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NCT Number: NCT07319533

Clinical Trial Investigating the Effect of Exosomes as a Complementary Treatment in Severe to Moderate Erectile Dysfunction

The goal of this clinical trial is to Investigate the Effect of Injection of MSC-Derived Exosome on Patients with Erectile Dysfunction in overall healthy males, aged 18-70, with-out any severe active medical condition, with moderate to severe erectile dysfunction based on IIEF-5, and non-satisfactory response to other treatments (5PDEI). The main question it aims to answer is:

• Is MSC-derived exosome safe and effective in treating patients with ED by improving IIEF-5 score?

If there is a comparison group: Researchers will compare the intervention group (Exosome receiving group) with control group (placebo receiving group) to see if exosomes are safe and effective in treating male adult patients with moderate-sever ED.

Participants will receive six weekly injections of normal saline or exosome (based on group), and will undergo necessarily follow up, and examinations and observation.

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Key information

Conditions

Erectile Dysfunction Erectile Dysfunction Associated With Type 2 Diabetes Mellitus Erectile Dysfunction Due to Arterial Disease Erectile Dysfunction Due to Arterial Insufficiency Erectile Dysfunction Due to General Medical Condition Erectile Dysfunction Due to Neuropathy Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Shahid Labbafinejad Hospital

Tehran, Tehran Province, 1666663111, Iran

Location contact

Amirhossein Kashi, Subspecialist

CONTACT

[email protected]

+982122567222

About this study

Secondary outcomes are the folllowing:

EHS score length of erected penis lenght of flacid penis (pulled) peak systolic volume (via dupler sonography) end diastolic volume (via dupler sonography) any adverse effects of exosome

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Moderate or severe erectile dysfunction (according to IIEF-5) Non-satisfactory response to other treatments Generally Healthy males Not having severe past medical history

Exclusion criteria

Known allergy or history of hyperactivity to biological substances Peyronie's plaque Existing medical condition (severe or uncontrolled) Use of psychiatric medication Use of thyroid medication Hyopgonadism Hypergonadism Cancer History of prostatectomy Prostitis Autoimmune disease Recent trauma or surgery Ongoing systemic infection Skin lesion or infection at the site of injection

Treatment and study plan

exosomes derived from human umbilical cord mesenchymal stem cells

Biological

Intervention group: patients in this group will be injected 5 ml of exosome in corpus cavernosa of each side (2.5 ml in each side at base of the penis). This will happen once a week, for 6 weeks. Inorder to prevent the injected substance from spreading systemically, a tourniquet will be placed at the base of the penis for 10 minute following injection.

Normal (0.9%) saline

Biological

Control group: these patients will recieve 5 ml of intracavernosal normal saline (2.5 ml in each side of penile base). This will happen once a week, for 6 weeks. Inorder to prevent the injected substance from spreading systemically, a tourniquet will be placed at the base of the penis for 10 minute following injection.

Primary outcomes

  1. IIEF-5 score

    Time frame: week 0, 7, 13, 25, 49

    Erectile dysfunction of the patients during the study will be assessed by IIEF-5 questionnaire. It will done in a interview with the patients.

Secondary outcomes

  1. EHS score

    Time frame: week 0, 7, 13, 25, 49

    Erectile Hardness Score It will be done in a interview with the patients.

  2. Peak Systolic Voulme

    Time frame: week 0, 7, 13

    Peak systolic volum or arterial blood flow of the penis, which will be assessed by doppler sonography after papaverin injection

  3. End Diastolic Volume

    Time frame: week 0, 7, 13

    end diastolic volume or venous blood flow of the penis which will be assessed by doppler sonography after papaverin injection

  4. Pulled length of penis

    Time frame: week 0, 7, 13, 25, 49

    the pulled length of penis which will be assessed by clinician at each follow up session

  5. Erected length of Penis

    Time frame: week 0, 7, 13, 25, 49

    erected length of penis which will be assessed at follow up sessions by clinician

  6. Side effects

    Time frame: week 1, 2, 3, 4, 5, 6

    any immeadiate, or late onset local side effects at injection site. these will be reported both by the patients and assessed by the clinician.

Sponsors and collaborators

Lead sponsor

Labbafinejad Medical Center

Other

Registry information

Official study title

Investigating the Effect of Exosome Derived From Human Fetal Umbilical Cord Mesanchymal Cells as Complimintary Treatment in Moderate to Severe Erectile Dysfunction

Acronym: MSC

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 6, 2026
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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