Stem Cell Therapy Research:ED

Here’s a closer look at what the science says about Stem Cells treating ED, the studies behind it, and what’s next for this promising therapy.

If you’re thinking about getting Stem Cell Therapy, our article on picking the right clinic might be useful. Or set up a conversation with our team here. They can guide you in deciding if it’s the right fit, help you choose the best clinic & region, and even assist you in securing some great discounts!

Current Trials

Regenerative Injection of Stem Cells for Erectile Dysfunction – Jumeirah America Clinic

To read more about the study yourself, here’s the link!

What is this Study?

• This is a Phase 1/2 clinical trial testing if mesenchymal stem cells (MSCs) can help men with erectile dysfunction (ED).
• The study aims to see if stem cells can improve blood flow and regenerate damaged tissue in men who don’t respond well to medications like Viagra or Cialis.

Who’s Taking Part?

• The study is enrolling men diagnosed with erectile dysfunction (exact number of participants not listed).
• Participants likely have moderate to severe ED and have not had success with standard treatments.

How Does it Work?

• Stem Cell Type: Mesenchymal Stem Cells (MSCs)
• How Are They Given? The study does not specify yet, but most stem cell ED studies inject the cells directly into the penile tissue or use IV infusion.

What’s Being Measured?

• Safety: Are there any side effects?
  Efficacy: Does sexual function improve?
  Blood Flow: Are there visible improvements in penile circulation?

The next step after this trial would be larger studies to confirm long-term effectiveness.

Stem Cell Therapy for Erectile Dysfunction – Phase 2 Trial in South Korea

 To read more about the study yourself, here’s the link!

What is this Study?

This is a Phase 2 clinical trial testing if autologous mesenchymal stem cells (MSCs) from fat tissue can help men with erectile dysfunction (ED).
The goal is to see if these stem cells can restore erectile function by improving blood flow and regenerating damaged tissue, particularly in men who haven’t responded to standard ED treatments like Viagra or Cialis.

Who’s Taking Part?

• Participants: 40 men diagnosed with erectile dysfunction
• Eligibility:
  – Must have moderate to severe ED
  – Must have failed to respond to standard ED medications
  – Age range and specific inclusion criteria not detailed in the study listing

How Does It Work?

• Adipose-Derived Mesenchymal Stem Cells (MSCs)
• The cells come from each participant’s own fat tissue (autologous).
• The stem cells are injected directly into the penile tissue via intracavernous injection.
• Unlike some stem cell studies, these cells are not grown or expanded in a lab before injection.

What’s being measured?

• Safety → Are there any side effects?
• Efficacy → Does sexual function improve?
• Blood Flow → Do blood vessel improvements lead to better erectile function?

This study is testing the short-term safety and effectiveness, and if results are promising, larger trials could follow to confirm long-term success.

Studies

1. Yiou et al. (2016, France)
   Objective: To test if bone marrow-derived stem cells (BMSC) can help with ED caused by vascular damage after prostate surgery.
   Methodology:

Study Design: Phase I/II non-randomized trial.

Participants: 18 men, ages 45–70, dealing with ED post-prostatectomy.

Stem Cell Source: Their own bone marrow.

Injection Protocol: One injection, with doses ranging from 2×10⁷ to 2×10⁹ cells.

Outcome Measurements: Erectile function (using IIEF and EHS scores) and penile blood flow (via Doppler ultrasound).

Results:

No adverse events were noted, though the benefits started fading over time, suggesting repeat treatments might be needed.

75% of participants reported better erectile function at six months.

Combined with medication, some were able to achieve successful intercourse.

2.Haahr et al. (2016, 2018, Denmark)
Objective: To see if adipose-derived stem cells (ADSC) could help severe ED cases post-prostate surgery.
Methodology:

Study Design: Phase I prospective single-arm study.

Participants: 17 men in 2016, expanded to 21 in 2018, aged 46–69.

Stem Cell Source: Fat cells (harvested via liposuction).

Injection Protocol: A single dose of 8.4×10⁶ to 37.2×10⁶ cells.

Outcome Measurements: Erectile function (IIEF-5 and EHS scores) and patient-reported ability for intercourse.

Results:

53% saw significant improvements in erectile function and erection hardness at six months.

The effects lasted up to 12 months for most.

Safety? Spotless—no serious side effects.

3. Al Demour et al. (2021, Jordan)
Objective: To explore if Wharton’s Jelly-derived stem cells (WJSC) could help diabetic men with ED.
Methodology:

Study Design: Phase I open-label study.

Participants: 22 diabetic men with stubborn ED.

