Penile Intracavernosal Stem Cells Therapy for Erectile Dysfunction

January 26, 2016 updated by: Mohamad Habous, Elaj medical centers

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Riyadh, Saudi Arabia
        • Recruiting
        • King Saud University
        • Contact:
    • Outside U.S./Canada
      • Jedda, Outside U.S./Canada, Saudi Arabia, 21463
        • Recruiting
        • Elaj medical group
        • Contact:
        • Principal Investigator:
          • Saleh Binsaleh, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events that occur during or after the procedure to measure safety and tolerability
Time Frame: 1 year
to assess efficacy and safety of injection of stem autologous stem cells in penis of ED patients
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elaj medical centers

Collaborators

King Saud University

Investigators

  • Study Director: Saleh Binsaleh, MD, King Saud University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

March 9, 2015

First Submitted That Met QC Criteria

January 26, 2016

First Posted (Estimate)

January 27, 2016

Study Record Updates

Last Update Posted (Estimate)

January 27, 2016

Last Update Submitted That Met QC Criteria

January 26, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Elaj stem cells 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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