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Blood Collection From Healthy Volunteers and Patients for the Production of Clinical Grade Induced Pluripotent Stem Cell (iPSC) Products

NCT02056613 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2018-11-05

No results posted yet for this study

Summary

Background:

\- 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.

Objectives:

\- To develop new methods to make iPSCs; to identify better ways to collect, produce, and grow them; and to make an iPSC bank.

Eligibility:

\- Healthy adults and adults already in a treatment protocol who have a medical condition that could be treated with iPSCs.

Design:

* 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 If participants have not withdrawn their consent, they may be contacted in the future to donate again.

Conditions

  • Induced Pluripotent Stem Cells

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • David F Stroncek, M.D. · National Institutes of Health Clinical Center (CC)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-02-05
Primary Completion
2018-11-01
Completion
2018-11-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02056613 on ClinicalTrials.gov