NCT02945449

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 26, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 4, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2018

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

November 15, 2018

Status Verified

November 1, 2018

Enrollment Period

1.8 years

First QC Date

October 17, 2016

Last Update Submit

November 13, 2018

Conditions

Erectile Dysfunction Associated With Type 2 Diabetes Mellitus

Keywords

Wharton jelly mesenchymal stem cellsErectile DysfunctionDiabetessafety

Outcome Measures

Primary Outcomes (1)

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Patients will be assessed for any relevant adverse event resulting from the intracavernous injection of the Wharton jelly mesenchymal stem cells.

    6 months

Secondary Outcomes (1)

  • Assessment of the efficacy of injecting Wharton Jelly derived Mesenchymal Stem Cells by SHIM/IIEF/EHS questionnaire

    12 months

Study Arms (1)

Dose I

EXPERIMENTAL

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

Interventions

Wharton Jelly Mesenchymal stem cellsBIOLOGICAL

Intracavernous injection of Wharton Jelly Mesenchymal stem cells.

Dose I

Eligibility Criteria

Age25 Years - 70 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult male patients ranging from 25 to 70 years.
  • History of chronic erectile dysfunction for at least six months.
  • Baseline international index of erectile function (IIEF) score of \< 26.
  • 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.
  • Body Mass Index between 20-30.
  • Willing to provide written informed consent, complete questionnaire, and to be available for all baseline treatment and follow up examinations required by protocol.

You may not qualify if:

  • Current urinary tract or bladder infection.
  • Clinical/Laboratory evidence of transmissible diseases.
  • Clinically evident penile anatomical deformities(e.g., Peyronie's disease) or history of priapism.
  • Skin irritation, infection, wound, sore or disruption in the immediate areas of skin entry for penile injection.
  • Current or previous malignancy.
  • Use of any non study treatment for erectile function within 4 weeks of study treatment.
  • Lack of willingness to continue through 6 months after study treatment.
  • Any previous penile implant or penile vascular surgery.
  • Uncontrolled hypertension or hypotension(systolic blood pressure \> 170 or \< 90 mm Hg, and diastolic blood pressure \> 100 or \< 50 mm Hg).
  • 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.
  • Bleeding or clotting disorder, use of anticoagulant therapy.
  • 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.
  • Systemic autoimmune disorder.
  • Significant active systemic or localized infection.
  • Receiving immunosuppressant medications.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cell Therapy Center

Amman, 11942, Jordan

Location

MeSH Terms

Conditions

Erectile DysfunctionDiabetes Mellitus

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental DisordersGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Abdallah Awidi, MD

    Cell Therapy Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Researcher, Msc

Study Record Dates

First Submitted

October 17, 2016

First Posted

October 26, 2016

Study Start

January 4, 2017

Primary Completion

October 15, 2018

Study Completion

November 1, 2018

Last Updated

November 15, 2018

Record last verified: 2018-11

Locations

JO(1)