Intra Testicular Artery Injection of Bone Marrow Stem Cel... | NCT02008799

Studies
Intra Testicular Artery Injection of Bone Marrow Stem Cell in Management of Azoospermia

NCT02008799

Sponsor

Man Clinic for Andrology, Male Infertility and Sexual Dysfunction

Status

Unknown status

Last Update Posted

Apr 8, 2015Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Azoospermia

Interventions

Bone marrow stem cell injection

Countries

Egypt

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

Apr 2015

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

Jan 2013

Primary Completion Date

Mar 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Dec 8, 2013

First Submission Date that Met QC Criteria

Dec 8, 2013

First Posted Date

Dec 11, 2013Estimated

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

Apr 7, 2015

Last Update Posted Date

Apr 8, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Khaled Abdulmoneim Gadalla, Prof Dr, Man Clinic for Andrology, Male Infertility and Sexual DysfunctionPrincipal Investigator

Lead Sponsor

Man Clinic for Andrology, Male Infertility and Sexual DysfunctionOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

Azoospermia due to low sperm production (non-obstructive azoospermia) affects approximately 1% of the male population and 10% of men who seek fertility evaluation. Testis biopsy reveals that these men have Sertoli cell-only pattern, maturation arrest, or hypospermatogenesis. Until recently, it was assumed that men with non-obstructive azoospermia were untreatable. Indeed, these patients were often referred to as being "sterile" or having "testicular failure." We start to use stem cell in treatment of such patients by injecting the stem cell at the testis and the testicular artery in one group and at the testis only in other group

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bone marrow stem cell injection	Experimental	through special butterfly inject stem cell in testicular artery and inside tubules	Procedure: Bone marrow stem cell injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bone marrow stem cell injection	Procedure	Injection should be in testis and testicular artery	Bone marrow stem cell injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Semen Analysis	After stem cell injection by three to six months we evaluate the outcome by semen analysis	Three to six months

Secondary Outcomes

Measure	Description	Time Frame
Inhibin B Hormone	If semen analysis still azoo we do Inhibin B Hormone	Three to six months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Azoospermia

Exclusion Criteria:

- Absent or surgical removed testes

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Khaled A Gadalla, MD	Contact	20222725025		Khaledgadalla@gmail.com

Overall Officials

Name	Affiliation	Role
Khaled A Gadalla, MD	Man Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Man Clinic	Recruiting	Cairo		33611	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D053713	Azoospermia
D007246	Infertility

Ancestor Terms

ID	Term
D007248	Infertility, Male
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided