Stem Cell Research: ED

Stem cell research for ED is gaining traction, it’s a huge challenge for men globally.

We’ve broken down each study in detail, but we know it’s a lot to digest. 

At the start of the article, we’ve provided an initial summary of what all the research is telling us. 

If you want to look at any study in particular, use the Content Table on the left to go to a particular study.

We hope this is helpful!

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Current Trials looking at Stem Cells for ED

Pharmicell Phase II Trial: Cellgram-ED Stem Cell Trial for ED: South Korea: Ongoing

Who is Running this Trial?

• This clinical trial is sponsored by Pharmicell and is being conducted in South Korea. The full trial details are published on their clinical trials page.

What are They Looking At?

• The trial is designed to evaluate the efficacy and safety of a new stem cell therapy called Cellgram-ED for men with erectile dysfunction (ED) following radical prostatectomy. 
• This is a Phase II, single-blind, multi-center, and randomized trial, meaning that participants will be assigned by chance to either the treatment or a placebo group and only the researchers will know who is getting which.
• The researchers are measuring several things to determine the treatment’s success:
  1. Primary Outcome: The main goal is to measure the change in the Erectile Function  score on the International Erectile Function Questionnaire (IIEF) at the 6-month mark compared to the beginning of the study.
  2. Secondary Outcomes: They’ll also measure changes in the IIEF score at 1, 3, 9, and 12 months, as well as patient-reported success rates for sexual activity and a global assessment of improvement.
     • The trial will also use Penile Doppler Sonography (PDS) at 6 and 12 months to measure changes in blood flow, which helps determine if the treatment is having a physical effect.

Who are the Participants?

• The trial plans to enroll an estimated 54 male participants between the ages of 19 and 79.
• To be eligible, they must have ED that has lasted for at least six months following a radical prostatectomy.
• They must have a partner and be willing to engage in sexual activity at least four times a month. Additionally, they must have tried and failed to achieve a satisfactory erection with the maximum dose of oral ED medications (PDE5 inhibitors).
• Participants must not have certain health conditions like severe heart disease, a history of cancer within the last five years, or specific infections.

What Kind of Stem Cells are They Using?

• The therapy uses autologous bone marrow-derived mesenchymal stem cells (MSCs). Stem Cells taken from their hip bone in other words.
• The specific name of the product is Cellgram-ED. 

How Will the Treatment Be Given?

• Participants in the treatment group will receive a single intracavernous injection of the Cellgram-ED product. 
• Intracavernous means the cells are injected directly into the spongy tissue of the penis. 
• The placebo group will receive a single injection of a placebo. Both groups are permitted to take their oral ED medication (PDE5 inhibitors) during the study.

When Will the Results Be Ready?

• The study began on October 19, 2020. The estimated final data collection for the primary outcome is December 31, 2025, with the full study estimated to be completed by January 31, 2026.
• As this is an ongoing trial, there are no published results available at this time.

Previous Trials looking at Stem Cells for ED

2024 Phase II Bone Marrow Derived Stem Cell Trial for ED: Jordan & Saudi Arabia

This research is a follow-up to an earlier study, looking at the safety and effectiveness of a stem cell therapy for men with diabetic erectile dysfunction (DM-ED). It was published on BioMed Central.

This was an open-label Phase II clinical trial, meaning both the doctors and the patients knew who was receiving the treatment. 

The study tracked a small group of patients for two years. The research was a collaboration between scientists and doctors from the University of Jordan and Dr. Sulaiman Al Habib Medical Group in Saudi Arabia.

Participants:

• The study enrolled a total of 24 patients, but only 8 men were included in the final analysis.
• Their average age was 55 years old, and they had been living with diabetes for an average of almost 11 years. They were also all unable to achieve a satisfactory erection with oral medications.

Procedure:

• Cell Type & Source: The study used autologous bone marrow-derived mesenchymal stem cells (BM-MSCs). This means the cells were collected from the patient’s own bone marrow.
• Method: Each patient received two intracavernous injections of the stem cells, administered 30 days apart. The dose for each injection was 20 million cells.
• Passage Number: The researchers grew the stem cells in a lab, using cells from passage number 3 for the injections.
• Cell Quality: The cells were grown in a lab and went through rigorous testing to confirm they were the correct type of stem cells. They were also checked for contamination to ensure safety.

Key Results

• Safety:
  • The treatment was found to be very safe. No serious side effects were reported.
  • Patients experienced minor, temporary pain at the bone marrow collection site and mild penile pain, redness, or bruising at the injection site.
  • These side effects were easily managed and resolved quickly.
• Effectiveness:
  • Erectile Function Scores: Patients’ erectile function was measured using two questionnaires, the IIEF-5 and the EHS (Erection Hardness Score).
    • There was a significant improvement in both scores that was sustained for up to 12 months. The peak improvement was seen at the 6-month mark.
    • At 24 months, the scores had dropped back to their starting levels.
  • Blood Flow: A key finding was the significant increase in Peak Systolic Velocity (PSV), a measure of blood flow, at 3 months after the injections. This indicates that the treatment improved the circulation needed for an erection.
    

How the Cells Worked

• The researchers believe the stem cells helped primarily by:
  1. Improving blood flow: The increase in PSV suggests that the stem cells had an angiogenic effect. They helped to promote the formation of new blood vessels, which is critical for erectile function.
  2. Sending out healing signals: The study suggests the main benefits came from the cells’ ability to send out signals to help the body’s natural healing process. This is known as a paracrine effect. They release factors that protect cells and prevent scar tissue from forming, rather than the cells differentiating and becoming new tissue.

What We Don’t Know (Limitations)

• No Control Group: This was an unblinded, open-label trial with no placebo or control group. This makes it impossible to definitively say that the improvements were caused directly by the stem cells and not other factors, like a placebo effect.
• Small Patient Group: With only 8 patients completing the study, the results are considered preliminary and need to be confirmed with a much larger group of people.
• Limited Imaging: The study did not include long-term imaging studies to evaluate the safety of the treatment.

Conclusion

This study provides strong support for the safety and feasibility of using two stem cell injections to treat erectile dysfunction in men with diabetes.

While the treatment provided a significant and tangible improvement in erectile function, the benefits were temporary, lasting for about a year.

The researchers concluded that repeated injections might be necessary to maintain the treatment effects. They also stressed the need for a larger, placebo-controlled trial to confirm their findings.

2020 Pilot Study: Combined Adipose Derived Stem Cells & Platelet Lysate Plasma for ED: Greece & UAE

This research is a pilot clinical trial that investigated the safety and effectiveness of a combined therapy for erectile dysfunction using adipose derived mesenchymal stem cells and a substance from blood.

The study was open-label, meaning both the patients and the doctors knew what treatment was being given.

The paper reports the 6-month results from a small group of patients. The research was a collaboration between medical institutions in Greece and the UAE.

Participants:

• The study included five male patients with organic erectile dysfunction.
• They had various underlying health issues, including diabetes, hypertension and Peyronie’s disease
  

Procedure:

• Cell Type & Source: The study used autologous adipose-derived stem cells (ADSCs), which were collected from the patients’ own abdominal fat through liposuction
• Combined Treatment: The stem cells were combined with Platelet Lysate Plasma (PLP), which was prepared from the patient’s own blood. The researchers believe this combination might mimic the beneficial factors found in unprocessed tissue.
• Method: The combined solution was infused into the penis. Each patient received a single injection.
• Dosage: The number of stem cells injected varied for each patient, ranging from 9.5 million to 53.2 million. The lower dose for Patient 1 was due to a different collection method used initially.
• Passage Number: The stem cells were cultured in a lab until they reached passage number 3 before being used

Key Results:

• Safety
  • The treatment was deemed safe, with no serious side effects reported up to the 6-month follow-up.
  • The only adverse event was a minor pain in the penis during the injection that resolved on its own
• Effectiveness:
  • Erectile Function Scores: The IIEF-5 scores, which measure erectile function, improved in four of the five patients. The results peaked at 3 months and remained stable until 6 months.
  • Blood Flow: Peak Systolic Velocity (PSV), a measure of blood flow, improved in all patients at the 6-month mark. The End Diastolic Velocity (EDV) was more variable.
  • Patient-Reported Function: Several patients saw significant improvements in their ability to get an erection. Two patients who previously needed injections to achieve an erection could now get one with oral medication, while two others were able to have unassisted erections.

