Pregnant, Healthy FemalesNCT00801372
Use of Existing Fibroblast Cells to Convert to Induced Pluripotent Stem Cells
An observational study of Pregnant, Healthy Females and Healthy Male Newborns, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Induced pluripotent stem cells potentially may be useful in the future as an unlimited source of cells for transplantation. The major goal of the project is to develop human iPS cells from existing lines of fibroblasts that were originally donated as clinical grade feeders for the development of clinical grade hESCs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pregnant, Healthy Females, Healthy Male Newborns
- How many people
- 1 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2008to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: pregnant, healthy females older than 18 who signed an informed consent for the termination of the pregnancy. pregnant healthy couples older than 18 who signed an informed consent for a c-section. healthy male newborns, undergoing surgical circumcision who's parents older than 18 signed an informed consent.
Who may be able to join
- healthy, older than 18
Who cannot join
- non healthy, younger than 18
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Ein Kerem
Jerusalem, Israel, 9112100
Benjamin E Reubinoff, Professor, 972-2-6776424/5, benr@hadassah.org.il
Shelly E Tannenbaum, MSQA, 972-2-6775700, stannenbaum@hadassah.org.il
About this study
Induced pluripotent stem cells potentially may be useful in the future as an unlimited source of cells for transplantation.
The major goal of the project is to develop human iPS cells from existing lines of fibroblasts that were originally donated as clinical grade feeders for the development of clinical grade hESCs. The clinical grade feeders were developed from aborted fetuses, foreskin and umbilical cord.
Read the detailed description
The potential to reprogram somatic cells into an embryonic state raises multiple basic research questions related both to the process of reprogramming and the properties of iPS cells. We will use various approaches to study the molecular mechanisms and processes that occur during reprogramming. We will use various experimental systems to characterize and study the properties of the iPS cells, their biology, developmental potential, capability to give rise to functional differentiated progeny etc.
The clinical grade donated feeders used in this project were developed under GMP conditions using animal-free reagents. For potential future clinical applications, the iPS cells will be developed under GMP conditions, using reagents and methods that will be acceptable for clinical applications.
- Conditions
- Pregnant, Healthy Females, Healthy Male Newborns
- Keywords
- termination of pregnancy, surgical circumcision, umbilical cord
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 |
|---|---|---|
| Pre-existing Fibroblast MCB | Pre-existing fibroblast donors for hESC derivation project |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnant, Healthy FemalesStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin E Reubinoff, MD PhD, Principal investigator, Chairman of Department of Obstetrics & Gynecology/IVF, Hadassah Ein Kerem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801372
- Sponsor's protocol ID
- 0522-08- HMO-CTIL
- Status last verified
- Mar 2025
- First submitted
- 2 Dec 2008
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Takahashi K, Tanabe K, Ohnuki M, Narita M, Ichisaka T, Tomoda K, Yamanaka S. Induction of pluripotent stem cells from adult human fibroblasts by defined factors. Cell. 2007 Nov 30;131(5):861-72. doi: 10.1016/j.cell.2007.11.019.
PubMed 18035408
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Existing Fibroblast Cells to Convert to Induced Pluripotent Stem Cells
- ClinicalTrials.gov ID
- NCT00801372
- Acronym / sponsor ID
- 0522-08- HMO-CTIL
- Conditions
- Pregnant, Healthy Females, Healthy Male Newborns
- Keywords
- termination of pregnancy, surgical circumcision, umbilical cord
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Nov 2008 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 3 Dec 2008 (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.
Induced pluripotent stem cells potentially may be useful in the future as an unlimited source of cells for transplantation.
The major goal of the project is to develop human iPS cells from existing lines of fibroblasts that were originally donated as clinical grade feeders for the development of clinical grade hESCs. The clinical grade feeders were developed from aborted fetuses, foreskin and umbilical cord.
Detailed description
The potential to reprogram somatic cells into an embryonic state raises multiple basic research questions related both to the process of reprogramming and the properties of iPS cells. We will use various approaches to study the molecular mechanisms and processes that occur during reprogramming. We will use various experimental systems to characterize and study the properties of the iPS cells, their biology, developmental potential, capability to give rise to functional differentiated progeny etc.
The clinical grade donated feeders used in this project were developed under GMP conditions using animal-free reagents. For potential future clinical applications, the iPS cells will be developed under GMP conditions, using reagents and methods that will be acceptable for clinical applications.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre-existing Fibroblast MCB | – | –Pre-existing fibroblast donors for hESC derivation project |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- pregnant, healthy females older than 18 who signed an informed consent for the termination of the pregnancy. pregnant healthy couples older than 18 who signed an informed consent for a c-section. healthy male newborns, undergoing surgical circumcision who's parents older than 18 signed an informed consent.
Key inclusion criteria (1 listed)
- healthy, older than 18
Key exclusion criteria (1 listed)
- non healthy, younger than 18
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
Not reported in the source record.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Background: PubMed 18035408Takahashi K, Tanabe K, Ohnuki M, Narita M, Ichisaka T, Tomoda K, Yamanaka S. Induction of pluripotent stem cells from adult human fibroblasts by defined factors. Cell. 2007 Nov 30;131(5):861-72. doi: 10.1016/j.cell.2007.11.019.
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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.
Benjamin E Reubinoff, MD PhD principal investigator
Chairman of Department of Obstetrics & Gynecology/IVF, Hadassah Ein Kerem
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 Pregnant, Healthy Females and Healthy Male Newborns, run by Hadassah Medical Organization 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: looking for participants now, as of the sponsor's last update on 19 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin E Reubinoff, MD PhD (011-972-2-6774569, benjaminr@ekmd.huji.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00801372, which also lists 1 linked publication.
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 19 Mar 2025.