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Generation of Haploid Stem Cells From Human Germ Cells

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2013 by Rambam Health Care Campus.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01454765
First Posted: October 19, 2011
Last Update Posted: December 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rambam Health Care Campus
  Purpose
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.

Condition Intervention
Induced Pluripotent Stem Cells Other: generation of stem cells

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Generation of Haploid Stem Cells From Human Germ Cells

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Patients donated samples [ Time Frame: June 2011-November 2013 ]
    No samples collected to date


Secondary Outcome Measures:
  • No secomdary outcome [ Time Frame: June 2011 - November 2013 ]

Biospecimen Retention:   Samples With DNA
Germ cells and Stem cells

Estimated Enrollment: 10
Study Start Date: December 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Sperm sample from healthy volunteers Other: generation of stem cells
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.
Other Name: generation of stem cells from somatic haploid germ cells

Detailed Description:
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 animal models. haploid cells are easier for genetic manipulations, such as knock-in and knock-out of genes, and therefore should make a better experimental model. The investigators aim at generating haploid stem cells from human haploid germ cells.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Male volunteers
Criteria

Inclusion Criteria:

  1. males over the age of 18 and under 50
  2. no known chronic illness
  3. not taking any chronic drugs

Exclusion Criteria:

  1. females
  2. males under 18 or over 50
  3. any known chronic illness
  4. taking chronic medications
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01454765


Locations
Israel
Rambam medical center Not yet recruiting
Haifa, Israel, 30196
Contact: Itay Maza, MD    050-206-2609    i_maza@rambam.health.gov.il   
Principal Investigator: Itay Maza, MD         
Weizmann institute of science Recruiting
Rehovot, Israel, 76100
Contact: Itay Maza, MD    +972-8-934-2230    itaym@weizmann.ac.il   
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Itay Maza, M.D Rambam Health Care Campus
  More Information

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01454765     History of Changes
Other Study ID Numbers: rmb-maza0001-ctil
First Submitted: October 16, 2011
First Posted: October 19, 2011
Last Update Posted: December 11, 2013
Last Verified: December 2013