Generation of Haploid Stem Cells From Human Germ Cells

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Rambam Health Care Campus
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01454765
First received: October 16, 2011
Last updated: December 10, 2013
Last verified: December 2013
  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 ] [ Designated as safety issue: No ]
    No samples collected to date


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

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

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01454765     History of Changes
Other Study ID Numbers: rmb-maza0001-ctil
Study First Received: October 16, 2011
Last Updated: December 10, 2013
Health Authority: Israel: Ethics Commission

ClinicalTrials.gov processed this record on August 21, 2014