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Safety of Wharton Jelly in Erectile Dysfunction

Primary Purpose

Erectile Dysfunction Associated With Type 2 Diabetes Mellitus

Status

Completed

Phase

Phase 1

Locations

Jordan

Study Type

Interventional

Intervention

Wharton Jelly Mesenchymal stem cells

About this trial

This is an interventional treatment trial for Erectile Dysfunction Associated With Type 2 Diabetes Mellitus focused on measuring Wharton jelly mesenchymal stem cells, Erectile Dysfunction, Diabetes, safety

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
Post-radical prostatectomy.

Sites / Locations

Cell Therapy Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dose I

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Patients will be evaluated for the efficacy of the intracavernous injection of Wharton Jelly derived Mesenchymal Stem Cells by Sexual Health Inventory for Men/International Index of Erectile Function/Erection Hardness Score (SHIM/IIEF/EHS) questionnaire.

Full Information

NCT ID

NCT02945449

First Posted

October 17, 2016

Last Updated

November 13, 2018

Sponsor

Sophia Al-Adwan

1. Study Identification

Unique Protocol Identification Number

NCT02945449

Brief Title

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

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

January 4, 2017 (Actual)

Primary Completion Date

October 15, 2018 (Actual)

Study Completion Date

November 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Sophia Al-Adwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Erectile Dysfunction Associated With Type 2 Diabetes Mellitus

Keywords

Wharton jelly mesenchymal stem cells, Erectile Dysfunction, Diabetes, safety

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dose I

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Wharton Jelly Mesenchymal stem cells

Intervention Description

Intracavernous injection of Wharton Jelly Mesenchymal stem cells.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

12 months

10. Eligibility

Sex

Male

Gender Based

Yes

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. Post-radical prostatectomy.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Abdallah Awidi, MD

Organizational Affiliation

Cell Therapy Center

Official's Role

Study Director

Facility Information:

Facility Name

Cell Therapy Center

City

Amman

ZIP/Postal Code

11942

Country

Jordan

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Safety of Wharton Jelly in Erectile Dysfunction

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