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Urologic DiseasesPhase 2/3NCT04972890

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

A Phase 2/3 study testing stem cells in people with Urologic Diseases and Erectile Dysfunction With Diabetes Mellitus, run by Universitas Indonesia at 1 site in Indonesia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years, men only
What is being tested?
stem cells
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12 participants
Where
1 siteIndonesia
Study dates
27 Oct 2020to 31 Jan 2023
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Gampo A Irdam contact

+6281318612618

gampoai@gmail.com

Febriyani Laurus contact

+6281314337727

febri.laurus@gmail.com

Indonesia1 site, 1 recruiting

  • Universitas Indonesia

    Jakarta Pusat, DKI Jakarta, 10430

    Gampo A Irdam, +6281318612618, gampoai@gmail.com

    Gampo A Irdam

    Recruiting

Other trials in Indonesia

About this study

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.

Read the 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.

Being tested
stem cells, placebo
Medical subject headings
Urologic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • stem cellsBiological

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

  • placeboOther

    using 2 cc saline/NaCl 0,9% solution

Study groups in NCT04972890
Study groupRoleWhat they receive
Control groupPlacebo comparatorwith 2cc saline/NaCl 0,9% solution once at baseline
Receives: Other: placebo
Stem Cell GroupExperimentalwith umbilical cord stem cells 15x10^6 cells in 2 cc saline/NaCl 0,9% solution once at baseline
Receives: Biological: stem cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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

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

  3. 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

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

  4. 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

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

  5. Changes in Pulsatility Index after stem cells injection

    evaluated by penile doppler ultrasound [numeric scale]

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

  6. Changes in E-selectin expression after stem cells injection

    evaluated by biomolecular examination using blood sample [numeric scale]

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

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

    evaluated by biomolecular examination using blood sample [numeric scale]

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

  8. Changes in Bcl-2 expression after stem cells injection

    evaluated by biomolecular examination using blood sample [numeric scale]

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

  9. Changes in microRNA 16 expression after stem cells injection

    evaluated by biomolecular examination using blood sample [numeric scale]

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

  10. Changes in microRNA 126 expression after stem cells injection

    evaluated by biomolecular examination using blood sample [numeric scale]

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

Secondary outcomes (7)

  1. Changes in Hba1c after stem cells injection

    using blood sample [numeric scale in %]

    Measured: The evaluation will be completed at baseline and 3rd month

  2. Changes in Fasting Blood Glucose after stem cells injection

    using blood sample [numeric scale in mg/dL]

    Measured: The evaluation will be completed at baseline and 3rd month

  3. Changes in total cholesterol after stem cells injection

    using blood sample [numeric scale in mg/dL]

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

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

    using blood sample [numeric scale in mg/dL]

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

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

    using blood sample [numeric scale in mg/dL]

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

  6. Changes in Triglycerides (TG) level after stem cells injection

    using blood sample [numeric scale in mg/dL]

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

  7. Number of participants with side effects after intracavernosal injection

    To evaluate the number of participants with side effects including: pain, swelling, bleeding, hypesthesia, and voiding difficulty after the injection.

    Measured: The evaluation will be completed at baseline after the injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2021
  2. Study start27 Oct 2020
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Jan 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04972890
Sponsor's protocol ID
19-04-0516
Status last verified
Mar 2022
First submitted
6 Jul 2021
Last updated
31 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing stem cells in people with Urologic Diseases and Erectile Dysfunction With Diabetes Mellitus, run by Universitas Indonesia at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gampo A Irdam (+6281318612618, gampoai@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in IIEF-5 Score after stem cells injection (time frame: The questionnaire will be completed at baseline, 1st month, and 3rd month). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04972890.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.

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