. Kay Durairaj (21:56):
Yes, thanks.
Thanks for saying that outright,
because so many people out theredon't do it. I see people doing
IV exosomes, and it makes mewant to cringe, like, yeah, you
will just die of anaphylacticshock and Sep bacterial sepsis,
and God, God knows what's goingthrough your bloodstream, too.
We did this
Unknown (22:13):
electromicroscopy study
to actually really check
diligently, and we, by now, havechecked 10 competitors, like
the, you know, the more dominantones in the market, and all of
the lyophilized exosome productsout there do not contain single
exosome No,
Dr. Kay Durairaj (22:33):
all you
checked like 1817, or 18
different brands, right?
Unknown (22:38):
Yeah, and no exosomes.
I'd be furious if I was a
consumer and paid all that moneyand had nothing in my product
that was an exosome, yet labeledan exosome. And
Dr. Kay Durairaj (22:47):
then so you
guys are also testing other
things, besides just the pictureof the electron microscopy,
you're also looking atbiogenesis markers to show if
there's like, actual active RNAspresent. Mike, do you
Unknown (23:01):
want to take, kind of
the proteomics analysis, a
little bit, kind of the some ofthe work we've done recently
with a company called Creative,creative Bio Labs.
Bio Labs, yeah, that was alsofor us, because, again, when,
when you talk about claims, wealso proposed a generic list of
cargo, what an exosome typicallyconsists of, and all the things
(23:24):
that are typically present andwhat they are relevant for and
good for. But we wanted to checkour own exosomes for, you know,
actual presence of all these. Sowe did some rather elaborate, or
we're still in the process ofdoing more but elaborate
proteomic study, alsolipidomics, metallomics and RNA
(23:48):
profiling. So we were keen toidentify all the proteins that
we hope were present, and weconfirmed, or we wanted to know,
how many growth factors arepresent in our exosomes. And I
mentioned that we have, like, atleast 4650 known growth factors
present. We have over 250cytokines that we identified,
(24:11):
and all the relevant RNAs. Andthis, of course, gives ourselves
confidence. I mean, we wereconfident in our product, but we
wanted to substantiate ourconfidence, also to actually
provide this kind of informationto our customers, and make sure
(24:31):
that we go beyond wild claims tojust promote a product. I think
everybody should deservesactually the product that they
are paying for and that theydeserve. Actually, the promise
can be delivered of excellenttherapy and therapeutics, both
(24:54):
the regenerative medicine marketas well as in cosmetics and
esthetics,
Dr. Kay Durairaj (24:59):
is. There a
precise approach where we can
direct which micro RNAs aregetting encapsulated and
delivered. Since we can get a,you know, 50 different growth
factors, a bunch of cytokines,I'm assuming that we would like
to have directed therapies wherewe want specific MRA fragments,
specific growth factors. And isthere a danger in just throwing
(25:21):
the kitchen sink that you knowWharton's jelly works in the
baby, in the fetus, to go to thecells that need it specific
messaging. But do those do,those deliveries of so many
growth factors and productsoverwhelm the skin, or is it
misdirection? Is the skingetting messaging? Then belong?
That belongs to neural tissueand muscular tissue and nerve
(25:43):
tissue. That's
Unknown (25:45):
a fantastic question.
