Penile Intracavernosal Stem Cells Therapy for Erectile Dysfunction

Erectile Dysfunction Clinical Trial

Official title:

Phase 1 Study of the Use of Autologous Penile Stem Cells in Men With Erectile Dysfunction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02665520
• Other study ID #: Elaj stem cells 1
• Status: Recruiting
• Phase: Phase 2
• First received: March 9, 2015
• Last updated: January 26, 2016
• Start date: October 2015
• Est. completion date: May 2017

Study information

• Verified date: January 2016
• Source: Elaj medical centers
• Contact: MOHAMAD HABOUS, M.D;FEBU
• Phone: +966599950131
• Email: drmhabos[@]hotmail.com
• Is FDA regulated: No
• Health authority: Saudi Arabia: Saudi Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Procedure:
• liposuction for retrieval of own stem cells from fat cells

Locations

Country	Name	City	State
Saudi Arabia	Elaj medical group	Jedda	Outside U.S./Canada
Saudi Arabia	kING SAUD UNIVERSITY	Riyadh

Sponsors (2)

Lead Sponsor	Collaborator
Elaj medical centers	King Saud University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events that occur during or after the procedure to measure safety and tolerability	to assess efficacy and safety of injection of stem autologous stem cells in penis of ED patients	1 year	Yes