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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04972890
Recruitment Status : Recruiting
First Posted : July 22, 2021
Last Update Posted : March 31, 2022
Sponsor:
Information provided by (Responsible Party):
Gampo Alam Irdam, Indonesia University

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.

Condition or disease Intervention/treatment Phase
Urologic Diseases Erectile Dysfunction With Diabetes Mellitus Biological: stem cells Other: placebo Phase 2 Phase 3

Detailed Description:

Prior to conducting clinical trials, researchers asked for written informed consent. If the subject agrees, the study will direct the subject and control to collect basic data in the form of vital signs, blood pressure, filling out the IIEF-5 questionnaire, complete blood count (CBC), lipid profile, fasting blood glucose, HbA1c, and total testosterone, biomarker examination (E-Selectin), VEGF, Bcl-2, miRNA 16, miRNA 126), and penile Doppler ultrasound. The diagnosis of erectile dysfunction was made on the basis of an IIEF-5 score <22.

Penile Doppler ultrasound was performed by a senior radiologist with interpretation of the ultrasound images performed and reported in a blinded fashion (the reader/interpreter does not know the patient's complaints). Penile Doppler ultrasound examination was performed under flaccid conditions and post-sexual stimulation conditions. Prior to the examination, the patient was given sildenafil 100 mg orally, then the flaccid phase was examined. Patients were asked to perform sexual stimulation of themselves and measurements were taken afterwards.

Parallel with the patient recruitment, stem cells processing was carried out based on the production method using xeno-free material.

At the baseline, patient receive intracavernous injection procedure, as a following steps:

  • The base of the penis is clamped with ethiloop before the injection is performed.
  • Intracavernous injection was performed in each body of 7.5 x 10^6 cells/1cc.
  • Clamps are removed after 30 minutes post-injection to increase stem cell residency and grafting time.

After the procedure, we monitor the symptoms for 1 hour to assess the presence or absence of complications before the subject can go home.

We also administer PDE-5 inhibitor to all research subjects, namely tadalafil at a dose of 1 x 2.5 mg for 3 months.

Follow-up was carried out on all subjects both from the experimental group and the control group by evaluating parameters consisting of IIEF-5, DPL, Lipid profile, HbA1c, GDS, total testosterone, Doppler ultrasound, e-selectin, Bcl-2, VEGF, miRNA 16, miRNA 126 at first and third month after baseline.

After all data have been collected, we will perform data analysis and make research report.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Outcomes of Intracavernosal Umbilical Cord Mesenchymal Stem Cells Implantation in Patients With Diabetic Erectile Dysfunction
Actual Study Start Date : October 27, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : January 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control group
with 2cc saline/NaCl 0,9% solution once at baseline
Other: placebo
using 2 cc saline/NaCl 0,9% solution

Experimental: Stem Cell Group
with umbilical cord stem cells 15x10^6 cells in 2 cc saline/NaCl 0,9% solution once at baseline
Biological: stem cells
Using umbilical cord stem cells 15x10^6 cells in 2 cc saline/NaCl 0,9% solution




Primary Outcome Measures :
  1. Changes in IIEF-5 Score after stem cells injection [ Time Frame: The questionnaire will be completed at baseline, 1st month, and 3rd month ]
    using IIEF-5 Questionnaire [numeric scale from 0 to 25] higher IIEF-5 Score means better erectile function

  2. Changes in Peak Systolic Velocity (PSV) after stem cells injection [ Time Frame: The evaluation will be completed at baseline, 1st month, and 3rd month ]
    evaluated by penile doppler ultrasound [ numeric scale in cm/s] The normal value is 35cm/s, PSV <35cm/s means worse erectile function

  3. Changes in End Diastolic Velocity after stem cells injection [ Time Frame: The evaluation will be completed at baseline, 1st month, and 3rd month ]
    evaluated by penile doppler ultrasound [ numeric scale in cm/s] The normal value is 5 cm/s, EDV >5cm/s means worse erectile function

  4. Changes in Resistive Index after stem cells injection [ Time Frame: The evaluation will be completed at baseline, 1st month, and 3rd month ]
    evaluated by penile doppler ultrasound [numeric scale] The normal value is >0.9, if RI<0.75 means worse erectile function

  5. Changes in Pulsatility Index after stem cells injection [ Time Frame: The evaluation will be completed at baseline, 1st month, and 3rd month ]
    evaluated by penile doppler ultrasound [numeric scale]

  6. Changes in E-selectin expression after stem cells injection [ Time Frame: The evaluation will be completed at baseline, 1st month, and 3rd month ]
    evaluated by biomolecular examination using blood sample [numeric scale]

  7. Changes in Vascular Endothelial Growth Factor (VEGF) expression after stem cells injection [ Time Frame: The evaluation will be completed at baseline, 1st month, and 3rd month ]
    evaluated by biomolecular examination using blood sample [numeric scale]

  8. Changes in Bcl-2 expression after stem cells injection [ Time Frame: The evaluation will be completed at baseline, 1st month, and 3rd month ]
    evaluated by biomolecular examination using blood sample [numeric scale]

  9. Changes in microRNA 16 expression after stem cells injection [ Time Frame: The evaluation will be completed at baseline, 1st month, and 3rd month ]
    evaluated by biomolecular examination using blood sample [numeric scale]

  10. Changes in microRNA 126 expression after stem cells injection [ Time Frame: The evaluation will be completed at baseline, 1st month, and 3rd month ]
    evaluated by biomolecular examination using blood sample [numeric scale]


Secondary Outcome Measures :
  1. Changes in Hba1c after stem cells injection [ Time Frame: The evaluation will be completed at baseline and 3rd month ]
    using blood sample [numeric scale in %]

  2. Changes in Fasting Blood Glucose after stem cells injection [ Time Frame: The evaluation will be completed at baseline and 3rd month ]
    using blood sample [numeric scale in mg/dL]

  3. Changes in total cholesterol after stem cells injection [ Time Frame: The evaluation will be completed at baseline, 1st month, and 3rd month ]
    using blood sample [numeric scale in mg/dL]

  4. Changes in low-density lipoprotein (LDL) after stem cells injection [ Time Frame: The evaluation will be completed at baseline, 1st month, and 3rd month ]
    using blood sample [numeric scale in mg/dL]

  5. Changes in high-density lipoprotein (HDL) after stem cells injection [ Time Frame: The evaluation will be completed at baseline, 1st month, and 3rd month ]
    using blood sample [numeric scale in mg/dL]

  6. Changes in Triglycerides (TG) level after stem cells injection [ Time Frame: The evaluation will be completed at baseline, 1st month, and 3rd month ]
    using blood sample [numeric scale in mg/dL]

  7. Number of participants with side effects after intracavernosal injection [ Time Frame: The evaluation will be completed at baseline after the injection ]
    To evaluate the number of participants with side effects including: pain, swelling, bleeding, hypesthesia, and voiding difficulty after the injection.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04972890


Contacts
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Contact: Gampo A Irdam +6281318612618 gampoai@gmail.com
Contact: Febriyani Laurus +6281314337727 febri.laurus@gmail.com

Locations
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Indonesia
Universitas Indonesia Recruiting
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
Contact: Gampo A Irdam    +6281318612618    gampoai@gmail.com   
Principal Investigator: Gampo A Irdam         
Sponsors and Collaborators
Indonesia University
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Responsible Party: Gampo Alam Irdam, Lecturer, Indonesia University
ClinicalTrials.gov Identifier: NCT04972890    
Other Study ID Numbers: 19-04-0516
First Posted: July 22, 2021    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Erectile Dysfunction
Urologic Diseases
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders