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Testosterone Replacement, Low T, HCG, & Beyond
When Testosterone Is Not Enough
Gainswave For ED
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<blockquote data-quote="sokaiya" data-source="post: 182411" data-attributes="member: 31435"><p>Yes of course this is a very important point. Even for example in the USA there are many clinics claiming to have umbilical cord derived stem cells which is a complete lie. </p><p></p><p>We are currently living in a time where it is the "Wild West" of stem cell therapy. The medical community including doctors have essentially become used car salesmen deceiving people and telling them that their products contain stem cells when there are actually no stem cells present and all in the name of the Almighty dollar.</p><p></p><p>Whenever you hear "umbilical cord" "amniotic" understand that these products </p><p></p><p>DO NOT contain any stem cells.</p><p></p><p>The only form of stem cells available in the USA are derived from autologous bone marrow or adipose tissue.</p><p></p><p>There are 2 pathways for FDA donor tissues:</p><p></p><p>(1) Simple 361 tissue registration (all of orthopedic amniotic and cord blood products on market) Requires NO clinical trials or data.</p><p></p><p>(2) Complex and expensive 351 cellular drug approval.</p><p></p><p>The FDA clearly states per Sec. 1271.10 section (ii), that if your cells are alive and have metabolic activity and they're a donor tissue, then it's considered a DRUG and therefore you cannot go through the 361 tissue registration. In which case you would have to obtain the 351 cellular drug approval which none of these outfits have.</p><p></p><p>The Bait & Switch comes with the fact that these companies will reference all kinds of studies with umbilical cord stem cells, the problem is that they are referencing studies with cells that have been isolated and culture expanded (like what they are legally allowed to do in Panama, Colombia, Mexico) meaning LIVE STEM CELLS were used in these studies. However, their products are usually a frozen and centrifuged umbilical cord product that DOES NOT have any LIVE stem cells.</p><p></p><p>In addition, these companies have done no actual clinical or lab-based research that would equate with how it compares to bone marrow concentrate, it substitutes research that has nothing or little to do with its product. This is common in this field, and it works because physicians are not yet sophisticated enough to know the difference.</p></blockquote><p></p>
[QUOTE="sokaiya, post: 182411, member: 31435"] Yes of course this is a very important point. Even for example in the USA there are many clinics claiming to have umbilical cord derived stem cells which is a complete lie. We are currently living in a time where it is the "Wild West" of stem cell therapy. The medical community including doctors have essentially become used car salesmen deceiving people and telling them that their products contain stem cells when there are actually no stem cells present and all in the name of the Almighty dollar. Whenever you hear "umbilical cord" "amniotic" understand that these products DO NOT contain any stem cells. The only form of stem cells available in the USA are derived from autologous bone marrow or adipose tissue. There are 2 pathways for FDA donor tissues: (1) Simple 361 tissue registration (all of orthopedic amniotic and cord blood products on market) Requires NO clinical trials or data. (2) Complex and expensive 351 cellular drug approval. The FDA clearly states per Sec. 1271.10 section (ii), that if your cells are alive and have metabolic activity and they're a donor tissue, then it's considered a DRUG and therefore you cannot go through the 361 tissue registration. In which case you would have to obtain the 351 cellular drug approval which none of these outfits have. The Bait & Switch comes with the fact that these companies will reference all kinds of studies with umbilical cord stem cells, the problem is that they are referencing studies with cells that have been isolated and culture expanded (like what they are legally allowed to do in Panama, Colombia, Mexico) meaning LIVE STEM CELLS were used in these studies. However, their products are usually a frozen and centrifuged umbilical cord product that DOES NOT have any LIVE stem cells. In addition, these companies have done no actual clinical or lab-based research that would equate with how it compares to bone marrow concentrate, it substitutes research that has nothing or little to do with its product. This is common in this field, and it works because physicians are not yet sophisticated enough to know the difference. [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
When Testosterone Is Not Enough
Gainswave For ED
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