Patient Specific Induced Pluripotency Stem Cells (PSiPS)
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| First Received Date ICMJE | August 3, 2009 | ||||||||
| Last Updated Date | December 25, 2012 | ||||||||
| Start Date ICMJE | April 2009 | ||||||||
| Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00953693 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Patient Specific Induced Pluripotency Stem Cells (PSiPS) | ||||||||
| Official Title ICMJE | Patient Specific Induced Pluripotency Stem Cells (PSiPS) | ||||||||
| Brief Summary | 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | The patient who suffering from metabolic disorders |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: Biopsy
Skin biopsy |
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| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Seifinejad A, Taei A, Totonchi M, Vazirinasab H, Hassani SN, Aghdami N, Shahbazi E, Yazdi RS, Salekdeh GH, Baharvand H. Generation of human induced pluripotent stem cells from a Bombay individual: moving towards "universal-donor" red blood cells. Biochem Biophys Res Commun. 2010 Jan 1;391(1):329-34. Epub 2009 Nov 11. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Estimated Enrollment ICMJE | 15 | ||||||||
| Completion Date | July 2010 | ||||||||
| Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 12 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Iran, Islamic Republic of | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00953693 | ||||||||
| Other Study ID Numbers ICMJE | Royan-iPS-001 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Royan Institute | ||||||||
| Study Sponsor ICMJE | Royan Institute | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Royan Institute | ||||||||
| Verification Date | April 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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