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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20160406027253N3

Enrollment

Registered

2025-06-08

Start date

2025-07-23

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction. Impotence of organic origin

Interventions

Intervention 1: 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, f

Eligibility

Sex/Gender

Male

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Moderate or severe erectile dysfunction Non-satisfactory response to other treatments Generally Healthy males Not having severe past medical history

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
IIEF-5. Timepoint: week 0, 7, 13, 25, 49. Method of measurement: Interview and questionare.;EHS (erectile hardness score). Timepoint: week 0, 7, 13, 25, 49. Method of measurement: Interview and questionare.;Pulled lenght of penis. Timepoint: week 0, 7, 13, 25, 49. Method of measurement: Interview and physical examination.;Erected lenght of penis. Timepoint: week 0, 7, 13, 25, 49. Method of measurement: Interview and physical examination.;Venous blood flow (end diastolic volume). Timepoint: week 0, 7, 13. Method of measurement: Doppler sonography after papaverin injection.;Arterial blood flow (peak systolic volume). Timepoint: Week 0, 7, 13. Method of measurement: Doppler sonography after papaverin injection.	—

Measure

Time frame

IIEF-5. Timepoint: week 0, 7, 13, 25, 49. Method of measurement: Interview and questionare.;EHS (erectile hardness score). Timepoint: week 0, 7, 13, 25, 49. Method of measurement: Interview and questionare.;Pulled lenght of penis. Timepoint: week 0, 7, 13, 25, 49. Method of measurement: Interview and physical examination.;Erected lenght of penis. Timepoint: week 0, 7, 13, 25, 49. Method of measurement: Interview and physical examination.;Venous blood flow (end diastolic volume). Timepoint: week 0, 7, 13. Method of measurement: Doppler sonography after papaverin injection.;Arterial blood flow (peak systolic volume). Timepoint: Week 0, 7, 13. Method of measurement: Doppler sonography after papaverin injection.

—

Secondary

Measure	Time frame
Side effects. Timepoint: week 1, 2, 3, 4, 5, 6. Method of measurement: Interview and physical examination.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Amirhossein Kashi

Shahid Beheshti University of Medical Sciences

ahkashi@gmail.com+98 21 2258 8016

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026