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Clinical Trial Summary

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


Clinical Trial 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02945462
Study type Interventional
Source University of Jordan
Contact
Status Completed
Phase Phase 1
Start date September 2013
Completion date October 2016

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