Penile Intracavernosal Stem Cells Therapy for Erectile Dysfunction

NCT02665520 | Unknown Phase 2 DMC

• 1 other identifier: Elaj stem cells 1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Erectile Dysfunction

Keywords

stem cells injections; erectile dysfunction

Outcome Measures

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

  1 year

Study Arms (2)

stem cells injection in penis

ACTIVE COMPARATOR

Treatment Injection of adipose derived cells into penis experimental;randomised

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

controled arm

NO INTERVENTION

Interventions

liposuction for retrieval of own stem cells from fat cells PROCEDURE

stem cells injection in penis

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Elaj medical centers: lead
• King Saud University: collaborator

Study Sites (2)

Elaj medical group

Jeddah, Outside U.S./Canada, 21463, Saudi Arabia

RECRUITING

kING SAUD UNIVERSITY

Riyadh, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Lipectomy

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Bariatric Surgery; Bariatrics; Obesity Management; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Saleh Binsaleh, MD

  King Saud University

  STUDY DIRECTOR

Central Study Contacts

MOHAMAD HABOUS, M.D;FEBU

CONTACT

+966599950131; drmhabos@hotmail.com

Saleh Binsaleh, MD

CONTACT

+966502100034; surgon@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Mohamad Habous

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: January 27, 2016
• Study Start: October 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: May 1, 2017
• Last Updated: January 27, 2016

Record last verified: 2016-01

Locations

SA (2)