NCT02945462

Bone Marrow Mesenchymal Stem Cells in Erectile Dysfunction (ED)

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: University of Jordan · Academic / Other
• Sex: Male
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
BIOLOGICAL	autologous mesenchymal stem cells	Patients will be injected with autologous mesenchymal stem cells, intracavernously

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-11-01
• Completion: 2016-10-01
• First posted: 2016-10-26
• Last updated: 2016-11-16