Erectile Dysfunction
Conditions
Keywords
stem cells injections, erectile dysfunction
Brief summary
Autologous Fat Derived Stem Cell treatment of ED. To assess safety and primary efficacy of stem cell infusion in refractory ED. To investigate the success rate and durability of success of using this new therapy in management of moderate and sever cases of erectile dysfunction.
Interventions
PROCEDUREliposuction for retrieval of own stem cells from fat cells
Sponsors
King Saud University
Elaj medical centers
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Male 40 years old and older suffering from moderate to sever erectile dysfunction -
Exclusion criteria
* Inability to give informed consent or attend follow up * Severe diabetic neuropathy (to be defined ? Charcot joints, diabetic ulcers?) or other neuropathic disease * Viral disease from infectivity viewpoint * Major penile fibrosis or severe Peyronie's disease * Severe primary large vessel ED (defined as PSV less than 15cm/s after ICI) * Severe primary venous leakage ED (defined as EDV more than 10cm/s after ICI) * Prior systemic chemotherapy, or radiotherapy to donor or recipient area * Not in potentially active sexual relationship * Age less than 40 or over 70
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events that occur during or after the procedure to measure safety and tolerability | 1 year | to assess efficacy and safety of injection of stem autologous stem cells in penis of ED patients |
Countries
Saudi Arabia
Contacts
Primary ContactMOHAMAD HABOUS, M.D;FEBU
Backup ContactSaleh Binsaleh, MD
Outcome results
None listed