How the Cells Worked

1. Improving blood flow: The increase in PSV suggests that the stem cells had an angiogenic effect. They helped to promote the formation of new blood vessels, which is critical for erectile function.
2. Sending out healing signals: The study suggests the main benefits came from the cells’ ability to send out signals to help the body’s natural healing process. This is known as a paracrine effect. They release factors that promote wound healing and regeneration of damaged tissues. The combined use with platelet lysate plasma, which is rich in growth factors, aimed to increase this effect

What We Don’t Know (Limitations)

• Small Patient Group: With only five patients, the results are preliminary and cannot be applied to a wider population.
• No Control Group: The study did not have a placebo or control group, which makes it impossible to rule out the placebo effect.
• Short-Term Follow-up: This paper only reports 6-month results, so the long-term effects of the treatment are still unknown

Researchers Conclusion

This study provides encouraging initial data on the safety and potential benefits of combining adipose-derived stem cells with platelet lysate plasma to treat erectile dysfunction.

While the results are promising, the researchers stressed that it is still too early to generalize this treatment. They concluded that the therapy should only be used in controlled settings by experts while awaiting a larger, more definitive study.

Reviews looking at Stem Cells treating ED

In science, a review isn’t a single experiment,it’s more like a big-picture summary.

 Instead of testing one small idea, reviews look at lots of different studies on the same topic, gather their results, and explain what the overall evidence shows.

Think of it as reading dozens of studies then pulling out the key takeaways. What’s promising, what’s unclear and where more research is needed

2023 Review on Stem Cells for ED: Spain

The full review was published in the journal Life in 2023.

A team of researchers from Spanish universities and hospitals conducted a literature review on stem cell therapy for erectile dysfunction (ED). They looked at studies from 2010 to 2022 to evaluate the safety and effectiveness of this new field of regenerative medicine.

What They Looked At

The researchers performed a literature search using databases like PubMed and ClinicalTrials.gov to find studies on stem cell therapy for ED. They reviewed a total of 54 studies that met their criteria, prioritizing clinical trials and human studies.

They specifically looked at:

• Cell Sources: The most common sources of stem cells in the reviewed studies were mesenchymal stem cells from bone marrow and fat tissue. They also reviewed studies using MSCs from the umbilical cord and placenta.
• Delivery Methods: The main delivery method was intracavernous injection, which means injecting the cells directly into the penis.

What They Wanted to Find Out

• What is the safety profile of stem cell therapy for ED?
• Do the treatments provide a functional benefit, and can they “cure” the condition rather than just manage symptoms?
• What is the exact mechanism by which stem cells improve erectile function?
• What are the ethical concerns and limitations of the current research?
  

What They Found

1. Effectiveness and Therapeutic Potential
   • Promising Results: The review found that most of the human studies showed promising results, with observed improvements in erectile function based on both patient questionnaires and objective measures like blood flow.
   • Curative Intent: The authors note that unlike traditional drug treatments, stem cell therapy aims to have a curative effect by regenerating damaged tissue.
2. Mechanism of Action
   • Primary Mechanism: The review found that the main source of the therapeutic effect seems to be the paracrine effect. This means the stem cells release a variety of beneficial substances like growth factors and anti-inflammatory agents that help regenerate damaged tissues, improve blood flow, and protect existing cells.
   • Secondary Mechanism: The less-accepted theory is that the stem cells can differentiate into new endothelial and smooth muscle cells to replace damaged ones. While this has been shown in some animal studies, the review suggests it is a minor part of the overall effect.
3. Safety
   • General Safety: The review consistently found that no serious adverse effects were reported from intracavernous injections of MSCs.
   • Placebo Effect: The authors highlight that a significant limitation in the research is the placebo effect, which is very strong in studies on ED. Because many studies lacked a control group, it is difficult to know if the reported improvements were a direct result of the treatment.
4. Ethical Concerns and Limitations
   • Lack of Standardization: The studies reviewed had different protocols, including varying cell sources, doses, and follow-up times. This makes it difficult to draw firm conclusions or replicate results.
   • “Predatory Tourism”: The authors warn against “predatory health-related tourism” where unproven stem cell treatments are marketed to desperate patients. They emphasize that this therapy should only be performed in an experimental, licensed setting.

What They Concluded

• The authors conclude that while stem cell therapy is a promising potential therapy for ED, there is a lack of high-level evidence to support its use as a standard treatment.
• They state that more human research is needed, including large-scale, randomized, placebo-controlled trials that compare stem cell therapy to existing treatments. 
• The ultimate goal is to standardize the manufacturing and administration of stem cell products to ensure consistency and safety for patients

2025 Review of Stem Cells for ED: Turkey & Uzbekistan

The full review was published in the journal BMC Urology in 2025

A team of researchers from medical universities and hospitals in Turkey and Uzbekistan conducted a systematic review and meta-analysis of clinical trials to determine the effectiveness of stem cell therapy for erectile dysfunction.

