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

December 21, 2025 updated by: Amirhossein Kashi, Labbafinejad Medical Center

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran
    • Tehran Province
      • Tehran, Tehran Province, Iran, 1666663111
        • Shahid Labbafinejad Hospital
        • Contact:
          • Amirhossein Kashi, Subspecialist
          • Phone Number: +982122567222
          • Email: ahkashi@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention (Exosome)
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
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.
Placebo Comparator: Control
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
week 0, 7, 13, 25, 49

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EHS score
Time Frame: week 0, 7, 13, 25, 49
Erectile Hardness Score It will be done in a interview with the patients.
week 0, 7, 13, 25, 49
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
week 0, 7, 13
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
week 0, 7, 13
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
week 0, 7, 13, 25, 49
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
week 0, 7, 13, 25, 49
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.
week 1, 2, 3, 4, 5, 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Labbafinejad Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

December 21, 2025

First Submitted That Met QC Criteria

December 21, 2025

First Posted (Actual)

January 6, 2026

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

December 21, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IR.SBMU.UNRC.REC.1403.015
  • IRCT20160406027253N3 (Other Identifier: IRCT (Iranian Registary ofClinical Trials))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

It is not yet known if there will be a plan to make this available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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