Stem Cells for Erectile Dysfunction

Age: 18+

Sex: Male

Trial Phase: Phase 1 & 2

Sponsor: The Methodist Hospital Research Institute

Must be taking: PDE5 inhibitors

Must not be taking: Androgen ablation, Trimix

Disqualifiers: Peyronie's disease, Hypogonadism, others

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment using stem cells to help men regain erectile function after prostate surgery for localized prostate cancer. Researchers are examining how different timing and combinations of stem cells (taken from fat tissue, known as allogeneic adipose-derived mesenchymal stem cells or HB-adMSCs) and placebo (a treatment with no active drug) can aid recovery. Men scheduled for prostate surgery with Dr. B. Miles at Houston Methodist and who have early-stage prostate cancer might be suitable candidates. Participants should be prepared to attempt intercourse at least five times a month once they regain urinary control post-surgery.

As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group. It offers participants a chance to contribute to groundbreaking advancements in prostate cancer recovery.

Will I have to stop taking my current medications?

The trial allows you to continue taking PDE5 inhibitors like sildenafil, tadalafil, vardenafil, and avanafil if you have been using them for erectile dysfunction for at least 6 months before surgery. Other medications, especially those for androgen ablation or psychiatric disorders, may not be allowed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that using stem cells from donated fat tissue for erectile dysfunction is generally safe. Research indicates that patients experienced few, short-lived side effects.

Although these stem cells are still under investigation, earlier studies have shown promise. Their testing in a phase 1/2 trial means that researchers are still carefully reviewing their safety, but there is enough early evidence to justify continued testing in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) for treating erectile dysfunction because these stem cells offer a new way to potentially restore erectile function by repairing damaged tissues and improving blood flow to the penis. Unlike standard treatments like PDE5 inhibitors (such as Viagra or Cialis) that temporarily boost blood flow, HB-adMSCs aim to address the underlying issues by regenerating tissue. The unique aspect of this treatment is its innovative mechanism of action, utilizing the body's own repair systems to achieve a more lasting solution. Additionally, the delivery method of directly injecting these stem cells into the affected area could enhance their effectiveness by ensuring they reach the precise location where they're needed most.

What evidence suggests that this trial's treatments could be effective for erectile dysfunction?

Research suggests that certain stem cells from donated fat tissue might improve erectile function. Animal studies have shown that these stem cells can enhance erectile function by repairing damaged tissues. In humans, some trials have shown promising results, with improvements in erectile function and blood flow. A review of several studies also found that these stem cells might help restore erectile function by regenerating damaged tissues. This trial will evaluate the effects of allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) in different treatment arms, including combinations with placebo, to further investigate their potential benefits. Although more research in humans is needed, the initial findings are encouraging for those considering this treatment. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

Men who have erectile dysfunction after surgery for localized prostate cancer (RALP) can join this study. It's not clear what specific exclusions are, but typically participants must be healthy enough for the trial and not have conditions or treatments that could interfere with the study.

Inclusion Criteria

Patient needs cardiac clearance by the cardiologist

Pre-op IIEF-5 > 20

Testosterone serum > 300ng/dl with normal Free Testosterone

Exclusion Criteria

Penile anatomical abnormalities (Peyronie's disease)

Hypogonadism

My AST is over 40U/L, ALT over 33U/L, glucose over 180mg/dl, or I'm on psychiatric meds.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either stem cells or placebo injections in the penis and IV at specified weeks

12 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs)
• Placebo

Trial Overview The trial is testing if stem cells from fat tissue can help restore erectile function when given during or after RALP surgery. Some men will get the real stem cells while others will receive a placebo, without knowing which one they received.

How Is the Trial Designed?

Group I: 3: allogeneic adipose-derived mesnchymal stem cells intra op and at week 12 in clinic Experimental Treatment 2 Interventions

2.00x 10⁸ HB-adMSCs locally injected into the corpora cavernosa of the penis and along the right and left neurovascular bundle of the penis in the OR at week 1 plus 2.00x 10⁸ HB-adMSCs via IV in clinic at week 12.

Group II: 2: Placebo plus allogeneic adipose-derived mesnchymal stem cells Experimental Treatment 2 Interventions

4 cc of saline solution in the corpora cavernosa of the penis and 4 cc of saline solution along the right and left neurovascular bundles of the penis in the OR at week 1 plus 2.00x 10⁸ HB-adMSCs via IV in clinic at week 12.

Group III: 1: allogeneic adipose-derived mesnchymal stem cells plus saline solution Experimental Treatment 2 Interventions

2.00x 10⁸ HB-adMSCCs locally injected into the corpora cavernosa of the penis and along the right and left neurovascular bundle of the penis in the OR at week 1 plus Placebo via IV in clinic at week 12.

Group IV: 4: placebo plus placebo Placebo Group 2 Interventions

4 cc of saline solution in the corpora cavernosa of the penis and 4 cc of saline solution along the right and left neurovascular bundles of the penis in the OR at week 1 plus saline solutin via IV in clinic at week 12.

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials

299

Recruited

82,500+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10330142/

Recent advances in stem cell therapy for erectile dysfunction SCT has been studied for ED since the 2000s, and various animal models have shown that stem cells can improve erectile function [15]. However, few human ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2214388224000262

An update on the use of stem cell therapy for erectile ... Results confirm that SCT does improve erectile function in animals with different types of SC use. In humans, evidence showed promising results, but the trials ...

3. bmcurol.biomedcentral.com bmcurol.biomedcentral.com/articles/10.1186/s12894-025-01913-5

Stem cell therapy for erectile dysfunction: promise or reality? Most showed six months improvements in erectile function parameters, particularly IIEF-related scores and PSV, supporting the therapeutic ...

4. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1519095/full

Advances in stem cell therapy for erectile dysfunction The meta-analysis's findings demonstrated that using ADSC could help restore erectile function by regenerating damaged erectile tissues (29).

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04362189

Efficacy and Safety Study of Allogeneic HB-adMSCs for the ... Hope Biosciences is conducting a research study of an investigational product called allogeneic adipose-derived mesenchymal stem cells (abbreviated as ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12395856/

Stem cell therapy for erectile dysfunction: promise or reality? The outcomes of clinical trials on stem cell therapy (SCT) on erectile dysfunction (ED) treatment are promising but there is still no conclusive ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2352396416300202

Safety and Potential Effect of a Single Intracavernous ... Preclinical studies using adipose-derived stem cells to treat ED have shown promising results. Herein, we report the results of a human phase 1 trial with ...

8. stemcellres.biomedcentral.com stemcellres.biomedcentral.com/articles/10.1186/s13287-025-04221-9

The promise of mesenchymal stromal/stem cells in erectile ... Results indicated that UC-MSC therapy improved erectile function by restoring intracavernous pressure and enhanced the smooth muscle-to-collagen ...

9. withpower.com withpower.com/trial/phase-2-erectile-dysfunction-6-2025-7beac

Stem Cells for Erectile Dysfunction · Info for Participants ... Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) and Placebo will have tolerable side effects & efficacy for patients with Erectile Dysfunction ...