Liveyon Pure Cast – Stem Cell SAFETY Explained, Liveyon Labs Compliance (E18)

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Episode 18 – Liveyon Pure Cast – Stem Cell SAFETY Explained

Dr. Gaveck: Welcome back to the Liveyon Pure Cast Podcast. I’m Dr. Gaveck, Director of Medical Education for Liveyon and today I have with me to my left, Erin Sairafe.

Erin Sairafe: Hi.

Dr. Gaveck: Chief Compliance Office for Liveyon. You are a very popular individual because everybody wants to talk to you.

Erin Sairafe: That sounds so nice.

Dr. Gaveck: Our reps know and our physicians know that you are really the one that puts a foot on the brake and says everything is going to go through these specific ways before any product comes out of your hands. So what I want to do for our listening audience today and our viewing audience today is I would like you to walk through what are the steps in order to get this umbilical cord blood from the hospital to the lab.

Erin Sairafe: There are pretty much three steps involved when it comes to determining what cord blood we’re going to use. It’s really donor screening, is one thing. Donor testing is another. And then donor eligibility determination is pretty much the last step out of those three.

Dr. Gaveck: So screening is first. What do they have to go through in the screening process?

Erin Sairafe: The collection facility will give an expecting mother a donor history questionnaire, which is a huge packet of information, and it pretty much goes over her medical history as well as getting into the specifics of where has she traveled? Has she got a tattoo recently? Things that you would see with any kind of blood donation. That’s required by FDA and AABB to make sure certain questions are asked.

Dr. Gaveck: And to be clear, these are collection companies that specialize in collecting umbilical cord-

Erin Sairafe: Absolutely.

Dr. Gaveck: -at birth?

Erin Sairafe: Yes.

Dr. Gaveck: People ask all the time, why don’t you just get cords from the hospital down the street?

Erin Sairafe: Yeah, it’s really hard to do that. You have to have an approved collection kit. So every single supply that goes into that kit is approved, we know who it comes from, the supplier itself is approved, the expiration dates are all within the allotted time. That has to have approved paperwork in it, which has to be approved by an IRB that includes the donor’s informed consent, as well as the medical health questionnaire and site assessment. And all of that documentation gets approved.

Dr. Gaveck: Right, so it’s just so much-

Erin Sairafe: It’s not as easy as just like getting one from a hospital down the street.

Dr. Gaveck: So part two is testing. Tell us about that.

Erin Sairafe: The moms are require to have their blood tested within seven days of birth. So there’s not FDA-approved test kits on cord blood, it’s for the mom’s blood. We want to know her history, her testing. So within seven days, and usually it’s done at the time of birth, the mom’s blood will be drawn, it gets sent to a CLIA-certified lab, a third party lab. They perform 12 different tests, so it’s … we call it a panel of tests that are required by FDA and AABB. It includes Hep B, Hep C, HIV, HTLV, WNV, which is West Nile Virus. Even we do the Zika virus testing now, they finally have an FDA-approved test kit to start doing that. So all of the required testing, which is 12 different ones get tested for.

Dr. Gaveck: But again, and I think this is a really important part that we’ve discussed several times, is these are things that happen at the hospital level before it ever gets to any lab in the country.

Erin Sairafe: Right, so they’ll collect mom’s blood, they ship it to the CLIA lab. That all gets done within pretty much 24 hours. We say 48 hours. Meanwhile, we receive the cord blood and then we receive the test results from the mom’s blood. And if anything comes up positive at all, other than CMV, CMV 90% of the population is positive for CMV.

Dr. Gaveck: Cytomegalovirus.

Erin Sairafe: Right, so that’s the only allowable one when it comes to coming up positive for something. If they come up positive for anything else, it’s immediately discarded.

Dr. Gaveck: So then what’s the third step?

Erin Sairafe: The third step is actually determining the donor’s eligibility status. That has to be done with what they call by a responsible person, it’s kind of weird the way they term that, but a responsible person needs to look over all of the donors, screening that whole packet that I told you about, the 14-page packet. So they look that over, then they review the test results. If anything is check marked … for instance, on that donor’s packet they check marked yes, that they’ve traveled to Africa within the past six months, those kind of things need to be reviewed and then noted. And then somebody needs to make that determination whether this donor’s eligible or ineligible, as well as looking over the testing results to see that they’ve passed everything. So that, in combination with the screening, is used to make a donor eligibility determination. So they’re either eligible or ineligible.

Dr. Gaveck: Where is that person typically located, that makes that type of decision?

Erin Sairafe: That would be myself.

Dr. Gaveck: I got you.

Erin Sairafe: Yes.

Dr. Gaveck: So that happens in house, and you follow specific criteria that’s set up to go-

Erin Sairafe: Absolutely. I follow all the FDA regulations for Part 1271. The AABB handbook, which is part of the … California State Health Department has adopted the AABB guidelines.

Dr. Gaveck: American Association of Blood Banks.

Erin Sairafe: Right. So they’re pretty much one and the same because they’re following the same regulations as AABB. So all of the regulations that are in there regarding donor eligibility, how to determine if the donor’s eligible or not, that’s what we follow. Yeah, it’s done by myself and by our senior QARA specialist as well.

Dr. Gaveck: So it goes through three steps in order to get the cord to the lab. Once it’s at the lab, then it goes through its processing of removing all the red blood cells, HLADR, all the things they don’t want, and getting down to the cells. That also is a serious amount of compliance.

