Liveyon Pure Cast – Busting Stem Cell Myths (E09)

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Episode 9 – Liveyon Pure Cast – Busting Stem Cell Myths

Dr. Alan Gaveck: Welcome back to the Liveyon Pure Cast podcast, I’m Dr. Alan Gaveck, Director of
Medical Education and Clinical Application for Liveyon. And, of course, across from
me, is John Kosolcharoen:, CEO and Founder of Liveyon. How you doing today?

John Kosolcharoen: Awesome. Thank you man.

Dr. Alan Gaveck: So I was thinking we could have some fun on the podcast today.

John Kosolcharoen: Yeah?

Dr. Alan Gaveck: And we’ll call this Mythbusters.

John Kosolcharoen: Ooh, like that one.

Dr. Alan Gaveck: There’s a lot of, not necessarily myth. I think the reasonable questions that people
ask, so that’s what we need to-

John Kosolcharoen: I hear some of them. I’ve heard cancer causes tumors. Can you get cancer? What happens
to the DNA? There’s a lot of different things-

Dr. Alan Gaveck: HIV, hepatitis, blah-blah-blah, yada-yada-yada.

John Kosolcharoen: Transfer of communicable diseases.

Dr. Alan Gaveck: Right, right. So we really need to start at the top, so that people understand the
real truth about this and what it is. So basically, any mother who is having typically
a pre-planned cesarean section, is asked if they would like to keep their cord for
themselves. Few do, probably less than 10%.

John Kosolcharoen: Actually, anybody that’s having birth, but including cesarean.

Dr. Alan Gaveck: Yeah, right.

John Kosolcharoen: I mean, we try to get ceasarean sections all the time, but we do take some regular
births. You know, the truth is, the hospital is required to test the mother’s blood
correct within seven days of birth, but they typically do it at the time of birth.
They test the mother’s blood. They draw it and they send it out to an independent
CLIA-certified lab, for a full pathology report.

Dr. Alan Gaveck: Right, and what they’re looking for, communicable disease, right?

John Kosolcharoen: Yeah, it’s actually a very specific test that they run on the mother’s blood, to look
for HIV, hepatitis, syphilis.

Dr. Alan Gaveck: But even before she’s accepted, she has to fill out the full medical history, social
history, travel history-

John Kosolcharoen: Mm-hmm (affirmative). Yeah, it’s crazy.

Dr. Alan Gaveck: Blah-blah-blah. I mean, it’s big. It’s in accordance with the American Association of
Tissue Banks.

John Kosolcharoen: Yeah. I think we had talked about this in one of the, we touched on it a little bit,
in one of the other podcasts, that only about 10% of the cords that are scheduled for
donation actually make it, because the requirements are so strong. I mean, if you’ve
had a tattoo in the past year, you’re not eligible to donate a cord blood. That really
is just a primary, cautionary measure, to ensure that there’s no transfer, or
contamination, or disease with the mother.

Dr. Alan Gaveck: Those reports are sent to the compliance department at Liveyon, correct?

John Kosolcharoen: Yeah. Nothing comes out of our quarantine lab, until we have received the pathology
report on the mother’s blood from the hospital. So the hospital, the baby’s born, they
take the mother’s blood, they send it off for testing and there’s a whole list of
tests run. You know, listed by the American Association of Tissue Banks. Once that
pathology report is done, we get a copy of that and put that on file. So …

Dr. Alan Gaveck: So, we had communicable disease. The other biggie would be bacteria, right?

John Kosolcharoen: Yeah. Bacteria, I mean, endotoxins, gram-positive, gram-negative, and that could be
anything on the cord, around the cord, in the blood, or anything during processing,
and even the finishing and crowd preserving of the product. So we select 10% of every
single lot that’s made and send that off to an independent CLIA-certified lab for a
special test. That’s the USP 71 sterility test. That’s testing for gram-positive,
gram-negative bacteria.

Dr. Alan Gaveck: Correct. The endotoxin test is specifically for gram-negative bacteria, because you
don’t see it.

John Kosolcharoen: Mm-hmm (affirmative). Right.

Dr. Alan Gaveck: What’s also interesting … And Margaret, Dr. Margaret Koontz, the Chief Scientific
Officer at Liveyon, has went over and implemented a protocol that they do a CBC with
the diff count when the blood originally gets there. A diff count will give you an
idea if there’s a problem with the blood. If you see a left shift white blood cells,
with a whole bunch of immature white blood cells, you have the probability of an
infection, right?

John Kosolcharoen: Yes. That’s correct.

Dr. Alan Gaveck: Midway through the processing of the cells, they do it again. At the end, before they
cryopreserve, they do it a third time.