Um, so the good news is there's
no, no danger of any sort. It's,it's, at worst is like, you
know, you take too manyvitamins, then you know,
whatever the body cannot usewill just go through. And you
can, you can imagine that thesame, that's the same for
exosomes. So exosome therapy andtechnology is still early on,
(26:10):
relatively early on, I wouldn'trule it out that down the road,
you might want to manipulatethem in a certain way to
actually be more prone to dothis, or more prone to do that,
especially when it comes totreating certain diseases. I
also am acutely aware of thepharma industry being very
interested in creating hybridexosomes, where they use
(26:34):
exosomes as a carrier forcertain small molecules that
they develop certain medicationsand so on. And that all makes
sense. That is, that is a littlebit on the road, I would argue
for right now, the exosomes thatwe are providing, for instance,
they contain, like most of whatyou might be interested in, and
(26:57):
we see them as a universal tool.So we have seen them to be
successfully used treating hair,respiration conditions, skin
rejuvenation, Scar preventionand reversal. We have seen them
applied towards the treatment ofcertainly the cerebral palsy, MS
(27:22):
and many, many things moretraumatic brain injury, and it's
always the same pain. It'salways the same exosome and can
treat a variety of conditionsand what I personally feel like,
it also makes sense, becausewithin each cell of our body, we
(27:42):
have roughly 20,000 genes thatare expressed to certain levels
that make cell function in acertain way. You know, it's
extremely complex. I gave up along time ago to really get to
the bottom of it, becausebiology is just so complex that
you cannot figure it out inminute detail, therefore a more
(28:07):
holistic approach, like usingthe perfect exosome, if you
excuse me, using that term,using the perfect exosome that
provides everything anindividual Cell might need to
fix itself is for me, alreadylike a major milestone. Whether
we go ahead like, you know,personalize them in certain
(28:30):
ways, I wouldn't rule it out,but it might also not be
necessary find out there, Aaron,
Dr. Kay Durairaj (28:38):
I have a
question for you. So as an
esthetic provider, then whatshould I be asking my exosome
company for proof of in terms ofpurification, purity, sourcing,
reliability between batches. Arethere some things that you want
us to ask when we're going up tothe
Unknown (28:55):
Yeah, absolutely. Thank
you for asking. Yeah. Let's keep
it simple, safety, quality,bioactivity, that's what we want
to know. So from a safetyperspective, do you have a
certificate of conformity from aUS Lab that there was all the
infectious diseases andsterility done? We always ship
that report with every mile,whether it's our cosmetic
(29:18):
topical or it's our regenerolcompany. So safety first, last
and always make sure there's acertificate conformity for all
the infectious diseases andsterility that was done on the
stem cells. Two, make sure thestem cells are of quality, so
that they were grown in that lowpassage. They should not be
grown more than four passages,otherwise they mutate. So
(29:39):
safety, then quality is reallymaking sure that they're good,
good stem cell source. And thenthe last is, how do you ensure
that they're bioactive? Well,don't get a my offline one,
right? You want a product thatcomes with a nano site, 300 that
you have exosome particles. And.Transmission electro microscope
(30:01):
that shows your exosomes intact.This is legitimate exosome
sourcing. If you don't havesafety, quality and bioactivity,
and that's confirmed by yourdistributor or your sales person
or manufacturer, then it'sbasically buying fool's gold.
Wow.
Dr. Kay Durairaj (30:20):
And then tell
me some brands that you think do
have the safety, quality andbioactivity.
Unknown (30:27):
So I know the analysis
so far, you have to start with
who manufactures stem cells?Yes, there's only three
Wharton's jelly stem cellmanufacturers in the United
States left today, and one ofthem only sells to research
companies. The other is only inclinical trial. We're the only
(30:49):
commercial Wharton jelly medicalgrade stem cell manufacturer in
the United States. There aresome in Costa Rica, Panama.
There used to be the main WuhanInstitute in China. But at this
point, we are the onlycommercially available. So if
you ask me, what product wouldyou put on your pinpoint,
bleeding face, I would say onlyage zero. I can't recommend
(31:12):
another product fully from afull auditing perspective. Now
we have some more. The onlyproducts we tested where the
layoff lies. We wanted to getthe heavy hitters, bad hitters,
out first. Now there is acompany out of Pennsylvania.
It's that exosl bio company,right? Exosl bio, they at least
(31:35):
have a quality report. They showwhat they test for. I don't know
how many passages they do, butthey do come from a perinatal
source, they do provide acertificate of quality. But
other than that, we've doneextensive auditing, and the data
is not there for safety for 99%of the companies out there.
That's just a fact.
Dr. Kay Durairaj (31:54):
Yeah, and for
consumers listening just the
buyer beware that these productsare cosmeceuticals, which means
they're no one looks at theingredients, the safety profile
they're applied. Designed fortopical skin use only, not for
injection microneedling only,not subcutaneous injections and
IV deliveries and all of that.And that includes for hair,
(32:15):
skin, body, everything. BecauseI don't think patients realize
that too,
Unknown (32:22):
right? And I'm just
concerned where we started the
exact oversight so exact standsfor exosomes, auditing
compliance and testing membersorganization and to help
maintain the future of exosomes.Exosomes has an incredibly
bright future. The work we'reseeing in delaying of
Alzheimer's, cardiac children'scerebral palsy, every area of
(32:43):
the body and the opportunity toregenerate. This is the future
of medicine, and we cannotafford for exosm companies in
here to ride a hype and destroythe name, destroy quality. So we
can't get started on that path.I don't want to happen in the
stem cell world. 20 years agowith Bucha and COVID, be right.
We have an opportunity forincredible future, and the
(33:03):
things that Mike and I have seenwith patients is really so sci
fi, and if it wasn't real, itwould just think that you're
dreaming. But we've seen amazingresults that everyone will want
someday, and the only way we'regonna get that is if we protect
the name exosm.
Dr. Kay Durairaj (33:21):
Can you walk
us through one of your hero
products for Facial Esthetics,and what's how it works? What
kind of results we can expect?
Unknown (33:30):
Yeah, having to thanks
for asking. Before we got in the
industry, we wanted to do aclinical trial and understand
dose that's important to us, andwe didn't see major clinical
trials working on dose. So wedid 100 patient trial and
divided into three groups, postmicro needling, three microning
sessions month apart, and theygot 5 billion exosomes, 50 or
(33:53):
100 and we thought, Great, 100.We hope that wins. We're the
world's biggest manufacturer ofexomes. We can do a huge dose
reality, 5 billion is fantastic.Dose you apply it topically
after microneedling or laser,reduces redness, improves skin
texture, glow, fine lines,wrinkles, you know, all the
(34:13):
things that we're really lookingfor. I love taking our exosomes,
and every day after exfoliatingon the shower, I love to spritz
them on with an oxygen mister.It feels so good. I would always
use an oxygen mister because itcomes on cold. So if you're
doing a microneedling treatmentor laser, it feels great. And
instead of just dropping theexcess guns on that are in
Saline once and rubbing it in,you get many applications,
(34:37):
because that fine mister. I lovethat. We've got a bunch of hair
studies going on right now. Hairis a complex field. We've got
all different ages, diseasesthat are immune health
conditions. But, you know, Iwould say, start using exosomes.
Drop them on every few days,right away. If you feel like
you're having some thinninghair, it's great for scalp
conditioning. And then we're inthe front. Process of launching
(35:00):
an intimate tissue product,really, really setting
indications of, how do youimprove vaginal atrophy? I
turned 40 in just, I think,eight days. So the perimenopause
conversation is, is big for meright now. And I as an engineer,
if I start getting scared ofsomething, I really want to work
on it. So the product we'reworking on right now with them,
(35:23):
you know, postpartum andperimenopause, menopause is our
next gen and, like, what else wegot, a lot of stuff in our
parent company, clinical trialon cardiac you know, do you name
it? Post
hydrogel? Yeah, the hydrogel,yeah, and preventing scar
formation or like, really, like,yeah, Scar prevention and also
(35:46):
scar reversal to some degree,decade old scars that got
microneedled and then treatedwith exosomes, and you see major
improvement, which isinteresting, because the
reversal of scar tissue wasalways A dogma are considered
not to be possible at all. It'sjust not true, and it just goes
to show what the potential oftrue exosomes really are. I
(36:08):
mean, they can really they havethe capacity for total
regeneration and repair, and canaffect a replacement of scar
tissue with more functionaltissue. Again, that's really
remarkable. And then we alsoworking on a skincare line, but
we are doing that verycarefully, because we find that
the ingredients and the qualityand the sourcing of those
(36:31):
formulations has to match thequality standards of the
exosomes. So you don't just likeuse the random generic you know,
cream or something, and mix insome exosomes that just wouldn't
do them justice. So that'ssomething we are working on on a
more scientific level. And Ithink that when you when you ask
(36:53):
what to watch out for, what redflags to avoid, you should
really vet the provider of yourexosols. Many do. They
manufacture stem cellsthemselves, because if they
don't, they have no control overwhere those exosomes really come
from, what the quality is, etc.So that would be a red flag, and
we are deeply rooted inregenerative medicine. But I'm
(37:16):
not saying it only because ofthat fact that I would always
argue, no matter who you chooseas a provider for your exosomes,
if they are not dabbling inregenerative medicine, they are
not doing their exosomes justand they are not providing the
real deal. Because all theexosomes we actually provide,
also for the cosmetics andesthetics market, are medical
(37:37):
grade to the highest bankers,because we feel it's important
and it's just right. And asAaron pointed out, when you get
your face microneedled, it'sbasically a very big open wound,
and don't want to put anythingon there. That's not medical
grade. So in this context, eventhough Cosmetics is highly
unregulated, I think they shouldboth have the same standards of
(38:01):
quality and safety
Dr. Kay Durairaj (38:03):
in terms of
stem cells, then, Mike, are you?