What They Looked At

The researchers performed a systematic search of databases like PubMed, Web of Science, and Scopus for articles published from January 2000 to May 2024.

They initially identified over 2,000 studies and ultimately included 11 studies in their systematic review, with six of these included in the meta-analysis.

They specifically looked at:

• Cell Sources: The reviewed studies used various types of stem cells, including those from bone marrow, fat tissue, Wharton’s jelly, and oral mucosa.
• Delivery Methods: The meta-analysis focused exclusively on studies where the stem cells were delivered via a direct injection into the penis (intracavernosal injection).
• Outcome Measures: They analyzed patient questionnaires such as the IIEF-5 and EHS, as well as objective measures of blood flow like Peak Systolic Velocity (PSV) and End-Diastolic Velocity (EDV).

What They Wanted to Find Out

• To assess the effectiveness of stem cell therapy for ED.
• To determine if there is a consistent and reliable conclusion about its efficacy by combining the results of multiple clinical trials.
• To evaluate the safety of the treatment based on reported side effects

What They Found

1. Effectiveness and Therapeutic Potential
   • Significant Short-Term Improvement: The meta-analysis found that stem cell therapy resulted in statistically significant improvements in IIEF-5 and EHS scores at six months. It also showed a significant increase in PSV, indicating better penile blood flow.
   • Medium-to-Large Effect: The statistical analysis showed a medium-to-large effect size for improvements in erectile function scores and blood flow after treatment. A score increase of 4–6 points on the IIEF-5 questionnaire was considered a clinically meaningful gain that could move a patient from moderate to mild ED.
   • Temporary Benefits: Some studies noted that the improvements in erectile function began to decline after 6-12 months, suggesting that the benefits might be temporary.
2. Mechanism of Action
   • Paracrine Signaling: The review highlights that the regenerative benefits of stem cell therapy are mostly achieved through paracrine signaling rather than the permanent engraftment of the stem cells themselves. The cells are thought to work by releasing healing factors that induce angiogenesis (new blood vessel formation), suppress cell death, and prevent scar tissue from forming.
3. Safety
   • General Safety: The systematic review found that most trials reported no adverse effects related to the therapy. Minor side effects, such as pain, redness, or discomfort at the injection site, were reported in some trials.
   • Limitations of Safety Data: The authors caution that the small sample sizes and short follow-up periods in these trials limit the ability to draw strong conclusions about long-term safety, such as the potential for fibrosis or immune reactions.
     

What They Concluded

The authors concluded that intracavernosal stem cell therapy for ED shows short-term efficacy, increasing patient questionnaire scores and blood flow at six months.

However, they stressed that the field is not yet ready for widespread clinical use.

They called for larger, more rigorous, and randomized controlled trials with longer follow-up periods to draw more definitive conclusions about the long-term effects of the therapy.

The review highlights the promising potential of the treatment while acknowledging the significant gaps that still need to be addressed by future research.

Conclusion: Stem Cell Research for ED

Research is global, with key clinical studies being conducted in South Korea, the Middle East and Europe. 

Mesenchymal Stem Cells are the most frequently studied cell type. The most common sources are the patient’s own bone marrow and fat tissue. MSCs sourced from the umbilical cord and placenta are also being explored.

The success of the therapy is promising for short-term improvement.
The most common positive results are significant improvements in patient-reported erectile function scores and objective measures of penile blood flow.
However, a key finding across multiple studies is that these benefits are often temporary, with effects beginning to decline after 6 to 12 months.

How it works

The consensus across the research is that the cells work primarily through paracrine signaling. They release healing signals that improve blood flow, protect existing cells and help regenerate damaged tissue. The studies suggest the cells do not work by turning into new penile tissue (a process called differentiation).

Dosages vary between studies, but a common range for a single injection is between 10 million and 50 million cells. Some protocols use multiple injections to deliver the treatment.

Safety is a consistent finding across all reviewed trials. The therapies are reported as safe and well-tolerated, with no serious adverse events attributed to the stem cell injections.

The reviewed literature shows that studies are consistently limited by very small patient numbers, a lack of placebo-control groups and a lack of standardized protocols, making it difficult to draw definitive conclusions.

If you’re thinking about treatment, be aware that commercial clinics won’t always follow the same strict protocols used in these trials. The research warns against “predatory health-related tourism” and emphasizes that this therapy should only be performed in an experimental, licensed setting.