Liveyon Pure Cast – The Controversial 361 Designation Explained. (E06)

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Episode 6 – Liveyon Pure Cast – The Controversial 361 Designation Explained

Alan Gaveck:                          Welcome back to the Liveyon Pure Cast. I’m here with John Kosolcharoen CEO and founder of Liveyon, and Liveyon Labs. John, a few podcasts back, we talked a little bit about kind of fraud in the business, and about what’s going on.

So, one of our doctor clients called, or actually wrote, wrote a question to the podcast, asking us to clarify about the letter, the complaint that was filed against Genetech, and this whole 351, 361 type of deal.

John K:                                      Designation. The designation.

Alan Gaveck:                          Exactly.

John K:                                      In the letter that the FDA issued to Genetech, they clearly stated, that they were not manufacturing a 361 product, and infact were manufacturing a 351 product. So, today I wanted to really address what the guidelines are, and why that happened. I talked to a lot of doctors as well, and they say “Well, you’re a cord blood company. You’re using the same source and the same type of processing that Genetech did. What makes your product different than the product that they were manufacturing? And why are you taking the 361 designation versus a 351 like the FDA clearly said that they were?”

Alan Gaveck:                          Correct.

John K:                                      So I have here today, I brought this with ’cause I knew you would, you know, you’d said that you wanted to talk about this. This is the guidance for the Food and Drug Administration. This the December, 2017 corrected guidelines.

Alan Gaveck:                          Final guidelines.

John K:                                      Final guidelines. You know in part CFR 1271. This is a regulation to define or identify the criteria for regulation under 361 of the PHS, which is the Public Health and Safety Act. And basically what is says is this. It says, “In order for you not to have any pre-market requirements, you need to meet all of the following guidelines. Number one, the HCT/P is minimally manipulated.” So, you know we all know that.

Alan Gaveck:                          That’s straightforward.

John K:                                      That’s real easy. The second one, is really where Genetech dropped the ball. It’s the HCT/P is intended for homologous use. As reflected by the label, labeling, advertising or other indications of the manufacturer’s intent. So let’s talk about that one, ’cause this is where they got in big trouble.

You know, as a distributor, we’ve always marketed our product for interarticular joint injections.

Alan Gaveck:                          Correct.

John K:                                      And for homologous use, which, you know, define homologous use. Homologous use is a cell that’s being used for what it was originally intended for. Now, of course our product is a homologous mix of cell, heterogenous mix of cells. And in that mix, there’s a lot of different cell types. HSCs, MSCs, EPCs, and human umbilical vein cord cells. It’s a whole bunch of different grouping of cells. Which we feel has a better healing quality because each of those cell types put off a different type of protein.

Alan Gaveck:                          Correct.

John K:                                      We don’t really talk about all the other proteins as much. We talk about the MSC. And our product really is an MSC concentrate.

Alan Gaveck:                          Correct.

John K:                                      So, as it’s labeled, advertised, and manufactured as per the intent, we have proven that our product has MSCs.

Alan Gaveck:                          By growing culture.

John K:                                      By growing culture, so we of course have all the CD markers and there’s a lot of companies out there that say “We have markers. 70, 105-

Alan Gaveck:                          90, 73, and 105. Yeah.

John K:                                      But there’s always that little gray area of you know, what doesn’t matter. It says you need to grow them in culture. So we have been able to take our product, the peer series, we’ve been able to grow and colonize and create colony forming units in plastic. And then take those and then differentiate them down the lineage show that it’s a pure MSC.

Alan Gaveck:                          Correct.

John K:                                      Or that we have MSCs in the product. So the reason we only talk about MSCs. It’s not that our product is pure MSCs because it’s not. It is a mix of a bunch of cells, but we talk about MSCs because MSCs are responsible for growing muscle tissue, collagen, bone, and if we advertise our product as a joint injection that’s an MSC concentrate, that cell type repairs muscle, tissue, collagen, muscle ligaments, and all the-

Alan Gaveck:                          Thus if you take it full circle it is homologous.

John K:                                      Correct.So the third thing, is that a manufacturer of the HCP does not involve a combination of the cells or tissues with another article except for water, crystalloid, or sterilization, sterilizing, preserving, or storage agents. Blah, blah, blah. So, again, we’re pretty clear that we, you know-

Alan Gaveck:                          We don’t mix it with anything.