Stem Cell Source: Wharton’s Jelly (a substance found in umbilical cords).

Injection Protocol: Two injections of 20×10⁶ cells, given a week apart.

Outcome Measurements: Erectile function (IIEF-15 and EHS scores) and penile blood flow (via Doppler).

Results:

Sustained improvements in function and blood flow for 12 months.

Safety profile was clean—no serious adverse events.

4. Zasieda et al. (2022, Ukraine)
Objective: To assess how mesenchymal stem cell-derived exosomes (MSC-DE) combined with low-intensity shockwave therapy (LISWT) works for ED.
Methodology:

Study Design: Prospective cohort study.

Participants: 38 men with metabolic syndrome-related ED.

Stem Cell Source: Mesenchymal stem cell-derived exosomes.

Injection Protocol: Six weekly intravenous MSC-DE injections, combined with bi-weekly LISWT sessions.

Outcome Measurements: Erectile function (via IIEF-5 scores) and vascular health (via Doppler ultrasound).

Results:

Better erectile function and blood flow at 3 months.

Safety? Perfect—no major side effects.

6. Fode et al. (2022, Denmark)
Objective: To test a same-day method for stem cell therapy using fat-derived stem cells.
Methodology:

Study Design: Prospective case series.

Participants: 10 men with organic ED.

Stem Cell Source: Adipose-derived stem cells processed using the myStem® X2 kit.

Injection Protocol: A single dose of stem cells.

Outcome Measurements: Erectile function (via IIEF-5 scores) and patient satisfaction.

Results:

Improvements lasted up to 6 months.

No adverse events.

7. Al-Derzi et al. (2024, Diabetic Men with ED)
Objective: To test if bone marrow-derived stem cells (BM-MSCs) are safe and effective for treating erectile dysfunction in diabetic men over 24 months.

Methodology:

• Study Design: Phase 2 open-label trial with a 24-month follow-up.
• Participants: 30 diabetic men with moderate-to-severe erectile dysfunction that didn’t improve with other treatments.
• Stem Cell Source: Stem cells taken from the patient’s own bone marrow.
• Injection Protocol: Two injections into the penis, spaced four weeks apart, with doses of 1–2×10⁷ stem cells each.
• Outcome Measurements: Erectile function measured by IIEF-5 and EHS scores; penile blood flow assessed by Color Duplex Doppler Ultrasound.

Results:

• Effectiveness: Erectile function and blood flow improved within 3 months. However, the benefits started to fade after 12 months and declined further by 24 months.
• Penile Blood Flow: Increased blood flow was confirmed by better Doppler readings at 3 months.
• Safety: No serious side effects occurred. Minor issues from bone marrow extraction and injections were manageable.

Conclusion:
Stem cell therapy using BM-MSCs improved erectile function in diabetic men, but repeat treatments may be needed as the effects don’t last beyond 12–24 months.

The Reality Check: Limitations of the Research

Most studies have small sample sizes, so it’s hard to generalize the results. Plus, follow-up periods are usually short, meaning we don’t fully know how long the effects last. Variability in methods—like how the stem cells are sourced and prepared—also makes it tricky to compare results across studies.

The fact that no trials haven’t gone to Phase III might also be a concern. But there could be reasons like the cost & complexity for Phase III trials are way too high and the investment just isn’t there.

2023 Review

A recent review analyzed a number of clinical trials testing stem cell therapy for erectile dysfunction. Most of these trials were Phase I/II, meaning they were focused on safety and early effectiveness rather than long-term results

What These Clinical Trials Show Us:

• Stem cell therapy shows promise, particularly for men whose ED is caused by nerve damage, poor blood flow, or diabetes.
• Direct penile injections (intracavernous) seem to work better than IV infusions, delivering stem cells directly to the affected area.
• Most studies report short-term benefits (3-12 months), but long-term effectiveness is still unclear.
• Combination therapies (stem cells + PRP or shockwave therapy) may enhance results, improving both blood flow and tissue regeneration.
• No major safety concerns were reported, but larger trials are needed to confirm safety over longer periods.

While these results are encouraging, researchers emphasize that stem cell therapy for ED is still experimental. More large-scale, long-term trials are being looked at. To read more about the review, you can check it out here.

Conclusion

To read more about the actual treatment process and how it works, we’ve put together a full article for Stem Cells treating ED here.

Positive news is studies report improved blood flow, better erection hardness, and even restored function for some men. 

While the safety profile looks solid, this treatment is still experimental.

But, if you’re prepared for the hefty price tag,  there have also been incredible stories from young men who turned to this treatment. With its solid safety track record, it could be worth considering.