Metabolic DiseasesNCT00628199
Study to Create Potential Cell-Based Therapies to Treat Human Disease and Disability
An observational study of Metabolic Diseases and Infertility, run by Stanford University at 1 site in United States.
Trial summary
This is a research study in which your cells will be used for somatic cell nuclear transfer (SCNT), and/or genetic reprogramming research which may result in the production of stem cell lines. This study does not provide treatment. Read more about this study
- Who is it for?
- Ages 1 year to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Diseases, Infertility
- What is being tested?
- Improving the scientific process of human cell reprogramming
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Jan 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 1 year to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with specific disease or infertility with potential for stem cell therapy
Inclusion Criteria:1. Donors with a degenerative disease phenotype or genetic disorders such as Type I Diabetes, heart disease, or infertility (azoospermia and premature ovarian failure)
Exclusion Criteria:1. Unable to read or understand English. 2. Unable to provide skin biopsy sample due to skin condition in the underarm area.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Derivation of Primary Donor Cell Lines for Human Cell Reprogramming
This is a research study in which your cells will be used for somatic cell nuclear transfer (SCNT), and/or genetic reprogramming research which may result in the production of stem cell lines. This study does not provide treatment.
Read the detailed description
It is thought that studies of genetic reprogramming and SCNT using human cells have the potential to give us new basic knowledge about human development. Current work will focus on developing this basic knowledge. In the future, human embryonic stem cell lines (hESC) derived from genetic reprogramming and SCNT may also have the potential to develop into cell types that are useful for cell-based therapies to treat human disease and disability.
- Conditions
- Metabolic Diseases, Infertility
- Being tested
- Improving the scientific process of human cell reprogramming
- Medical subject headings
- Metabolic Diseases, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improving the scientific process of human cell reprogrammingProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2008 (estimated)
- Study startSep 2007
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DiseasesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marius Wernig, Stanford University
- Investigators
- Marius Wernig, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00628199
- Sponsor's protocol ID
- SU-12202007-950
- Other IDs
- NCT00553826
- Status last verified
- Aug 2022
- First submitted
- 22 Feb 2008
- Last updated
- 12 Aug 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Derivation of Primary Donor Cell Lines for Human Cell Reprogramming
- ClinicalTrials.gov ID
- NCT00628199
- Acronym / sponsor ID
- SU-12202007-950
- Conditions
- Metabolic Diseases, Infertility
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Sep 2007 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 4 Mar 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.
This is a research study in which your cells will be used for somatic cell nuclear transfer (SCNT), and/or genetic reprogramming research which may result in the production of stem cell lines. This study does not provide treatment.
Detailed description
It is thought that studies of genetic reprogramming and SCNT using human cells have the potential to give us new basic knowledge about human development. Current work will focus on developing this basic knowledge. In the future, human embryonic stem cell lines (hESC) derived from genetic reprogramming and SCNT may also have the potential to develop into cell types that are useful for cell-based therapies to treat human disease and disability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with specific disease or infertility with potential for stem cell therapy
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 |
|---|---|---|
| Improving the scientific process of human cell reprogramming | Procedure or surgery | – |
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 12 Aug 2022.
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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.
Marius Wernig, MD principal investigator
Stanford University
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 Metabolic Diseases and Infertility, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: enrolling by invitation, as of the sponsor's last update on 12 Aug 2022. 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 United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 12 Aug 2022.