NCT01454765

Brief Summary

Human cells are diploid (contain a double set of chromosomes). The diploid genome is complex and therefore limits genetic research approaches in biomedical models. To overcome this problem experimental generation of haploid stem cells has been done in animals. The investigators aim at generating haploid stem cells from human germ cells that are a useful tool in genetic research and screening.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2011

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 19, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

December 11, 2013

Status Verified

December 1, 2013

Enrollment Period

3 years

First QC Date

October 16, 2011

Last Update Submit

December 10, 2013

Conditions

Induced Pluripotent Stem Cells

Outcome Measures

Primary Outcomes (1)

  • Patients donated samples

    No samples collected to date

    June 2011-November 2013

Secondary Outcomes (1)

  • No secomdary outcome

    June 2011 - November 2013

Study Arms (1)

Sperm sample from healthy volunteers

Other: generation of stem cells

Interventions

generation of stem cellsOTHER

Collected germ cells will be cultured in medium. The germ cell cultures will be infected with reprograming factors. Rare colonies with characteristic stem cell morphologies will be expanded.

Also known as: generation of stem cells from somatic haploid germ cells
Sperm sample from healthy volunteers

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Male volunteers

You may qualify if:

  • males over the age of 18 and under 50
  • no known chronic illness
  • not taking any chronic drugs

You may not qualify if:

  • females
  • males under 18 or over 50
  • any known chronic illness
  • taking chronic medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rambam medical center

Haifa, 30196, Israel

NOT YET RECRUITING

Weizmann institute of science

Rehovot, 76100, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Germ cells and Stem cells

Study Officials

  • Itay Maza, M.D

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2011

First Posted

October 19, 2011

Study Start

December 1, 2011

Primary Completion

December 1, 2014

Study Completion

August 1, 2015

Last Updated

December 11, 2013

Record last verified: 2013-12

Locations

IL(2)