John Kosolcharoen: That’s actually one of our protocols. That’s kind of … I wouldn’t say proprietary,
because you shouldn’t do it, but it’s nothing that’s required, it’s just an extra step
that we look at. If something doesn’t show up on the pathology report, or something
doesn’t show up on the endotoxin report, that test is going to determine, just based
on the shift of the difference … That sounds kind of funny, right? The shift of the-

Dr. Alan Gaveck: Yeah.

John Kosolcharoen: That there’s nothing wrong with the blood coming in from the mother in the first
place.

Dr. Alan Gaveck: Well, we saw one last week. We saw one last week, that had the left shift of white
blood cells. There was three times the …

John Kosolcharoen: 300% more.

Dr. Alan Gaveck: Yes, of a left shift of the white blood cells, and they just … It’s not even a
question, they discarded it. You know?

John Kosolcharoen: Yeah, yeah.

Dr. Alan Gaveck: It’s a possibility, it could be inflammatory cells. We’re not going to take the
chance.

John Kosolcharoen: We’re not going to process it.

Dr. Alan Gaveck: Right. We don’t need to do it. So there, that’s a good one. How about cancer?

John Kosolcharoen: Yeah, I mean people say, “Oh, I heard that stem cells can cause cancer.” Or, “Cause
cancerous cells.”

Dr. Alan Gaveck: Right, so stem cells are actually used to treat cancer in many, many cases. Which, if
you’ve read the studies, at the end of the studies, they will typically say, “Using
these stem cells, we saw a reduction in the size of the tumor and no new expression of
cancer.” So, it’s non-tumorigenic, non-oncogenic. Thus, we feel comfortable saying
that stem cells do not create cancer.

John Kosolcharoen: Well, besides, it isn’t that stem cells are differentiating in your body anyways.

Dr. Alan Gaveck: Correct.

John Kosolcharoen: They’re not. They’re really just, through paracrine signaling, homing to damaged
areas, damaged cells.

Dr. Alan Gaveck: Well, that also answers the DNA question.

John Kosolcharoen: Well, that’s another myth.

Dr. Alan Gaveck: Right, right. How about if they have a DNA problem, are you going to transfer DNA to
me? No, because these cells do not have in graft into your body.

John Kosolcharoen: They don’t in graft. The DNA cannot penetrate the nucleus of your cell, so the DNA
sloughs off, and it’s passed on, like anything else.

Dr. Alan Gaveck: Right. It’s an allogeneic cell.

John Kosolcharoen: Correct.

Dr. Alan Gaveck: It’s not an autologous cell. Does it create tumors? Which is kind of a different
question here, because if you read the … What is it? The Wall Street Journal
article, a couple years ago, the man who went to China, Russia and Brazil and had
injections in his spine of animal-

John Kosolcharoen: Animal. Yeah, a xenograft.

Dr. Alan Gaveck: Yeah, a xenograft. Animal embryonic stem cells and he got a teratoma.

John Kosolcharoen: Right.

Dr. Alan Gaveck: Well, think of it, it’s an animal cell, so it’s a different species.

John Kosolcharoen: Your body’s attacking it.

Dr. Alan Gaveck: It’s an embryonic cell, so it is still in the process of creating. It wants to become
heart, liver, lung, teeth, hair, blah-blah-blah. Yeah. Well, I mean, if you know the
definition of a teratoma, that’s what it is.

John Kosolcharoen: Right.

Dr. Alan Gaveck: So, yes, they do see teratoma formation in xenogenic grafts, which are typically
embryonic sheep cells.

John Kosolcharoen: Right, yeah.

Dr. Alan Gaveck: There’s not reported cases of it in umbilical cord blood stem cells.

John Kosolcharoen: No. You know, I think, a lot of that is the media. Just kind of like trying to, you
know, horror cells, contamination cells …

Dr. Alan Gaveck: Correct.

John Kosolcharoen: Products that are unapproved, or untreated, that stuff, cells. The thousands of cases
where somebody got healed and feel better, that’s not going to sell a newspaper.

Dr. Alan Gaveck: Well, hundreds of thousands.

John Kosolcharoen: Hundred … Millions, maybe. Probably millions.

Dr. Alan Gaveck: Yeah, so I mean, I think that’s the basis for our myths. Am I missing anything that’s
really big?

John Kosolcharoen: Those are some good ones.

Dr. Alan Gaveck: Obviously, these are not aborted fetuses.

John Kosolcharoen: No.

Dr. Alan Gaveck: These are complete full-term babies, minimum of 36 weeks. They’re usually 36 to 40
weeks.

