Clinical trial investigating the effect of exosome in patients with peyronie's plaque

Investingating the effect of Exosomes Derived from Human Fetal Umbilical Cord Mesenchymal Stem Cells in Patients with peyronie's plaque

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20160406027253N4

Enrollment

Registered

2025-07-18

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

Peyronie disease. Induration penis plastica

Interventions

Intervention 1: Intervention group: this group will recieve an intralesional injection consisting 5mg of verapamil with 5 ml of exosome (6 injections in total, every other week, in total 12 weeks). In

Eligibility

Sex/Gender

Male

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Males 18-70 years of age Presence of active phase Peyronie’s plaque Generally healthy

Exclusion criteria

Exclusion criteria: Major uncontrolled medical conditions Psychiatric history Active systemic infection Skin infection at the injection or plaque site Use of 5PDEi medications Use of other treatments for Peyronie’s disease Autoimmune diseases History of cancer Known allergy to exosome or Verapamil Use of anabolic steroids or androgens Not willing to participate Recent surgery or trauma

Design outcomes

Primary

Measure	Time frame
IIEF-5 questionare. Timepoint: week 0, 12-13, 24, 48. Method of measurement: Interview and questionnaire.;Plaque size. Timepoint: week 0, 12-13, 24, 48. Method of measurement: Sonography in follow up sessions.;Angle of curvature. Timepoint: week 0, 12-13, 24, 48. Method of measurement: Goniometer in follow up session, using pictures of erected penis.;PDQ score. Timepoint: week 0, 12-13, 24, 48. Method of measurement: Interview.	—

Measure

Time frame

IIEF-5 questionare. Timepoint: week 0, 12-13, 24, 48. Method of measurement: Interview and questionnaire.;Plaque size. Timepoint: week 0, 12-13, 24, 48. Method of measurement: Sonography in follow up sessions.;Angle of curvature. Timepoint: week 0, 12-13, 24, 48. Method of measurement: Goniometer in follow up session, using pictures of erected penis.;PDQ score. Timepoint: week 0, 12-13, 24, 48. Method of measurement: Interview.

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Secondary

Measure	Time frame
Venous blood flow of the penis. Timepoint: week 0, 24. Method of measurement: Doppler sonography with papaverine.;Arterial blood flow of the penis. Timepoint: week 0, 24. Method of measurement: Doppler sonography with papaverine.;Side effects. Timepoint: week 1-12, 13, 24, 48. Method of measurement: Interview and physical examination.;VAS questionare. Timepoint: week 0, 12-13, 24, 48. Method of measurement: Interview.;Flaccid penile length. Timepoint: week 0, 12-13, 24, 48. Method of measurement: Interview and physical examination.;Erected penile length. Timepoint: week 0, 12-13, 24, 48. Method of measurement: Interview and physical examination.	—

Measure

Time frame

Venous blood flow of the penis. Timepoint: week 0, 24. Method of measurement: Doppler sonography with papaverine.;Arterial blood flow of the penis. Timepoint: week 0, 24. Method of measurement: Doppler sonography with papaverine.;Side effects. Timepoint: week 1-12, 13, 24, 48. Method of measurement: Interview and physical examination.;VAS questionare. Timepoint: week 0, 12-13, 24, 48. Method of measurement: Interview.;Flaccid penile length. Timepoint: week 0, 12-13, 24, 48. Method of measurement: Interview and physical examination.;Erected penile length. Timepoint: week 0, 12-13, 24, 48. Method of measurement: Interview and physical examination.

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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