Erin Sairafe: Yeah, so actually right when it comes in the door, the cord blood itself, we take a sample of it and send that out for sterility testing so that we can determine okay, did this cord blood come in dirty or was it sterile? So that gets sent out to a CLIA-certified lab for USP-71 sterility testing, as well as the end product. So 10% is what’s required of a lot to have an accurate sample size for sterility testing. So we send what we call a pre-sample, before anything gets processed, and then a post sample, which is 10% of the lot size.

Erin Sairafe: Those two things get sent out to a contracted CLIA-certified lab that does the USP-71 sterility testing, and that’s a 14-day test. And it looks at both aerobic and anaerobic bacteria, mold, fungi, spore formers. I mean, you name it-

Dr. Gaveck: Which is important that it’s 14 days because you do not see many times endotoxins from gram-negative bacteria in a shorter period of time.

Erin Sairafe: Yes, and the endotoxin testing is a separate test that they do. They follow a different standard. It’s USP-85 and 161, specifically for endotoxins. And that also … it’s required to be under 1.5 EU’s per mil, and ours is less than .05 EU’s per mil. So it’s extremely on that lower end.

Dr. Gaveck: Well, and then you look at the value of an EU, it’s a very tiny amount.

Erin Sairafe: Yes, it’s extremely tiny. And even the pharmaceutical industry, their standard is 2.0 EU’s per mil-

Dr. Gaveck: Correct.

Erin Sairafe: -so it’s pretty high in comparison to our .05.

Dr. Gaveck: So we got it from the hospital, we went through that whole three-legged process, got it to the lab. At the lab there are just hundreds of standard operating procedures that were written in order to make sure that it’s done correctly in the lab. It’s processed, it’s put in quarantine until testing comes back.

Erin Sairafe: Right. So every single lot that gets made is put in a quarantine freezer, and that’s where it will stay until everything is back. We have the maternal blood work, we have the sterility testing, we have the endotoxin testing. A QA person reviews the batch records of how many white blood cells, what’s the IG percent? They look at every single page of the batch record. They look at the cell counts, all of it. And all of that information together is used to make a determination whether it can be removed from the quarantine freezer and placed in our released freezer for distribution.

Dr. Gaveck: So it’s not just you?

Erin Sairafe: No. Oh, we have a whole team.

Dr. Gaveck: A whole team is involved in every single aspect of it, making sure that this product is clean.

Erin Sairafe: The team is needed. I mean, there’s so many components when it comes to quality control and regulatory affairs. There’s so many components of just looking at a lot’s file, all the paperwork that’s involved, how the lab makes the product, and every single lot gets reviewed. It gets reviewed and then it gets reviewed again.

Dr. Gaveck: We know sometime in the past, sometime last year, there was a company out there that was accused of possibly not doing correct sterility testing, and so there were some red flags put up and some agency said, “Well, if they didn’t do sterility testing then these patients are at risk for this communicable disease.”

Erin Sairafe: Oh yeah, no.

Dr. Gaveck: Right.

Erin Sairafe: Completely separate. So sterility testing is only looking at bacteria, mold, fungi, yeast. It’s not looking at communicable disease. That is a completely separate thing.

Dr. Gaveck: So bad thing to say, but no matter how crappy a company may be on all of their policies, if they’re receiving this cord blood from an established collection agency that was at a hospital, then the testing for the communicable disease was done and you can be very safe that it was done correctly according to the correct guidelines.

Erin Sairafe: Yes, because the collection facility is the one that’s taking the mom’s blood and sending it to the CLIA lab. The CLIA lab then does the testing, and then they give the report. It wasn’t done by that middle-

Dr. Gaveck: The labs do not do it?

Erin Sairafe: No. And it has to be done. It’s a requirement to be done by a CLIA-certified lab. That’s one of the main requirements. Any kind of diagnostic testing, where you’re giving such a significant result of whether something is infected or not has to be done by a CLIA-certified lab.

Dr. Gaveck: So it’s a complicated process.

Erin Sairafe: Yeah, there’s a lot of steps. There’s a lot of things that are involved with making a product, but then also ensuring that it’s safe and it’s a good product to put out there to the public. There’s a lot of steps involved.

Dr. Gaveck: So this has been your life for a long time?

Erin Sairafe: Yes.

Dr. Gaveck: Right?

Erin Sairafe: Yeah, probably about 15 years now.

Dr. Gaveck: Fifteen years. I was amazed when we met a couple of years ago because it was literally months, six, eight, nine months in order to write the protocols in order to have a compliance department for a potential lab.

Erin Sairafe: I don’t think people understand how much is involved when it comes to establishing a quality system, and having all of the procedures and protocols in place, written, reviewed, approved, and then also validated. All of the protocols that we write for the lab too, all of those processes need to be validated.

Dr. Gaveck: Tested and retested and retested.

Erin Sairafe: So the validations have protocols and reviews and approvals. So it’s a lot of work. That’s why we need a big team.

Dr. Gaveck: I can tell you from our standpoint, we appreciate you very much. You give us the stability. I know all the reps out there and the doctors you talk to appreciate you very much.

Erin Sairafe: Thanks.

Dr. Gaveck: Because it gives us peace to know what’s going on.

Erin Sairafe: Thank you.

Dr. Gaveck: Thank you very much. I’m sure we’re going to have you back because they’re going to request you back. But thank you for joining us on this episode of Liveyon Pure Cast and we’ll see you next time.

Erin Sairafe: Thank you so much.


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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
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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.