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Erectile DysfunctionPhase 2MSCNCT07319533

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

A Phase 2 study testing exosomes derived from human umbilical cord mesenchymal stem cells and Normal (0.9%) saline in people with Erectile Dysfunction and Erectile Dysfunction Associated With Type 2 Diabetes Mellitus, run by Labbafinejad Medical Center at 1 site in Iran.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years, men only
What is being tested?
exosomes derived from human umbilical cord mesenchymal stem cells and Normal (0.9%) saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
1 siteIran
Study dates
Jan 2026to Jan 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Iran1 site

  • Shahid Labbafinejad Hospital

    Tehran, Tehran Province, 1666663111

    Amirhossein Kashi, Subspecialist, +982122567222, ahkashi@gmail.com

Other trials in Iran

About this study

Official title: 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?
Read more

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.

Read the 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

Being tested
exosomes derived from human umbilical cord mesenchymal stem cells, Normal (0.9%) saline
Keywords
Erectile Dysfunction, Exosome, Mesanchymal Stem Cell, MSC
Medical subject headings
Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • exosomes derived from human umbilical cord mesenchymal stem cellsBiological

    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%) salineBiological

    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.

Study groups in NCT07319533
Study groupRoleWhat they receive
Intervention (Exosome)Experimentalpatients 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.
Receives: Biological: exosomes derived from human umbilical cord mesenchymal stem cells
ControlPlacebo comparatorControl 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.
Receives: Biological: Normal (0.9%) saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: week 0, 7, 13, 25, 49

Secondary outcomes (6)

  1. EHS score

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

    Measured: week 0, 7, 13, 25, 49

  2. Peak Systolic Voulme

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

    Measured: week 0, 7, 13

  3. End Diastolic Volume

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

    Measured: week 0, 7, 13

  4. Pulled length of penis

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

    Measured: week 0, 7, 13, 25, 49

  5. Erected length of Penis

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

    Measured: week 0, 7, 13, 25, 49

  6. Side effects

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

    Measured: week 1, 2, 3, 4, 5, 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2026
  2. Study startJan 2026 (estimated)
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A single blinded randomized clinical trail with a placebo-controlled group, consisting 70 patients in total (35 patients in each arm)
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07319533
Sponsor's protocol ID
IR.SBMU.UNRC.REC.1403.015
Other IDs
IRCT20160406027253N3
Acronym
MSC
Status last verified
Dec 2025
First submitted
21 Dec 2025
Last updated
6 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: It is not yet known if there will be a plan to make this available.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing exosomes derived from human umbilical cord mesenchymal stem cells and Normal (0.9%) saline in people with Erectile Dysfunction and Erectile Dysfunction Associated With Type 2 Diabetes Mellitus, run by Labbafinejad Medical Center at 1 site in Iran.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

IIEF-5 score (time frame: week 0, 7, 13, 25, 49). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07319533.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.

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