John K:                                      We don’t add anything. This is where Genetech really dropped the ball. And this is where we’re different. This is where we were safe as a distributor, and where a lot of companies are really, really, like flaunting themselves with the FDA.

Alan Gaveck:                          So this is number four?

John K:                                      This is number four. Number four says this, and I’ve read a lot of articles out there on the internet, about, you know, the big thing is the HCTP which is the Human Cell and Tissue Product, does not have a systemic effect, and is not dependent on the metabolic activity of living cells for it’s primary function. Now, How many times have you heard out there from different media releases, or blogs, or emails that get sent to physicians, that, how can you market yourselves as a 361 product, when you have live cells, and you are claiming you have live cells and number four says is not dependent on the metabolic activity of living cells for it’s primary functions?

Alan Gaveck:                          Correct

John K:                                      Here’s the answer, and here’s where Genetech got in trouble. Genetech said, “Our product can be used for systemically.”

Alan Gaveck:                          Correct.

John K:                                      [crosstalk 00:06:27] It was in the complaint they told the FDA that you can use this for IVs. When you use it for an IV what happens. If you do an IV with the product, right ventricle, left ventricle, liver, kidney, lungs, all your organs are affected.

Alan Gaveck:                          Your systemic, two or more organ systems.

John K:                                      Two or more organs are affected. So, you know, when the manufacturer says that this is for-

Alan Gaveck:                          Systemic.

John K:                                      A systemic use, then it’s considered a 351 product.

Alan Gaveck:                          Exactly.

John K:                                      Now, here’s where, the word and really gets kinda lost in translation here because it says “does not have a systemic effect on the body AND is not dependent on the metabolic activity of living cells as it’s primary function.”

Alan Gaveck:                          Correct.

John K:                                      Otherwise it’s can only be used in a first or second degree relative. So, the moral of the story here is, because we don’t manipulate the product, because we have MSCs and we’ve been able to prove that, which another thing Genetech never did. I mean, yes we sell all the markers, and yes we identified MSCs, but they never actually were able to take the product and culture it, and identify grown CFUs.

Alan Gaveck:                          So we know it’s homologous.

John K:                                      So we know it’s homologous. We know we don’t add anything to it, and the only other thing is the manufacturers intent on what the product is for.

Alan Gaveck:                          Correct.

John K:                                      Intra-Articular joint injections, and…

Alan Gaveck:                          Soft tissue.

John K:                                      Soft tissue. [crosstalk 00:07:55]

Alan Gaveck:                          Subdermal, subcutaneous.

John K:                                      So tell me this, if you inject the product into the capsule of a knee, why isn’t it systemic?

Alan Gaveck:                          Well the inside of the capsule is hydrophobic, in that it doesn’t really allow much to penetrate out. Great example of that is that joint is full synovial fluid. Stomal fluid doesn’t leak out, doesn’t run out. The inside of a joint capel is hydrophobic and the outside of the joint capsule’s actually hydrophilic. So it draws the nutrients into the joint. It does not push the nutrients out of the joint.

John K:                                      So those cells stay, they stay in the joint capsule.

Alan Gaveck:                          I mean that’s not to say 100% does, but remember the word majority of affect is in there. I think if you are putting it into the IV, intravenously, I think you can safely say, the majority of the effect is going to be systemic. However, putting it into a joint or soft tissue, even if maybe they hit a small blood vessel in the area, We still have to remember the word majority. And it’s not getting there.

John K:                                      So the bottom line is Genetech said the product could be used systemically. They didn’t colonize or prove that they had pure MSCs. Therefore, they are a 351 product because of the way they were marketing, labeling, and advertising.

Alan Gaveck:                          And their intention.

John K:                                      And what their intention was, and that’s not what ours is. We’re a 361 product. Just like all the other birthing products that are out there on the market today.

Alan Gaveck:                          So I hope we gave you some clarity. It’s not an easy subject. We’ve been through it 500 times, and you know, but it’s stuff we want to be able to do on the podcast, so keep sending in your questions. I really appreciate it, and if you need more clarity, we’ll attack this thing again.

John K:                                      Love the questions. Keep ’em coming.

Alan Gaveck:                          Cool, see you next time.

John K:                                      Bye, Bye.

 

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