John Kosolcharoen: I mean, a lot of people don’t know the difference between stem cells derived from the
umbilical cord blood or the umbilical cord.

Dr. Alan Gaveck: The tissue.

John Kosolcharoen: The tissue.

Dr. Alan Gaveck: Yeah, and you know-

John Kosolcharoen: That’s two totally different, not totally two different cell types, but two different
sources used for different things.

Dr. Alan Gaveck: Right, cord blood is cellular in nature and cord tissue is structural. Cord tissue can
be similar to fat.

John Kosolcharoen: Mm-hmm (affirmative).

Dr. Alan Gaveck: Because, your stem cells in your fat all come from a structural tissue. Interesting
thing about the cord tissue versus the cord blood, and I know you know because we talk
to the PhDs all the time, we get this … I mean, basically, you have a readily
available supply of very healthy cells in your cord blood. The cord tissue also have
it there, but the problem is, it’s in that fibrous structural tissue.

John Kosolcharoen: Yeah, you have to-

Dr. Alan Gaveck: How do you get it out?

John Kosolcharoen: Enzymatically digest the tissue, or grind it up, or do you do something? Then, you end
up with a ton of debris.

Dr. Alan Gaveck: Right and you don’t have very many cells.

John Kosolcharoen: Mm-hmm (affirmative).

Dr. Alan Gaveck: I mean, you know as well as I do, that at the lab, last week, they tested some cord
tissue.

John Kosolcharoen: They did. They tested three products, from a particular company that had three
different product types.

Dr. Alan Gaveck: Correct. I was reading the review on the court tissue. Touts to have 1.1 million
cells.

John Kosolcharoen: Yeah, 30,000.

Dr. Alan Gaveck: It had a little over 30,000 cells-

John Kosolcharoen: 30,000 cells.

Dr. Alan Gaveck: And zero were alive.

John Kosolcharoen: Zero were alive. Not just that, but this is what Margaret said. She said, “At first, I
looked at the product on the slide and it looked … I thought the slide was dirty.
It’s like, I cleaned the slide off, and I realized, no, it was just a bunch of the
debris field on the slide, but that was the product.”

Dr. Alan Gaveck: That’s great. So, I think we covered the myths. Now, there are no more questions for
stem cell science. We’re good.

John Kosolcharoen: No, we’re good.

Dr. Alan Gaveck: Yeah, okay.

John Kosolcharoen: How about we just solve world peace tonight?

Dr. Alan Gaveck: I love it. Whirled peas or world peace?

John Kosolcharoen: Both. Let’s solve both.

Dr. Alan Gaveck: All right, perfect. Hey thanks, everybody, for joining. We’ll do it again.

John Kosolcharoen: Thanks.

Dr. Alan Gaveck: All right man, bye.

 

 

Medical Professional Viewing Only (Disclaimer)</font color>


This site was intended for education purposes only and strictly for use by medical professionals. The FDA recently re-confirmed, there is only one registered stem cell product, and while there is enormous promise in stem cell therapies, and thousands of ongoing experimental applications trying to establish efficacy, these are not at the point where they would meet the scientific standard.
The FDA has stated:
Stem cells, like other medical products that are intended to treat, cure or prevent disease, generally require FDA approval before they can be marketed. FDA has not approved any stem cell-based products for use, other than cord blood-derived hematopoietic progenitor cells (blood forming stem cells) for certain indications.
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194655.htm
This site is not intended for consumers.
If you are considering stem cell treatment in the U.S., ask your physician if the necessary FDA approval has been obtained or if you will be part of an FDA-regulated clinical study. This also applies if the stem cells are your own. Even if the cells are yours, there are safety risks, including risks introduced when the cells are manipulated after removal.
“There is a potential safety risk when you put cells in an area where they are not performing the same biological function as they were when in their original location in the body.” Cells in a different environment may multiply, form tumors, or may leave the site you put them in and migrate somewhere else.
If you are considering having stem cell treatment in another country, learn all you can about regulations covering the products in that country. Exercise caution before undergoing treatment with a stem cell-based product in a country that—unlike the U.S.—may not require clinical studies designed to demonstrate that the product is safe and effective. FDA does not regulate stem cell treatments used solely in countries other than the United States and typically has little information about foreign establishments or their stem cell products.
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm286155.htm
Stem cell therapies have enormous promise, but the science in each use is still in the developmental stage. Professional judgment and expertise is needed in using stem cells for any therapeutic use, and we urge anyone embarking on the use of stem cell therapies to consult the national health data bases to evaluate current information from clinical trials and the FDA websites on human tissue should also be consulted to get its current evaluation of any therapy.