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Use of Existing Fibroblast Cells to Convert to Induced Pluripotent Stem Cells

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00801372
First received: December 2, 2008
Last updated: September 1, 2016
Last verified: August 2016
  Purpose

Induced pluripotent stem cells potentially may be useful in the future as an unlimited source of cells for transplantation.

The major goal of the project is to develop human iPS cells from existing lines of fibroblasts that were originally donated as clinical grade feeders for the development of clinical grade hESCs. The clinical grade feeders were developed from aborted fetuses, foreskin and umbilical cord.


Condition
Pregnant, Healthy Females
Healthy Male Newborns

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Use of Existing Fibroblast Cells to Convert to Induced Pluripotent Stem Cells

Further study details as provided by Hadassah Medical Organization:

Estimated Enrollment: 1
Study Start Date: November 2008
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pre-existing Fibroblast MCB
Pre-existing fibroblast donors for hESC derivation project

Detailed Description:

The potential to reprogram somatic cells into an embryonic state raises multiple basic research questions related both to the process of reprogramming and the properties of iPS cells. We will use various approaches to study the molecular mechanisms and processes that occur during reprogramming. We will use various experimental systems to characterize and study the properties of the iPS cells, their biology, developmental potential, capability to give rise to functional differentiated progeny etc.

The clinical grade donated feeders used in this project were developed under GMP conditions using animal-free reagents. For potential future clinical applications, the iPS cells will be developed under GMP conditions, using reagents and methods that will be acceptable for clinical applications.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

pregnant, healthy females older than 18 who signed an informed consent for the termination of the pregnancy.

pregnant healthy couples older than 18 who signed an informed consent for a c-section.

healthy male newborns, undergoing surgical circumcision who's parents older than 18 signed an informed consent.

Criteria

Inclusion Criteria:

  • healthy, older than 18

Exclusion Criteria:

  • non healthy, younger than 18
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00801372

Contacts
Contact: Benjamin E Reubinoff, PhD MD 011-972-2-6774569 benjaminr@ekmd.huji.ac.il
Contact: Shelly E. Tannenbaum, MSQA 011-972-2-572-2000 stannenbaum@hadassah.org.il

Locations
Israel
Hadassah Ein Kerem Recruiting
Jerusalem, Israel, 9112100
Contact: Benjamin E Reubinoff, Professor    972-2-6776424/5    benr@hadassah.org.il   
Contact: Shelly E Tannenbaum, MSQA    972-2-6775700    stannenbaum@hadassah.org.il   
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

Publications:
Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00801372     History of Changes
Other Study ID Numbers: 0522-08- HMO-CTIL 
Study First Received: December 2, 2008
Last Updated: September 1, 2016
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
pregnant, healthy females older than 18 who signed an informed consent for the termination of the pregnancy.
pregnant healthy couples older than 18 who signed an informed consent for a c-section.
healthy male newborns, undergoing surgical circumcision who's parents older than 18 signed an informed consent.

ClinicalTrials.gov processed this record on September 29, 2016