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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00953693
Other study ID # Royan-iPS-001
Secondary ID
Status Completed
Phase N/A
First received August 3, 2009
Last updated December 25, 2012
Start date April 2009
Est. completion date July 2010

Study information

Verified date April 2010
Source Royan Institute
Contact n/a
Is FDA regulated No
Health authority Iran: Ethics CommitteeIran: Ministry of Health
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date July 2010
Est. primary completion date January 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 12 Years to 80 Years
Eligibility 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:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Intervention

Procedure:
Biopsy
Skin biopsy

Locations

Country Name City State
Iran, Islamic Republic of Royan Institute Tehran

Sponsors (1)

Lead Sponsor Collaborator
Royan Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (1)

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 — View Citation

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