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

NCT ID: NCT07319533

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2027-01-31

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.

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

exosomes derived from human umbilical cord mesenchymal stem cells

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

Normal (0.9%) saline

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Labbafinejad Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Amirhossein Kashi

Doctor Amirhossein Kashi

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shahid Labbafinejad Hospital

Tehran, Tehran Province, Iran

Countries

Iran

Facility Contacts

Amirhossein Kashi, Subspecialist

Role: primary

ahkashi@gmail.com

+982122567222

Other Identifiers

IRCT20160406027253N3

Identifier Type: OTHER

Identifier Source: secondary_id

IR.SBMU.UNRC.REC.1403.015

Identifier Type: -

Identifier Source: org_study_id