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Bone Marrow Mesenchymal Stem Cells in Erectile Dysfunction (ED)

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ClinicalTrials.gov Identifier: NCT02945462
Recruitment Status : Completed
First Posted : October 26, 2016
Last Update Posted : November 16, 2016
Sponsor:
Information provided by (Responsible Party):
Saddam Dmour, University of Jordan

Tracking Information
First Submitted Date  ICMJE October 17, 2016
First Posted Date  ICMJE October 26, 2016
Last Update Posted Date November 16, 2016
Study Start Date  ICMJE September 2013
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2016)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: six months ]
Observation of any relevant adverse side effect resulting from the injection. Assessing the safety of autologous Mesenchymal Stem Cells injection
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02945462 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2016)
  • Assessment the efficacy of intracavernous injection measured by SHIM/IIEF/EHS questionnaire [ Time Frame: 18 months ]
    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. [ Time Frame: 6 months ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2016)
  • Assessment the efficacy of intracavernous injection measured by SHIM/IIEF/EHS questionnaire [ Time Frame: 18 months ]
    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 cavernosometry [ Time Frame: 6 months ]
    Assessing the therapeutic benefits of the injected Autologous Mesenchymal Stem Cells by cavernosometry at baseline and repeated at 6 months post injection.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bone Marrow Mesenchymal Stem Cells in Erectile Dysfunction (ED)
Official Title  ICMJE The Safety and Efficacy of Using Bone Marrow-derived Mesenchymal Stem Cells in the Treatment of Erectile Dysfunction in Diabetic Patients
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:

  1. To test the safety of autologous intracavernous bone marrow mesenchymal stem cells.
  2. 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.
  3. To study the feasibility, indication criteria and application modalities of Bone marrow mesenchymal stem cells for further wider study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Erectile Dysfunction
Intervention  ICMJE Biological: autologous mesenchymal stem cells
Patients will be injected with autologous mesenchymal stem cells, intracavernously
Study Arms  ICMJE Experimental: autologous mesenchymal stem cells

Intervention:

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

Intervention: Biological: autologous mesenchymal stem cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 24, 2016)
4
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Adult male patients ranging from 25 to 65 years.
  2. Type 1 or type 2 diabetic patients with a personal history of diabetes ≥ 5 years.
  3. History of chronic erectile dysfunction for at least six months.
  4. HbA1c ≤ 10%.
  5. Baseline International Index of Erectile Function (IIEF) score of < 26.
  6. 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.
  7. Body mass index between 20 -30.
  8. 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. Untreated hypogonadism or low serum total testosterone < 200 ng/dl.
  2. Current urinary tract or bladder infection.
  3. Any medical evidence of any infectious disease.
  4. Clinically evident penile anatomical deformities (e.g., Peyronie's disease) or history of priapism.
  5. Skin irritation, infection, wound, sore or disruption in the immediate areas of skin entry for penile injection.
  6. Current or previous malignancy.
  7. Patients with primary hyperlipidemia.
  8. Use of any non study treatment for erectile dysfunction within 4 weeks of study treatment.
  9. Lack of willingness to continue through 6 months after study treatment.
  10. Any previous penile implant or penile vascular surgery.
  11. Uncontrolled hypertension or hypotension (systolic blood pressure > 170 or < 90 mm Hg, and diastolic blood pressure > 100 or < 50 mm Hg).
  12. 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.
  13. Bleeding or clotting disorder, use of anticoagulant therapy.
  14. 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.
  15. Systemic autoimmune disorder.
  16. Significant active systemic or localized infection.
  17. Receiving immunosuppressant medications.
  18. HbA1c > 10%.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 25 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02945462
Other Study ID Numbers  ICMJE EDUJCTC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Saddam Dmour, University of Jordan
Study Sponsor  ICMJE University of Jordan
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Jordan
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP