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Generation of Haploid Stem Cells From Human Germ Cells

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ClinicalTrials.gov Identifier: NCT01454765
Recruitment Status : Unknown
Verified December 2013 by Rambam Health Care Campus.
Recruitment status was:  Recruiting
First Posted : October 19, 2011
Last Update Posted : December 11, 2013
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus

Tracking Information
First Submitted Date October 16, 2011
First Posted Date October 19, 2011
Last Update Posted Date December 11, 2013
Study Start Date December 2011
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 10, 2013)
Patients donated samples [ Time Frame: June 2011-November 2013 ]
No samples collected to date
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01454765 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 10, 2013)
No secomdary outcome [ Time Frame: June 2011 - November 2013 ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Generation of Haploid Stem Cells From Human Germ Cells
Official Title Generation of Haploid Stem Cells From Human Germ Cells
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.
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.
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Germ cells and Stem cells
Sampling Method Non-Probability Sample
Study Population Male volunteers
Condition Induced Pluripotent Stem Cells
Intervention 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
Study Groups/Cohorts Sperm sample from healthy volunteers
Intervention: Other: generation of stem cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: October 18, 2011)
10
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2015
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT01454765
Other Study ID Numbers rmb-maza0001-ctil
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Rambam Health Care Campus
Study Sponsor Rambam Health Care Campus
Collaborators Not Provided
Investigators
Principal Investigator: Itay Maza, M.D Rambam Health Care Campus
PRS Account Rambam Health Care Campus
Verification Date December 2013