Clinical trial NCT02945449: Safety of Wharton Jelly in Erectile Dysfunction
Official title: Phase Ib: Evaluation of the Safety and as a Secondary End Point the Efficacy for Two Doses of Wharton Jelly Stem Cells for the Treatment of Diabetic Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Erectile Dysfunction Associated With Type 2 Diabetes Mellitus
Keywords: Wharton jelly mesenchymal stem cells
Erectile Dysfunction
Diabetes
safety
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 9
Sex: MALE
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Safety of Intracavernous injection of Wharton jelly Mesenchymal stem cells for the treatment of erectile dysfunction in diabetic patients.

Detailed description: This study will be conducted at the Cell Therapy Center (CTC), Jordan, in which nine male patients ranging from 25-70 years diagnosed with erectile dysfunction will be selected. This diagnosis is based on medical history, validated questionnaires, physical examinations, laboratory tests and specific diagnostic tests.

The patients are followed by clinical assessment, laboratory investigations as well as Doppler ultrasound.

Eligibility criteria: Inclusion Criteria:

1. Adult male patients ranging from 25 to 70 years.
2. History of chronic erectile dysfunction for at least six months.
3. Baseline international index of erectile function (IIEF) score of \< 26.
4. Not interested or able to use phosphodiesterase type 5 inhibitor (PD5i) drug therapy and willing to forgo theses treatments for the first 6 month period following study treatment.
5. Body Mass Index between 20-30.
6. Willing to provide written informed consent, complete questionnaire, and to be available for all baseline treatment and follow up examinations required by protocol.

Exclusion Criteria:

1. Current urinary tract or bladder infection.
2. Clinical/Laboratory evidence of transmissible diseases.
3. Clinically evident penile anatomical deformities(e.g., Peyronie's disease) or history of priapism.
4. Skin irritation, infection, wound, sore or disruption in the immediate areas of skin entry for penile injection.
5. Current or previous malignancy.
6. Use of any non study treatment for erectile function within 4 weeks of study treatment.
7. Lack of willingness to continue through 6 months after study treatment.
8. Any previous penile implant or penile vascular surgery.
9. Uncontrolled hypertension or hypotension(systolic blood pressure \> 170 or \< 90 mm Hg, and diastolic blood pressure \> 100 or \< 50 mm Hg).
10. Reported unstable cardiovascular disease (e.g., unstable angina, myocardial infarction within past 6 months, cardiac failure or life-threatening arrhythmia, congestive heart failure) or symptomatic postural hypotension within 6 months before screening.
11. Bleeding or clotting disorder, use of anticoagulant therapy.
12. Lab values for complete blood count (CBC), prothrombin time (PT)/ partial thromboplastin time (PTT)/ international normalized ratio (INR), alanine aminotransferase (ALT), aspartate aminotransferase (AST) and creatinine falling outside the normal lab values.
13. Systemic autoimmune disorder.
14. Significant active systemic or localized infection.
15. Receiving immunosuppressant medications.
16. Post-radical prostatectomy.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: 6 months
Secondary outcomes:
measure: Assessment of the efficacy of injecting Wharton Jelly derived Mesenchymal Stem Cells by SHIM/IIEF/EHS questionnaire
timeFrame: 12 months
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Cell Therapy Center
Study officials:
affiliation: Cell Therapy Center
name: Abdallah Awidi, MD
role: STUDY_DIRECTOR
References: