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

Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

• Биопрепарат 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.
• Биопрепарат 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.

Первичные конечные точки

• IIEF-5 score [Срок оценки: week 0, 7, 13, 25, 49]

Вторичные конечные точки (6)

• EHS score [Срок оценки: week 0, 7, 13, 25, 49]
• Peak Systolic Voulme [Срок оценки: week 0, 7, 13]
• End Diastolic Volume [Срок оценки: week 0, 7, 13]
• Pulled length of penis [Срок оценки: week 0, 7, 13, 25, 49]
• Erected length of Penis [Срок оценки: week 0, 7, 13, 25, 49]
• Side effects [Срок оценки: week 1, 2, 3, 4, 5, 6]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Иран · 1 центр

• Shahid Labbafinejad Hospital — Tehran

Идентификаторы

NCT: NCT07319533 · IR.SBMU.UNRC.REC.1403.015 · IRCT20160406027253N3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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