Generation of an Induced Pluripotent Stem (iPS) Cell Bank Immune Matched to a Majority of the US Population
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|ClinicalTrials.gov Identifier: NCT03434808|
Recruitment Status : Suspended (Slow accrual)
First Posted : February 15, 2018
Last Update Posted : July 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|iPS Cell Manufacture and Banking||Other: Whole Blood Donation||Not Applicable|
This study is being done to produce a bank of iPS cells that researchers from around the world can use for many different purposes. Some examples of such uses include basic research, discovery of new medicines, developing new products and services useful for studying human disease, and developing new cell-based products useful for treating people that have diseases. The idea of using cells made from human iPS cells to treat human diseases is of great interest in medicine. In this bank, a single donor's cells could be used to treat many people.
The iPS cells that are made as part of this study will be included in a bank owned by CDI. The iPS cells and the cells made from them will be available for laboratory research or for clinical use in patients. It is possible that the iPS cells made from the blood donated and cells made from the iPS cells could be beneficial to many different patients and be used for many different research projects to understand human biology and disease.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Generation of an Induced Pluripotent Stem (iPS) Cell Bank Immune Matched to a Majority of the US Population|
|Actual Study Start Date :||January 13, 2017|
|Estimated Primary Completion Date :||January 1, 2020|
|Estimated Study Completion Date :||January 1, 2020|
- Other: Whole Blood Donation
Study subjects will provide 250ml whole blood donation for the manufacture and banking of iPS cells.
- Twelve whole blood samples donated for the manufacture and banking of iPS cells [ Time Frame: 2 years ]The objective will have been met when donor blood samples have been collected from eligible donors possessing homozygous HLA haplotypes of interest providing a beneficial match to at least 95 percent of the US population as determined by the matching algorithm used in this study.
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): NCT03434808
|Principal Investigator:||Dennis Confer, MD||National Marrow Donor Program|
|Principal Investigator:||Amanda Mack, PhD||Cellular Dynamics International, Inc. - A FUJIFILM Company|