Penile Intracavernosal Stem Cells Therapy for Erectile Dysfunction

Phase 2

• Conditions: Erectile Dysfunction
• Interventions: Procedure: liposuction for retrieval of own stem cells from fat cells

• Registration Number: NCT02665520
• Lead Sponsor: Elaj medical centers

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-09
• Study Start: 2015-10
• Status Verified: 2016-01
• Study First Submitted QC: 2016-01-26
• Last Update Submitted: 2016-01-26
• Study First Posted: 2016-01-27
• Last Update Posted: 2016-01-27
• Primary Completion: 2017-03
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
stem cells injection in penis	liposuction for retrieval of own stem cells from fat cells	Treatment Injection of adipose derived cells into penis experimental;randomised

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

kING SAUD UNIVERSITY; 🇸🇦 Riyadh, Saudi Arabia

Elaj medical group; 🇸🇦 Jedda, Outside U.S./Canada, Saudi Arabia