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Bone Marrow Mesenchymal Stem Cells in Erectile Dysfunction (ED)

Primary Purpose

Erectile Dysfunction

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

autologous mesenchymal stem cells

About this trial

This is an interventional treatment trial for Erectile Dysfunction

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Adult male patients ranging from 25 to 65 years.
Type 1 or type 2 diabetic patients with a personal history of diabetes ≥ 5 years.
History of chronic erectile dysfunction for at least six months.
HbA1c ≤ 10%.
Baseline International Index of Erectile Function (IIEF) score of < 26.
Not interested or able to use Phosphodiesterase type 5 inhibitor (PDE-5i) drug therapy and willing to forgo these 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:

Untreated hypogonadism or low serum total testosterone < 200 ng/dl.
Current urinary tract or bladder infection.
Any medical evidence of any infectious disease.
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.
Patients with primary hyperlipidemia.
Use of any non study treatment for erectile dysfunction 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, prothrombin time/ partial thromboplastin time/international randomized ratio (PT/PTT/INR), Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and creatinine falling outside the normal lab values.
Systemic autoimmune disorder.
Significant active systemic or localized infection.
Receiving immunosuppressant medications.
HbA1c > 10%.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

autologous mesenchymal stem cells

Arm Description

Intervention: Autologous bone marrow derived stem cells will be injected twice intracavernously to enrolled erectile dysfunction patients

Outcomes

Primary Outcome Measures

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

Observation of any relevant adverse side effect resulting from the injection. Assessing the safety of autologous Mesenchymal Stem Cells injection

Secondary Outcome Measures

Assessment the efficacy of intracavernous injection measured by SHIM/IIEF/EHS questionnaire

Assessing the therapeutic benefits of the injected Autologous Mesenchymal Stem Cells by Sexual Health Inventory for Men/ International Index for Erectile Function/ Erection Hardness Score (SHIM/IIEF/EHS) questionnaire. For every patient tests would be performed at baseline and repeated at 1,3, 6,12, and 18 months post-injection.

Evaluation the efficacy of intracavernous injection measured by Dynamic Infusion cavernosometry test.

Assessing the therapeutic benefits of the injected Autologous Mesenchymal Stem Cells by Dynamic Infusion Cavernosometry test at baseline and repeated at 6 months post injection.

Full Information

NCT ID

NCT02945462

First Posted

October 17, 2016

Last Updated

November 15, 2016

Sponsor

University of Jordan

1. Study Identification

Unique Protocol Identification Number

NCT02945462

Brief Title

Bone Marrow Mesenchymal Stem Cells in Erectile Dysfunction (ED)

Official Title

The Safety and Efficacy of Using Bone Marrow-derived Mesenchymal Stem Cells in the Treatment of Erectile Dysfunction in Diabetic Patients

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

September 2013 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Jordan

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Recovery of erectile function using bone marrow mesenchymal stem cells (MSCs) after in vitro expansion under restricted culturing conditions.

Detailed Description

Four diabetic male patients ranging from 25-65 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. Patients with any evidence of untreated hypogonadism, current urinary tract or bladder infection, clinically evident penile anatomical deformities, previous penile implant or penile vascular surgery, uncontrolled hypertension or hypotension, reported unstable Cardiovascular diseases, uncontrolled diabetes (HbA1c > 10%), or primary hyperlipidemia will be excluded. The investigators hypothesize that the intracavernous injection of stem cells will facilitate the recovery of erectile function resulting in satisfying clinical outcomes in patients. This study was performed: To test the safety of autologous intracavernous bone marrow mesenchymal stem cells. To evaluate benefit for the patient concerning recovery of natural erection by performing detailed and specific diagnostic tests prior and post MSCs injection by a team from Jordan University Hospital and Cell Therapy Center in Jordan University. To study the feasibility, indication criteria and application modalities of Bone marrow mesenchymal stem cells for further wider study.

6. Conditions and Keywords

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

Erectile Dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

autologous mesenchymal stem cells

Arm Type

Experimental

Arm Description

Intervention: Autologous bone marrow derived stem cells will be injected twice intracavernously to enrolled erectile dysfunction patients

Intervention Type

Biological

Intervention Name(s)

autologous mesenchymal stem cells

Intervention Description

Patients will be injected with autologous mesenchymal stem cells, intracavernously

Primary Outcome Measure Information:

Title

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

Description

Observation of any relevant adverse side effect resulting from the injection. Assessing the safety of autologous Mesenchymal Stem Cells injection

Time Frame

six months

Secondary Outcome Measure Information:

Title

Assessment the efficacy of intracavernous injection measured by SHIM/IIEF/EHS questionnaire

Description

Time Frame

18 months

Title

Evaluation the efficacy of intracavernous injection measured by Dynamic Infusion cavernosometry test.

Description

Assessing the therapeutic benefits of the injected Autologous Mesenchymal Stem Cells by Dynamic Infusion Cavernosometry test at baseline and repeated at 6 months post injection.

Time Frame

6 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult male patients ranging from 25 to 65 years. Type 1 or type 2 diabetic patients with a personal history of diabetes ≥ 5 years. History of chronic erectile dysfunction for at least six months. HbA1c ≤ 10%. Baseline International Index of Erectile Function (IIEF) score of < 26. Not interested or able to use Phosphodiesterase type 5 inhibitor (PDE-5i) drug therapy and willing to forgo these 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: Untreated hypogonadism or low serum total testosterone < 200 ng/dl. Current urinary tract or bladder infection. Any medical evidence of any infectious disease. 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. Patients with primary hyperlipidemia. Use of any non study treatment for erectile dysfunction 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, prothrombin time/ partial thromboplastin time/international randomized ratio (PT/PTT/INR), Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and creatinine falling outside the normal lab values. Systemic autoimmune disorder. Significant active systemic or localized infection. Receiving immunosuppressant medications. HbA1c > 10%.

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Bone Marrow Mesenchymal Stem Cells in Erectile Dysfunction (ED)

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