Penile Intracavernosal Stem Cells Therapy for Erectile Dy... | NCT02665520

Studies
Penile Intracavernosal Stem Cells Therapy for Erectile Dysfunction

NCT02665520

Sponsor

Elaj medical centers

Status

Unknown status

Last Update Posted

Jan 27, 2016Estimated

Enrollment

30Estimated

Phase

Phase 2

Conditions

Erectile Dysfunction

Interventions

liposuction for retrieval of own stem cells from fat cells

Countries

Saudi Arabia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Mar 2017Estimated

Completion Date

May 2017Estimated

First Submitted Date

Mar 9, 2015

First Submission Date that Met QC Criteria

Jan 26, 2016

First Posted Date

Jan 27, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2016

Last Update Posted Date

Jan 27, 2016Estimated

Name	Class
King Saud University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
liposuction for retrieval of own stem cells from fat cells	Procedure		stem cells injection in penis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
MOHAMAD HABOUS, M.D;FEBU	Contact	+966599950131		drmhabos@hotmail.com
Saleh Binsaleh, MD	Contact	+966502100034		surgon@hotmail.com

Overall Officials

Name	Affiliation	Role
Saleh Binsaleh, MD	King Saud University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Elaj medical group	Recruiting	Jeddah	Outside U.S./Canada	21463	Saudi Arabia

Condition Browse Module

MeSH Terms

ID	Term
D007172	Erectile Dysfunction

Ancestor Terms

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D012735	Sexual Dysfunction, Physiological

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015187	Lipectomy

Ancestor Terms

ID	Term
D003357	Cosmetic Techniques
D013812	Therapeutics
D050110	Bariatric Surgery
D049088	Bariatrics

Browse Leaves

Not provided

Browse Branches

Not provided