Penile Intracavernosal Stem Cells Therapy for Erectile Dysfunction

NCT ID: NCT02665520

Last Updated: 2016-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-05-31

Brief Summary

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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

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Conditions

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Erectile Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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stem cells injection in penis

Treatment Injection of adipose derived cells into penis experimental;randomised

Group Type ACTIVE_COMPARATOR

liposuction for retrieval of own stem cells from fat cells

Intervention Type PROCEDURE

controled arm

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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liposuction for retrieval of own stem cells from fat cells

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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King Saud University

OTHER

Sponsor Role collaborator

Elaj medical centers

OTHER

Sponsor Role lead

Responsible Party

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Mohamad Habous

Dr Mohamad Habous

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Saleh Binsaleh, MD

Role: STUDY_DIRECTOR

King Saud University

Locations

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Elaj medical group

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

Site Status RECRUITING

kING SAUD UNIVERSITY

Riyadh, , Saudi Arabia

Site Status RECRUITING

Countries

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Saudi Arabia

Central Contacts

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MOHAMAD HABOUS, M.D;FEBU

Role: CONTACT

+966599950131

Saleh Binsaleh, MD

Role: CONTACT

+966502100034

Facility Contacts

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Mohamad Habous

Role: primary

+966599950131

Saleh Binsaleh, MD

Role: primary

+966502100034

Other Identifiers

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Elaj stem cells 1

Identifier Type: -

Identifier Source: org_study_id

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