- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00953693
Patient Specific Induced Pluripotency Stem Cells (PSiPS)
December 25, 2012 updated by: Royan Institute
Induced pluripotent stem cells (iPSCs) are adult cells that have been genetically reprogrammed to an embryonic stem cell-like state by being forced to express genes and factors important for maintaining the defining properties of embryonic stem cells.
The reprogramming of adult cells into embryonic stem (ES) cells enables the generation of patient-specific stem cells and thus has enormous potential for the treatment and analysis of degenerative diseases.
In this project the investigators are going to induce pluripotent stem cells from cell cultures from skin biopsies of patients.
The iPS cells will be developed for modeling diseases and drug discovery as well as basic research.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
iPS cells are typically derived by transfection of certain stem cell-associated genes into non-pluripotent cells, such as adult fibroblasts.
Transfection is typically achieved through viral vectors, such as retroviruses.
Transfected genes include the master transcriptional regulators Oct-3/4 (Pouf51) and Sox2, although to enhance the efficiency of induction some other genes e.g.
Klf4, c-Myc.
In this study after separation the fibroblasts from patient's skin biopsy, the cells are transfected with 4 Yamanaka factors (human Oct4, Sox2, Klf4, c-Myc) after 3-4 weeks, transfected cells are isolated through morphological selection.
Study Type
Observational
Enrollment (Anticipated)
15
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tehran, Iran, Islamic Republic of
- Royan Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 80 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The patient who suffering from metabolic disorders
Description
Inclusion Criteria:
- Donors suffering from different (specified) metabolic disorders
- Donors suffering from different (specified) eye disorders which resulted to blindness
- Special blood group: O Bombay
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Hossein Baharvand, PhD, Royan Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
January 1, 2010
Study Completion (Actual)
July 1, 2010
Study Registration Dates
First Submitted
August 3, 2009
First Submitted That Met QC Criteria
August 5, 2009
First Posted (Estimate)
August 6, 2009
Study Record Updates
Last Update Posted (Estimate)
December 27, 2012
Last Update Submitted That Met QC Criteria
December 25, 2012
Last Verified
April 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Royan-iPS-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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