Sexual Medicine Society on Unproven Regenerative Therapies for Erectile Dysfunction

Sexual Medicine Society of North America

Sexual Medicine Society of North AmericaThere are many potential causes of erectile dysfunction or ED and a host of ideas about how to treat it. Some approaches to erectile dysfunction are evidence-based and even have been rigorously proven such as the drugs Viagra and Cialis, which increase blood flow to the penis. Depending on the causes of the dysfunction, these drugs may be helpful for many people, but they are also very expensive and not panaceas.

Other approaches to erectile dysfunction are not proven at all and also pose major risks, but still are being marketed on a for-profit basis any way. Two such unproven approaches can broadly be classified as injections of supposed “stem cells” and of platelet-rich plasma (PRP). The stem cell injections are usually of fat stem cells in the form of the non-FDA approved drug product called stromal vascular fraction (SVF).

I’ve written before about how some clinics are claiming that stem cell-related approaches can effectively treat ED, while others are marketing stem cells to increase penis size or somehow make vaginas “younger” or somehow otherwise enhance sexual function. But to my knowledge there are no strong clinical studies (using placebos and blinding) supporting these approaches. You can imagine that injections of unproven biologic materials into penises or vaginas pose risks.

An organization called the Sexual Medicine Society of North America (SMSNA) recently issued a position statement on the use of stem cells, PRP, and shockwave therapy for ED. While I don’t agree with everything in this SMSNA statement, there are some helpful recommendations in it. The key take-home message is this concluding portion:

“Thus, given the current lack of regulatory agency approval for any restorative (regenerative) therapies for the treatment of ED and until such time as approval is granted, SMSNA believes that the use of shock waves or stem cells or platelet rich plasma is experimental and should be conducted under research protocols in compliance with Institutional Review Board approval. Patients considering such therapies should be fully informed and consented regarding the potential benefits and risks. Finally, the SMSNA advocates that patients involved in these clinical trials should not incur more than basic research costs for their participation.”

In other words, it’s not okay to sell regenerative therapies for ED for a profit. I’d go substantially farther and say that in addition these “treatments” should not be used outside of a standard IND-based clinical trial process. The same goes for other regenerative sexual “therapies” that are not based on rigorous science.

3 Comments

  1. You should have Dr. Runels give you a guest post about this topic as he is the doctor who literally invented the technique. It’s called the P-Shot and the O-shot. It’s probably fair to have him give his own rebuttal vs. you characterizing any provider who has taken his courses as a charlatan or runs a “dubious” medical clinic. He should be the person to defend himself.

    Just FYI, you can’t even perform/promote the procedure without his training (you can’t call it O-Shot or P-shot). I am fairly certain he has published research on the topic.

    One more thing.. Insurances are starting to cover regenerative medicine i.e. stem cell injections. Aetna(don’t have exact plan but do have proof, I do have the letter) recently sent out letter stating that they are covering the procedures now.

  2. John, I simply can not find the Aetna policy change you speak of. Please post the link to your redacted Aetna policy showing they cover PRP or any stem cell source for an orthopedic or sexual medicine clinical indication and the letter will also show the ICD-10 and the CPT codes that go along with this policy change.
    As of this right now I have searched my provider portal with Aetna as well as their most recent policy statements, I cannot find any such Aetna policy change in the United States.
    I would love the info so that I can update my regulatory talk that I give to other doctors and surgeons. Thanks for posting and helping me out!

    Any medical doctor so inclined can inject the penis or vagina with PRP. It is an injection and not complex or technically challenging. Charles Runels can trademark the name or patent a device but he can’t stop every other doctor from injecting part of the body.

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