Derivation of New Human Embryonic Stem Cell Lines: Identi... | NCT01165918

Studies
Derivation of New Human Embryonic Stem Cell Lines: Identification of Instructive Factors for Germ Cells Development

NCT01165918

Sponsor

Soroka University Medical Center

Status

Unknown status

Last Update Posted

Jul 20, 2010Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Normal Healthy Embryos

Interventions

Not provided

Countries

Israel

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

Jun 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jul 6, 2010

First Submission Date that Met QC Criteria

Jul 18, 2010

First Posted Date

Jul 20, 2010Estimated

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

Jul 18, 2010

Last Update Posted Date

Jul 20, 2010Estimated

Name	Class
Ben-Gurion University of the Negev	OTHER

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

The purpose of this study is

To generate human embryonic stem cells lines (hESC) lines
Study of the factors that contribute to differentiation towards germ cell.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Label	Type	Description	Intervention Names
Donated embryos

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
New hESC	Donated embryos will be used for derivation of the Es cells	1 year

Secondary Outcomes

Measure	Description	Time Frame
Factors that contribute to germ cells differentiation	We shall employ the knowledge from a study of sperm differentiation in mice to instruct the differentiation of ES cells towards germ cells	4 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

any donated embryos

Exclusion Criteria:

not relevant

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Days

Maximum Age

4 Days

Standard Ages

Child

Study Population

any donated embryo

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eitan Lunenfeld, MD and Prof.	Contact	- 972-8-6460058		lunenfld@bgumail.bgu.ac.il
Rivka Ofir	Contact	97286477272		rivir@bgu.ac.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Soroka medical center		Beersheba		84101	Israel