Erectile Dysfunction Clinical Trial
Official title:
The Safety and Efficacy of Using Bone Marrow-derived Mesenchymal Stem Cells in the Treatment of Erectile Dysfunction in Diabetic Patients
Recovery of erectile function using bone marrow mesenchymal stem cells (MSCs) after in vitro expansion under restricted culturing conditions.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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