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Status unknownNCT02665520Updated Jan 27, 2016

Penile Intracavernosal Stem Cells Therapy for Erectile Dysfunction

A Phase 2 interventional study of liposuction for retrieval of own stem cells from fat cells in Erectile Dysfunction, sponsored by Elaj medical centers. Status unknown at 2 sites in Saudi Arabia. Open to male participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-01-27.

Sponsored by Elaj medical centers · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Erectile Dysfunction

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Keywords

  • stem cells injections
  • erectile dysfunction
03

In context

Erectile Dysfunction

683 studies on the registry are indexed under Erectile Dysfunction; 117 are open to participants now.

This study's planned enrollment of 30 is below the median of 72 across 542 interventional studies indexed under Erectile Dysfunction.

Browse Erectile Dysfunction studies →

Lead sponsor

This is the only study on the registry with Elaj medical centers as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Male 40 years old and older suffering from moderate to sever erectile dysfunction -

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    stem cells injection in penis

    Treatment Injection of adipose derived cells into penis experimental;randomised

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

  • No intervention
    controled arm

Interventions

  • Procedureliposuction for retrieval of own stem cells from fat cells
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 year

07

Study locations

2 of 2 sites recruiting
  • Elaj medical group
    Jedda, Outside U.S./Canada 21463, Saudi Arabia
    • Mohamad Habous · Contact · drmhabos@hotmail.com · +966599950131
    • Saleh Binsaleh, MD · Principal investigator
    Recruiting
  • kING SAUD UNIVERSITY
    Riyadh, Saudi Arabia
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02665520
Lead sponsor
Elaj medical centers
Collaborators
King Saud University
Responsible party
Mohamad Habous (Dr Mohamad Habous, Elaj medical centers) — Principal investigator
First posted
Jan 27, 2016
Start date
Oct 2015
Primary completion
Mar 2017 (estimated)
Completion
May 2017 (estimated)
Last update
Jan 27, 2016

Study contacts

MOHAMAD HABOUS, M.D;FEBU
Contact
drmhabos@hotmail.com
+966599950131
Saleh Binsaleh, MD
Contact
surgon@hotmail.com
+966502100034
Saleh Binsaleh, MD
study director · King Saud University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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