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Patient Specific Induced Pluripotency Stem Cells (PSiPS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Royan Institute
ClinicalTrials.gov Identifier:
NCT00953693
First received: August 3, 2009
Last updated: December 25, 2012
Last verified: April 2010
History of Changes
  Purpose

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.


Condition Intervention
Hepatic Disorders
Eye Disorders
 Procedure: Biopsy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Patient Specific Induced Pluripotency Stem Cells (PSiPS)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Royan Institute:

Estimated Enrollment: 15
Study Start Date: April 2009
Study Completion Date: July 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Biopsy
    Skin biopsy
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.

  Eligibility

Ages Eligible for Study:   12 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The patient who suffering from metabolic disorders

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00953693

Locations
Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
Investigators
Study Chair: Hamid Gourabi, PhD Royan Institute
Study Director: Hossein Baharvand, PhD Royan Institute
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT00953693     History of Changes
Other Study ID Numbers: Royan-iPS-001
Study First Received: August 3, 2009
Last Updated: December 25, 2012
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

Keywords provided by Royan Institute:
Induced pluripotent stem cells
Hepatic disorders
Eye disorders
Blood groups

Additional relevant MeSH terms:
Eye Diseases
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 18, 2013