sokaiya
Active Member
Reading the last few posts talk about stem cells. While it's useful to hear more about people willing to be the initial testers to use stem cell therapy to treat ED or whatever else its claimed to help, be aware there are alot of shady clinics/promoters pretending to help you thru stem cell therapy. That is adding to the hype. They'll sell you by saying it treats the root cause, that their family member was helped by it, and then when it doesn't work, they'll blame it on it being experimental. At best, you lost money. At worst, you were harmed. With that said, there is encouraging studies showing that real stem cell therapy may help ED, but it needs more research. The worst part about it is there is some data showing it can be potentially very harmful, so be careful and be safe everyone. Source:
"All medical treatments have benefits and risks. But unproven stem cell therapies can be particularly unsafe.
For instance, attendees at a 2016 FDA public workshop discussed several cases of severe adverse events. One patient became blind due to an injection of stem cells into the eye. Another patient received a spinal cord injection that caused the growth of a spinal tumor.
Other potential safety concerns for unproven treatments include:
Note: Even if stem cells are your own cells, there are still safety risks such as those noted above. In addition, if cells are manipulated after removal, there is a risk of contamination of the cells.
- Administration site reactions,
- The ability of cells to move from placement sites and change into inappropriate cell types or multiply,
- Failure of cells to work as expected, and
- The growth of tumors.
" -https://www.fda.gov/consumers/consumer-updates/fda-warns-about-stem-cell-therapies
I dont follow everything FDA says and try to look deeper into these things, but I take what they say into consideration. Much of what they say tends to hold up.
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.