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Efficacy of Wharton Jelly in Erectile Dysfunction

Sponsor
Sophia Al-Adwan (Other)
Overall Status
Completed
CT.gov ID
NCT03751735
Collaborator
(none)
9
Enrollment
1
Location
1
Arm
25
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Efficacy of Intracavernous injection of Wharton jelly Mesenchymal stem cells for the treatment of erectile dysfunction in diabetic patients.

Condition or Disease Intervention/Treatment Phase
  • Biological: Wharton Jelly Mesenchymal stem cells
 Phase 1/Phase 2

Detailed Description

This study will be conducted at the Cell Therapy Center (CTC), Jordan, in which 22 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.

The investigators hypothesize that the intracavernous injection of stem cells will facilitate the recovery of erectile function resulting in satisfying clinical outcomes in patients.

Study Design

Study Type:
Interventional
Actual Enrollment :
9 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of the Efficacy for Two Doses of Intracavernous Injection of Wharton Jelly Stem Cells for the Treatment of Diabetic Erectile Dysfunction
Actual Study Start Date :
Jan 27, 2017
Actual Primary Completion Date :
Jan 13, 2019
Actual Study Completion Date :
Feb 26, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dose 1

Dose I of Wharton Jelly Mesenchymal stem cells (WJ-MSC) Two intracavernous injections of 20 million of WJ-MSC cells will be given to erectile dysfunction patients at baseline and 4th week of follow up

Biological: Wharton Jelly Mesenchymal stem cells
Intracavernous injection of Wharton Jelly Mesenchymal stem cells.

Outcome Measures

Primary Outcome Measures

  1. Assessment of the efficacy of injecting Wharton Jelly derived Mesenchymal Stem Cells by Penile Doppler ultrasonography. [12 months]

    Patients will be evaluated for the efficacy of the intracavernous injection of Wharton Jelly derived Mesenchymal Stem Cells by Penile Doppler ultrasonography in which peak systolic velocity of the cavernosal arteries will be measured.

  2. Assessment of the efficacy of injecting Wharton Jelly derived Mesenchymal Stem Cells by SHIM/IIEF/EHS questionnaires [12 months]

    The efficacy of the intracavernous injection of Wharton Jelly will be evaluated by scoring the SHIM/IIEF/EHS questionnaires.

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 70 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cell Therapy Center Amman Jordan 11942

Sponsors and Collaborators

  • Sophia Al-Adwan

Investigators

  • Study Director: Abdalla Awidi, MD, Cell Therapy Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sophia Al-Adwan, Researcher, Clinical coordinator, University of Jordan
ClinicalTrials.gov Identifier:
NCT03751735
Other Study ID Numbers:
  • WJEF.EDUJCTC
First Posted:
Nov 23, 2018
Last Update Posted:
Apr 10, 2019
Last Verified:
Apr 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sophia Al-Adwan, Researcher, Clinical coordinator, University of Jordan
Diabetes
Wharton jelly mesenchymal stem cells
efficacy
Additional relevant MeSH terms:
Erectile Dysfunction
Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Apr 10, 2019