Can you say a few words on that?Because that is also everywhere,
and also there's so manycharlatans promoting fake
science. I wanted to maybe bringpeople some of your key ideas on
stem cells in terms of treatmentoptions. Absolutely.
Unknown (38:20):
Yeah, there are bad
actors everywhere and similar
problem. Sometimes you getoffered stem cell treatments
with the virus claims that treatany disease. And in theory,
that's That's true. I mean, youcan actually address any kind of
conditional disease with theright kind of stem cell, and
(38:40):
then it's just about figuringout the route of application,
the right dosing, the frequency,and so on. And each person, each
patient, might have anindividual response to it. So
that is not as trivial. There isthe potential that you can treat
virtually every disease, but itis, again, very complex, and we
(39:04):
don't yet have any establishedbenchmarks, but stem cell
therapy works, and that's,again, where we come from. We
originally created the stemcells to stem cell therapy, and
then we realized basically thoseexosomes in the day when I
started stem cell therapy, wethought we inject stem cell and
(39:26):
they replace tissue. That wasnot the case. Instead, they
threw what's called Paracrinesignaling. And how will they do
that? They actually affect anybenefits through secretion of
exosomes. Exosomes are actuallycontaining everything you need,
and they're secreted from thefrom the stem cells and go to
(39:47):
the target cells. And there arethe means by which the stem
cells operate. So they areexperts in cell cell signaling
and communication. And you go,that's the next. Evolutionary
step of stem cell therapy forexosomes only.
I think it's really exciting forpeople who might be listening
(40:09):
though that are looking for stemcell treatment, is that as of
July 1, it looks like Florida'spassing the bill for stem cells
treatment for wounds, pain andorthopedic use, you have already
passed a law and, um, there's atleast one other so this is kind
of state by state rolling andyou're in Florida, put in these
(40:30):
quality manufacturing regulatorystandards, right? They, they
implemented it into thestandard. So, um, as of July, 1,
for the first time ever in thestate of Florida, Jonathan
market king, they can market, orthe feta thick and market. So
that's a big win, win for ourindustry.
Dr. Kay Durairaj (40:49):
That's
amazing. Well, you guys, in
summary, I wanted to ask you acouple quick personal questions.
If you had to focus on one ofthe hallmarks of aging, is there
one track that you think isgoing to lead us to lead us to
the cancer, telomere,mitochondria, DNA repair, Mike
or Aaron, either one.
Unknown (41:10):
Personally, I cannot
claim this to be very
scientific, because right now,it's more conviction based on
bearings and what I've seen, butI do have a hunch that exosomes,
certain ways might be, comessome fountain of you. Yeah, we
have seen actual reversal ofage. H, you know, issues like
(41:35):
hair restoration was the mostobvious one, where a person in
their mid 40s got thinning hair,we microneedled and put some
exosomes on it was our patientzero. Was the husband of our
CMO, and after just onetreatment, four weeks later, the
hair was visibly denser. But notonly that, it was also darker.
(41:56):
He had dark hair, and keepinghis age was salt and pepper, but
the patch that was treated wasoverall darker, and similarly,
our Chairman, Aaron's Father, heis in his mid 70s. Now, he had a
big bald spot on top of hishead. And we treated that micro
needling plus exosomes. Andafter two treatments, he was
(42:18):
initially a little bitunderworld because he saw some
baby hair growing in the middleof the patch, but he was hoping
for a little more. But truth betold, he also had a ball spot
for some 30 years, I think. Andthen when check those
photographs, we realized thatthe bald spot got much smaller.
It was half the size, basically.So it just goes to show that we
(42:39):
actually reverse time indeed,because that's how a bald spot
grows, right? It's thinning atfirst small ball catch, and then
it grows larger and larger. Andtreating it with exosomes, it
went the same way in reverse. Sotalking about rejuvenation,
overuse, buzz word, my sense,like we see that we can return
(43:04):
we can turn back the clock. Wecan reverse aging. So if you're
asking about the potential pixelfor you know, a fountain of you,
yes, sir, I would think thatwe'll get there if we figure out
how dosage frequencies and soon, and boot up applications, I
think we will see remarkablethings.
Dr. Kay Durairaj (43:25):
Oh, that's so
exciting. My goodness, if I
worked at age zero, I'd havethat on all over we do. And
Aaron, what's your usualbioacting regimen for yourself
at home? Do you have asupplement stack that you take,
or what do you do in this day?Super healthy. Yeah,
Unknown (43:44):
no. So I'm like Mike.
I'm a age zero, exosome girl all
the way. I've never done Botox.I do micro needling, RF, laser.
But I want to see what the worldlooks like for me without
filler. I want to be that firstperson who is only using
exosomes. I'm 39 I want to seewhat I look like at 2075 I want
(44:04):
to be the person that hasexosomes all day, every day,
missing them in we'll beinhaling them the nasal spray,
right? These are the products ofthe future, and I'm very lucky
that I get to live in the worldwhere we see that. So
Dr. Kay Durairaj (44:19):
how about
orally? Is there an oral
supplement, exosome that repairsthe GI tract yet?
Unknown (44:24):
No, that's actually
something that's being worked
on. Is timing the capsule torelease at the right point.
Yeah, so cool, yeah. Sosuppositories. I mean, we're
talking about any way you canget an exosome in. Is of
interest to our company, right?Because we like to study all of
it. We like to see what'shappening with the body. And
(44:45):
we're so lucky to haveincredible doctors and
researchers around the worldcoming to us and saying, hey, I
want to study this. And as theworld's largest producer of
exomes, we say, Absolutely,let's do it. So, Dr, k, if
there's anything
you want to study, oh my gosh, Ihave a little algorithm. I have
an email ready
(45:06):
for you. Got the product,
Dr. Kay Durairaj (45:08):
we can bring
it together. I would really like
to try it and do some reallygood studies myself. You guys
take anything for your ownhealth, like NAD Are you taking
magnesium? Are you taking,hopefully, vitamin D, etc. We've
got a
Unknown (45:23):
lot of the doctors that
do a lot of combination work
with NAD and stem cells andexosomes. So, you know, they
feel like it's a great combo.
Dr. Kay Durairaj (45:33):
Yeah,
announcing, well, I have just
really enjoyed this last hour.It's flown by. But the knowledge
that we're giving to theesthetic community and the
people out there at large is sovaluable, because there is so
much hype out there. And I thinkhaving a committee to really
look at these standards isreally critical for like you
said, we want exosomes to reachpoint they become medical
therapies that will never happenif the FDA shuts it down for
(45:57):
Bosnia and some other zones, youknow. So you guys, where can
people find you if they want tostay in touch with Aaron and
with Mike?
Unknown (46:06):
Great question. We just
got approved by forefront
dermatology, so you can find usthere at any of their offices.
We are easy to purchase directlyfrom in the United States. We've
got sales reps all over, but youcan just reach out order online.
And then we're in Dubai,Pakistan, Lebanon, Qatar. We're
(46:28):
growing all over the place.Every day, new people are
finding us and saying, Oh, atlast, we found a company that
checks all the boxes.
Dr. Kay Durairaj (46:37):
I love that.
And then you're going to stay at
the helm of the xsM exactoversight Bureau is really a
mission that I think people whowant to market their exemption
voluntarily submit their data toyou and like show that they're
so great. Hopefully, that'shopefully, that's the news.
Newest standards. Do you want togive out your Instagram handles
(46:58):
or company websites?
Unknown (47:01):
Yeah, so where you can
find us is R, E, S, I, L, I, E,
L, L, E, resilient, and we'regrowing, and we're excited to be
new players in this estheticsindustry. So thank you so much
for for having us.
What a pleasure exosomes.
Dr. Kay Durairaj (47:24):
Yeah, and Dr
Mike, thank you for your
insights. You are a world classstem cell researcher at this
hour of having your attention,so
Unknown (47:34):
we're lucky to have
Mike is a game changer for us
all. Thanks
to you and your wonderfulquestions. Yes, thank
Dr. Kay Durairaj (47:40):
you so much.
We'll do it again soon. That's
it for now. Guys, don't forgetto find me on my instagram. It's
Beauty by Dr, k, d, r, k, a, y,doing amazing things for
different faces. We know we havean injector teaching platform.
It's called Modern esthetictheory and artistry. Definitely
going to talk about these. Ijust know these and all the
standards and for our injectorsout there, don't forget to come
(48:00):
visit me, fairvin la, and that'sit for now, guys, stay
beautiful. You.