Stem Cells Show Early Promise As an Erectile Dysfunction Cure

Could a cure for erectile dysfunction be on the horizon?

Currently, we have many effective treatments for erectile dysfunction (ED), including medications (sildenafil, tadalafil, vardenafil), penile injection therapy, wearable constriction devices such as Eddie by Giddy^®, and penile implants, to name a few. But they are just that—treatments.

However, some medical professionals tout stem cell therapy as the potential cure for ED that so many men desire.

Not so fast, says the FDA.

Few studies of stem cell therapy for ED have been conducted on humans, and the treatment hasn't been proven safe and effective, so it has yet to be approved by the Food and Drug Administration.

When ED patients ask urologist Seth Cohen, M.D., if they should try stem cell therapy, he tells them, "I don't have enough data to tell you not to do it, and I don't have enough data to tell you to do it. All I can tell you is to find someone reputable enough who is a urologist, because you'll have people out there who are not urologists injecting penises."

If stem cell therapy proves to be safe and effective, it would be a great addition to doctors' armamentarium of ED treatments.

Cohen, an assistant professor of urology and director of sexual medicine at NYU Langone Health, remains skeptical of stem cell therapy for ED at present, but he's excited about the prospect.

"I think if it works, it would be the first cure for erectile problems and erectile dysfunction," he said.

Petar Bajic, M.D., a urologist at Cleveland Clinic's Center for Men's Health at the Glickman Urological & Kidney Institute, said if stem cell therapy proves to be safe and effective, it would be a great addition to doctors' armamentarium of ED treatments.

"I just think at the current stage, we do not have enough robust evidence for me to include that in the treatment options that I discuss with my patients," he said.

Note he said, "at the current stage."

Stem cells are cells in the body that have the potential to develop into many different types of specialized cells, such as muscle cells, blood cells and brain cells. Stem cell therapy for erectile dysfunction typically involves injecting a man's stem cells into his penis. These stem cells are usually derived from adipose, or fat, tissue. This therapy is a restorative approach, meaning its goal is to reverse the underlying changes that led to the man's erectile difficulties.

Cohen explained that University of California, San Francisco urologist and researcher Tom Lue, M.D., was ahead of the curve a couple of decades ago when he began injecting different types of stem cells into lab rats. Lue was trying to see if he could help rejuvenate parts of the penis that were damaged during different types of surgery, particularly prostate surgery. When the prostate gland is surgically removed, that typically damages the blood vessels that go to the penis.

Using different types of stem cells, Lue wanted to figure out a way to regrow either nerve tissue along the top of the penis or nerves that go to the penis, or help stimulate blood flow into the penis, Cohen said. He added that adipose-derived stem cells are the easiest to obtain and least likely to have adverse effects on someone.

This therapy is a restorative approach, meaning its goal is to reverse the underlying changes that led to the man's erectile difficulties.

"You basically spin down those fat cells, and then there are different types of enzymes and solvents and machines that can actually separate the fat cell from the stem cell," he said. "With that little portion of fluid, we reinject it into the penis with the hope—and the theory—that you'll rejuvenate either blood flow going into the penis or stimulate regeneration of damaged nerve tissue."

In data from testing on lab rats, Lue did show improvement in blood flow and erectile function.

"The question is how does that translate into human data?" Cohen said. "The quick and easy answer is that we don't have any large samples of human data."

Stem cell therapy for ED is a "promising option to treat ED, although published data exist for less than 100 patients," stated a 2020 review of literature published in the International Journal of Impotence Research. The authors noted that large placebo-controlled trials with a longer follow-up are necessary to confirm the long-term safety and effectiveness of the therapy.

In a much-publicized study conducted by a research group in Denmark, stem cells were injected into the penises of 21 men who had undergone radical prostatectomy, or removal of the prostate. None of them reported significant side effects, and within six months of the treatment, 8 of the 21 men reported they had recovered sufficient erectile function to achieve penetrative sex.

However, there is still a dearth of high-quality research conducted on humans to prove stem cell therapy is safe and effective. The consensus among both the Sexual Medicine Society of North America and the International Society of Sexual Medicine is the therapy should be "investigational" at this stage. This means stem cell therapy should only be administered as part of a research study.

Cohen said much of the current research is made up of anecdotal studies of 20 or fewer patients with different types of stem cells—placental or bone marrow or adipose—that have yielded mixed results. What's needed are several randomized, double-blind, placebo-controlled studies.

Bajic agrees.

"[Such studies] are the highest quality kind of research that you can have to prove whether or not a treatment is both safe and effective," he said. "It's a gradual process and can take a very long time. I think over the course of time, things will kind of declare themselves as to whether or not [stem cell therapy] has a role in our treatment algorithm."

Cohen doesn't think we're close to knowing whether stem cell treatments work, but we could be 10 years away: "I would hope, or we get the data that says it doesn't work, so we move on to the next thing."

Unfortunately, there are many direct-to-consumer ads for clinics around the country offering stem cell treatments for ED at hefty prices.

"For people considering it, I would suggest not proceeding with those, at least in the current time, until we have more information available about their safety and efficacy," Bajic said. "Buyer beware. I think you have to always exercise caution and always try to also pay attention to whether it seems like whoever is advertising this or administering it may also be making a profit on the side from that treatment."

Cohen added a warning to patients about the risks of having stem cell therapy administered by someone who is not a urologist.

"The penis is a sacred organ—at least it is to me," he said. "You can't replace it if it gets infected or falls off or breaks. Having a random person put large-bore needles into your penis who may or may not be a board-certified urologist, I think is risky."

Giddy urologist Dr. Edwin Morales explains the types of ED causes in the ED Guide video series. Click here to watch the video. Remember, there are a number of treatment options for ED, including wearable devices, such as Eddie by Giddy^®, or vacuum pumps, pills, injections, surgery and others. Talk to your doctor about what's right for you.