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

NCT07319533 | Not Yet Recruiting Phase 2

• 2 other identifiers: IR.SBMU.UNRC.REC.1403.015IRCT20160406027253N3
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Erectile Dysfunction Due to Neuropathy; 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

Keywords

Erectile Dysfunction; Exosome; Mesanchymal Stem Cell; MSC

Outcome Measures

Primary Outcomes (1)

• IIEF-5 score

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

  week 0, 7, 13, 25, 49

Secondary Outcomes (6)

• EHS score

  week 0, 7, 13, 25, 49

• Peak Systolic Voulme

  week 0, 7, 13

• End Diastolic Volume

  week 0, 7, 13

• Pulled length of penis

  week 0, 7, 13, 25, 49

• Erected length of Penis

  week 0, 7, 13, 25, 49

Study Arms (2)

Intervention (Exosome)

EXPERIMENTAL

patients in this arm 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.

Biological: exosomes derived from human umbilical cord mesenchymal stem cells

Control

PLACEBO COMPARATOR

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.

Biological: Normal (0.9%) saline

Interventions

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.

Intervention (Exosome)

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.

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Labbafinejad Medical Center: lead

Study Sites (1)

Shahid Labbafinejad Hospital

Tehran, Tehran Province, 1666663111, Iran

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor Amirhossein Kashi

Model Details: A single blinded randomized clinical trail with a placebo-controlled group, consisting 70 patients in total (35 patients in each arm)

Study Record Dates

• First Submitted: December 21, 2025
• First Posted: January 6, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 6, 2026

Record last verified: 2025-12

Locations

IR (1)