Blood Collection From Healthy Volunteers and Patients for the Production of Clinical Grade Induced Pluripotent Stem Cell (iPSC) Products
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|ClinicalTrials.gov Identifier: NCT02056613|
Recruitment Status : Withdrawn
First Posted : February 6, 2014
Last Update Posted : November 5, 2018
- Pluripotent stem cells are cells that can be converted to any type of cell (muscle, nerve, liver, etc.). Researchers are collecting blood samples to develop way to make a special cell product called induced pluripotent stem cells (iPSCs). iPSCs may be used to repair or replace organs and tissues, produce blood and immune cells for transfusion, or correct inherited immune and blood diseases. iPSCs can be made from many kinds samples, such as skin, blood, or hair. This is different from embryonic stem cells, which can only be derived from embryos.
- To develop new methods to make iPSCs; to identify better ways to collect, produce, and grow them; and to make an iPSC bank.
- Healthy adults and adults already in a treatment protocol who have a medical condition that could be treated with iPSCs.
- All participants will be screened with questionnaire, physical exam, and blood and HIV tests.
- All participants:
- Will donate 4 tablespoons of blood. It will be taken by needle from a vein in their arm.
- Participants already in another protocol:
- Will have their blood collected, separated in a lab, and iPSCs grown in large numbers. Some may have their sample given back to them as a treatment.
- Samples will be kept in the study up to 5 years or until a participant withdraws from the study or becomes ineligible to participate, or the study is closed. If participants have not withdrawn their consent, they may be contacted in the future to donate again.
|Condition or disease|
|Induced Pluripotent Stem Cells|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Collection of Blood From Healthy Volunteers and Clinical Research Subjects for the Production of Clinical Grade Induced Pluripotent Stem Cell (iPSC) Products|
|Study Start Date :||February 5, 2014|
|Actual Primary Completion Date :||November 1, 2018|
|Actual Study Completion Date :||November 1, 2018|
- collection of blood samples for production of iPSCs or iPSV-derived therapy products [ Time Frame: Ongoing ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056613
|Principal Investigator:||David F Stroncek, M.D.||National Institutes of Health Clinical Center (CC)|