The Outcomes of Intracavernosal Umbilical Cord Mesenchymal Stem Cells Implantation in Patients With Diabetic Erectile Dysfunction

NCT04972890 | Unknown Phase 2

• 1 other identifier: 19-04-0516
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Erectile dysfunction (ED) is a complex condition affecting men worldwide. Diabetes mellitus (DM) is one of the most common causes of ED. The prevalence of ED in DM varies around 35-85%. Recently, stem cell therapy has started to become the focus of experimental and clinical studies for the treatment of ED. Stem cells have been shown to be able to regenerate functionally damaged tissue, depending on the stimuli or signals received. Stem cells studies in experimental animals have been carried out using biomarker parameters, including VEGF, Bcl-2, E-selectin, cGMP, eNOS and have been shown to be successful in increasing cell survival and angiogenesis, stimulating antiapoptotic, proneurogenic, proinflammatory, and antifibrotic effects and improvements to these biomarker parameters. This study aims to determine the efficacy, mechanism of action, and safety of umbilical cord mesenchymal stem cells as a therapy for ED due to type 2 diabetes in human.

Conditions

Urologic Diseases; Erectile Dysfunction With Diabetes Mellitus

Outcome Measures

Primary Outcomes (10)

• Changes in IIEF-5 Score after stem cells injection

  using IIEF-5 Questionnaire \[numeric scale from 0 to 25\] higher IIEF-5 Score means better erectile function

  The questionnaire will be completed at baseline, 1st month, and 3rd month

• Changes in Peak Systolic Velocity (PSV) after stem cells injection

  evaluated by penile doppler ultrasound \[ numeric scale in cm/s\] The normal value is 35cm/s, PSV \<35cm/s means worse erectile function

  The evaluation will be completed at baseline, 1st month, and 3rd month

• Changes in End Diastolic Velocity after stem cells injection

  evaluated by penile doppler ultrasound \[ numeric scale in cm/s\] The normal value is 5 cm/s, EDV \>5cm/s means worse erectile function

  The evaluation will be completed at baseline, 1st month, and 3rd month

• Changes in Resistive Index after stem cells injection

  evaluated by penile doppler ultrasound \[numeric scale\] The normal value is \>0.9, if RI\<0.75 means worse erectile function

  The evaluation will be completed at baseline, 1st month, and 3rd month

• Changes in Pulsatility Index after stem cells injection

  evaluated by penile doppler ultrasound \[numeric scale\]

  The evaluation will be completed at baseline, 1st month, and 3rd month

• Changes in E-selectin expression after stem cells injection

  evaluated by biomolecular examination using blood sample \[numeric scale\]

  The evaluation will be completed at baseline, 1st month, and 3rd month

• Changes in Vascular Endothelial Growth Factor (VEGF) expression after stem cells injection

  evaluated by biomolecular examination using blood sample \[numeric scale\]

  The evaluation will be completed at baseline, 1st month, and 3rd month

• Changes in Bcl-2 expression after stem cells injection

  evaluated by biomolecular examination using blood sample \[numeric scale\]

  The evaluation will be completed at baseline, 1st month, and 3rd month

• Changes in microRNA 16 expression after stem cells injection

  evaluated by biomolecular examination using blood sample \[numeric scale\]

  The evaluation will be completed at baseline, 1st month, and 3rd month

• Changes in microRNA 126 expression after stem cells injection

  evaluated by biomolecular examination using blood sample \[numeric scale\]

  The evaluation will be completed at baseline, 1st month, and 3rd month

Secondary Outcomes (7)

• Changes in Hba1c after stem cells injection

  The evaluation will be completed at baseline and 3rd month

• Changes in Fasting Blood Glucose after stem cells injection

  The evaluation will be completed at baseline and 3rd month

• Changes in total cholesterol after stem cells injection

  The evaluation will be completed at baseline, 1st month, and 3rd month

• Changes in low-density lipoprotein (LDL) after stem cells injection

  The evaluation will be completed at baseline, 1st month, and 3rd month

• Changes in high-density lipoprotein (HDL) after stem cells injection

  The evaluation will be completed at baseline, 1st month, and 3rd month

Study Arms (2)

Control group

PLACEBO COMPARATOR

with 2cc saline/NaCl 0,9% solution once at baseline

Other: placebo

Stem Cell Group

EXPERIMENTAL

with umbilical cord stem cells 15x10\^6 cells in 2 cc saline/NaCl 0,9% solution once at baseline

Biological: stem cells

Interventions

stem cells BIOLOGICAL

Using umbilical cord stem cells 15x10\^6 cells in 2 cc saline/NaCl 0,9% solution

Stem Cell Group

placebo OTHER

using 2 cc saline/NaCl 0,9% solution

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years old
• willing to participate as research subject
• patient with erectile dysfunction and Diabetes Mellitus type 2 with IIEF-5 score \<22
• patient has sexual partner and sexually active
• patient is currently not consuming PDE-5 inhibitor drugs

You may not qualify if:

• patient has psychopathology and/or mental retardation
• patient with Peyronie's disease
• patient with hypogonadism
• patient has malignancy in urological and non urological fields
• patient has history of cardiovascular disease with intermediate and high risk

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

RECRUITING

MeSH Terms

Conditions

Urologic Diseases

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Gampo A Irdam

CONTACT

+6281318612618; gampoai@gmail.com

Febriyani Laurus

CONTACT

+6281314337727; febri.laurus@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 22, 2021
• Study Start: October 27, 2020
• Primary Completion: December 31, 2022
• Study Completion: January 31, 2023
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

ID (1)