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

NCT ID: NCT04972890

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-27
• Study Completion Date: 2023-01-31

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.

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.

Conditions

Urologic Diseases; Erectile Dysfunction With Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control group

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

using 2 cc saline/NaCl 0,9% solution

Stem Cell Group

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

Group Type: EXPERIMENTAL

stem cells

Intervention Type: BIOLOGICAL

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

Interventions

stem cells

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

Intervention Type: BIOLOGICAL

placebo

using 2 cc saline/NaCl 0,9% solution

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Gampo Alam Irdam

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universitas Indonesia

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status: RECRUITING

Countries

Indonesia

Central Contacts

Gampo A Irdam

Role: CONTACT

gampoai@gmail.com

+6281318612618

Febriyani Laurus

Role: CONTACT

febri.laurus@gmail.com

+6281314337727

Facility Contacts

Gampo A Irdam

Role: primary

gampoai@gmail.com

+6281318612618

Other Identifiers

19-04-0516

Identifier Type: -

Identifier Source: org_study_id