Gainswave For ED

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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:


  • 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.
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.
" -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.
 
Defy Medical TRT clinic doctor

Bentiger07

Member
Interesting feedback. Thank you, but I just don't know enough about stem cell therapy yet to feel comfortable with it. It needs more studies/support/people vouching for it for me to consider.
 

sokaiya

Active Member
Interesting feedback. Thank you, but I just don't know enough about stem cell therapy yet to feel comfortable with it. It needs more studies/support/people vouching for it for me to consider.

that's where you are totally incorrect. Especially on the orthopedics side there are plenty of studies out there especially for bone marrow.
 

Bentiger07

Member
Just because there are SOME studies doesn't mean the treatment is validated. So I'm not sure what part of what I said invalid, since I initially said there isn't ENOUGH studies/support/people vouching for it (personally for me to feel comfortable to consider it for my ED treatment), hence experimental at least from a US perspective. If you feel there is enough, then the question is why FDA still sees it as experimental. They list some severe adverse cases. Talking to people, the feedback I personallty received is it's been a mixed bag. Couple people said it helped, most said they wasted money, but I admit, I personally don't know someone that has been hurt so I can't verify that. I just read about it.

However, maybe I'm biased and I'm just seeing this treatment thru the eyes of US. If Mexico/Panama/Colombia has a statement about stem cell therapy for ED from a governmental agency similar to the FDA, I'm interested to read it. I'm not taking sides. I'm on the side of uncertainty while it's considered experimental to the vast majority of people. Thanks.
 
Last edited:

sokaiya

Active Member
Just because there are SOME studies doesn't mean the treatment is validated. So I'm not sure what part of what I said invalid, since I initially said there isn't ENOUGH studies/support/people vouching for it (personally for me to feel comfortable to consider it for my ED treatment), hence experimental at least from a US perspective. If you feel there is enough, then the question is why FDA still sees it as experimental. They list some severe adverse cases. Talking to people, the feedback I personallty received is it's been a mixed bag. Couple people said it helped, most said they wasted money, but I admit, I personally don't know someone that has been hurt so I can't verify that. I just read about it.

However, maybe I'm biased and I'm just seeing this treatment thru the eyes of US. If Mexico/Panama/Colombia has a statement about stem cell therapy for ED from a governmental agency similar to the FDA, I'm interested to read it. I'm not taking sides. I'm on the side of uncertainty while it's considered experimental to the vast majority of people. Thanks.

You don't understand the big picture. And the big picture is that the FDA is controlled by big pharma and that's the only reason why the USA can't use live Mesenchymal stem cells because it would take business away from big pharma.

i don't know what issues you have. Sounds like ED? You should really give stem cells a shot (no pun intended).
 

Bentiger07

Member
I don't always take the side of the FDA, but if we top that on top of personal experience from people I know, just not enough support.

If Mexico/Panama/Colombia has a statement about stem cell therapy for ED or common pains people have (back pain, etc) from a governmental agency similar to the FDA, I'm interested to read it.
 

bygeorge

New Member
Gainswave is becoming a popular treatment for ED, but is it justified? The data suggests it's a valuable treatment for a very specific group of men, and not a first treatment of choice for most others. Those men who have micro vascular occlusion by fibrosis, complications of diabetes, and others, are good candidates, where other treatments have not worked or stopped working. For most other men, it's a waste of $. Men that usually find the "usual suspects" such as T levels are good, use of PDE5 inhibitors don't help, the libido is there, but the pole is not rising, are usually older and or other issues that may lead a doc to conclude it's a micro vascular issue, are the typical candidates for that treatment.

If all the usual suspects for ED are ruled out, and that requires working with a competent doc, Gainswave may be an option worth looking into. Don't be fooled by the various places now offering for any man with ED as a viable treatment.

Cost wise it varies, and per usual, where there's competition, costs are lower, so shop around, and or work with doc to get a price you feel is affordable. As usual, for the guy who has ED who gets real benefit from a non invasive therapy, it's worth it, but "worth it" is subjective. 3-6 sessions seem the common rec, and $3K for 6 sessions appears a common price, but seems to vary widely.

Data, here's a recent meta that suggests benefits for the right men.

Low-intensity Extracorporeal Shock Wave Treatment Improves Erectile Function: A Systematic Review and
Meta-analysis
I tried it a year ago. Did 6 treatments spaced a week apart. I got no noticeable benefit. Just my personal experience.
 
There is a very popular procedure as an example if you go to Guadalajara, Mexico there is a clinic that has been in business for about 17yrs. They primarily use stem cells from the endometrium. They will scrape that, then culture/multiply them in a lab and inject them into the penis area. Many people have gotten amazing results. Again, these are live stem cells which is legal to do in a place like Mexico, Panama, or Colombia. In Mexico the clinic has all the certifications and licensed by COFEPRIS which is the US American FDA equivalent.

Last month the clinic in Guadalajara made a video regarding this procedure. Video is in Spanish. Right around the 34M mark they start covering different treatments etc before then get into the stem cell explanation.

¿Sufres de Difución Eréctil? (do you suffer from ED?)
This is done here. I've had 3 treatments over the past 6 yrs in the Charlotte, NC area. The results are not amazing, but i do believe there is better blood flow, gained some girth. I need more sensitivity. I also use TRI mix and just unable to have consistent orgasms.
 

Ribeye

Active Member
I think I have talked to 4 guys who spent over $3000 and said it was a waste of time and they had to endure sore penis for a while.
Dr Rubin recently informed me she is getting a machine. However, she did say there are copycats out there that positive data doesn’t support. It needs to be a certain type of energy to be effective in her opinion. She did not elucidate further. I have “volunteered to be her first patient…. But I don’t yet know if that will happen or exactly when is more accurate.
 

Vince

Super Moderator
Dr Rubin recently informed me she is getting a machine. However, she did say there are copycats out there that positive data doesn’t support. It needs to be a certain type of energy to be effective in her opinion. She did not elucidate further. I have “volunteered to be her first patient…. But I don’t yet know if that will happen or exactly when is more accurate.
How much is she charging you?
 

sammmy

Well-Known Member
"There are ineffective copycats out there" is the standard excuse for overhyped treatments that do not work. In a few years they change the name, some slight mods on the machine, and proclaim a "new improved" one and the scamming cycle starts all over again.

I am familiar with that scenario from the "beauty industry" skin treatments.
 
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