Normal Healthy EmbryosNCT01165918
Derivation of New Human Embryonic Stem Cell Lines: Identification of Instructive Factors for Germ Cells Development
An observational study of Normal Healthy Embryos, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is 1. To generate human embryonic stem cells lines (hESC) lines 2. Study of the factors that contribute to differentiation towards germ cell. Read more about this study
- Who is it for?
- Ages 2 to 4 daysHealthy volunteers can take part
- Conditions the study is for
- Normal Healthy Embryos
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2010to not given
- 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 2 to 4 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: any donated embryo
Who may be able to join
- any donated embryos
Who cannot join
- not relevant
Trial locations and contacts
1 site in 1 country.
Israel1 site
Soroka medical center
Beersheba, 84101
Rivka Ofir, PhD, 972 8 6477272, rivir@bgu.ac.il
Rivka Ofir, PhD
About this study
Official title: Basic Research. Unveiling Factors That Contribute to Germ Cell Differentiation
The purpose of this study is
- To generate human embryonic stem cells lines (hESC) lines
- Study of the factors that contribute to differentiation towards germ cell.
- Conditions
- Normal Healthy Embryos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Donated embryos | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
New hESC
Donated embryos will be used for derivation of the Es cells
Measured: 1 year
Secondary outcomes (1)
Factors that contribute to germ cells differentiation
We shall employ the knowledge from a study of sperm differentiation in mice to instruct the differentiation of ES cells towards germ cells
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2010 (estimated)
- Study startOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Healthy EmbryosStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ben-Gurion University of the Negev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01165918
- Sponsor's protocol ID
- Sor491210CTIL
- Status last verified
- Jun 2010
- First submitted
- 6 Jul 2010
- Last updated
- 20 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Basic Research. Unveiling Factors That Contribute to Germ Cell Differentiation
- ClinicalTrials.gov ID
- NCT01165918
- Acronym / sponsor ID
- Sor491210CTIL
- Conditions
- Normal Healthy Embryos
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Collaborators
- Ben-Gurion University of the Negev
- Study start
- Oct 2010
- First posted
- 20 Jul 2010 (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.
The purpose of this study is
- To generate human embryonic stem cells lines (hESC) lines
- Study of the factors that contribute to differentiation towards germ cell.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Donated embryos | – | – |
Who may qualify
- Ages
- 2 to 4 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- any donated embryo
Key inclusion criteria (1 listed)
- any donated embryos
Key exclusion criteria (1 listed)
- not relevant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
New hESC
Time frame: 1 year
Donated embryos will be used for derivation of the Es cells
1 secondary outcome
Factors that contribute to germ cells differentiation
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2010.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Normal Healthy Embryos, run by Soroka University Medical Center at 1 site 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 1 inclusion and 1 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 20 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Eitan Lunenfeld, MD and Prof. (- 972-8-6460058, lunenfld@bgumail.bgu.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New hESC (time frame: 1 year). 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 20 Jul 2010.