Induced Pluripotent Stem CellsNCT01454765
Generation of Haploid Stem Cells From Human Germ Cells
An observational study of Induced Pluripotent Stem Cells, run by Rambam Health Care Campus at 2 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Induced Pluripotent Stem Cells
- What is being tested?
- generation of stem cells
- How many people
- 10 participants
- Where
- 2 sitesIsrael
- Study dates
- Dec 2011to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Male volunteers
Who may be able to join
- males over the age of 18 and under 50
- no known chronic illness
- not taking any chronic drugs
Who cannot join
- females
- males under 18 or over 50
- any known chronic illness
- taking chronic medications
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Not yet recruiting
Rambam medical center
Haifa, 30196
Itay Maza, MD, 050-206-2609, i_maza@rambam.health.gov.il
Itay Maza, MD
- Recruiting
Weizmann institute of science
Rehovot, 76100
Itay Maza, MD, +972-8-934-2230, itaym@weizmann.ac.il
About this study
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.
Read the 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.
- Conditions
- Induced Pluripotent Stem Cells
- Being tested
- generation of stem cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
generation of stem cellsOther
Also called generation of stem cells from somatic haploid germ 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.
| Study group | Role | What they receive |
|---|---|---|
| Sperm sample from healthy volunteers | Not described Receives: Other: generation of stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients donated samples
No samples collected to date
Measured: June 2011-November 2013
Secondary outcomes (1)
No secomdary outcome
Measured: June 2011 - November 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2014 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induced Pluripotent Stem CellsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Itay Maza, M.D, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01454765
- Sponsor's protocol ID
- rmb-maza0001-ctil
- Status last verified
- Dec 2013
- First submitted
- 16 Oct 2011
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generation of Haploid Stem Cells From Human Germ Cells
- ClinicalTrials.gov ID
- NCT01454765
- Acronym / sponsor ID
- rmb-maza0001-ctil
- Conditions
- Induced Pluripotent Stem Cells
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 19 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sperm sample from healthy volunteers | – | Other: generation of stem cells |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Male volunteers
Key inclusion criteria (3 listed)
- males over the age of 18 and under 50
- no known chronic illness
- not taking any chronic drugs
Key exclusion criteria (4 listed)
- females
- males under 18 or over 50
- any known chronic illness
- taking chronic medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| generation of stem cellsAlso: generation of stem cells from somatic haploid germ cellsCollected 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 | Sperm sample from healthy volunteers |
Primary outcome
Patients donated samples
Time frame: June 2011-November 2013
No samples collected to date
1 secondary outcome
No secomdary outcome
Time frame: June 2011 - November 2013
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Itay Maza, M.D principal investigator
Rambam Health Care Campus
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Induced Pluripotent Stem Cells, run by Rambam Health Care Campus at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients donated samples (time frame: June 2011-November 2013). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2013.