Status:
TERMINATED
Generation of an Induced Pluripotent Stem (iPS) Cell Bank Immune Matched to a Majority of the US Population
Lead Sponsor:
Center for International Blood and Marrow Transplant Research
Collaborating Sponsors:
Cellular Dynamics International, Inc. - A FUJIFILM Company
Conditions:
iPS Cell Manufacture and Banking
Eligibility:
All Genders
18-61 years
Phase:
NA
Brief Summary
The purpose of this study is to develop a collection of iPS cells called a bank ("Bank") that are immune-matched to a large percentage of the US population by containing the most common HLA haplotypes...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Be associated with an NMDP/Be The Match-operated donor center or non-operated donor center that has an IRB Authorization Agreement with the NMDP IRB and allows NMDP staff to directly contact their donors
- Possess an HLA haplotype of interest to the Study
- Be at least 18 years of age and not past 61st birthday
- Meet the following criteria and requirements:
- 1 Meet the donor requirements under 21 CFR 1271 and related August 2007 guidance 4.2 Body weight of at least 110 pounds 4.3 Complete and pass the abbreviated Health History Screening questionnaire 4.4 Complete and pass the full Health History questionnaire after donor enrollment 4.5 Non-reactive for any FDA-listed relevant communicable disease agent 4.6 Non-reactive for cytomegalovirus (CMV) 4.7 Express blood group O
Exclusion
- Be unwilling or unable to give informed consent
- Be pregnant
- Have a prior history of: (i) a bone marrow transplant, or (ii) cancer of any type
Key Trial Info
Start Date :
January 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 17 2018
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03434808
Start Date
January 13 2017
End Date
August 17 2018
Last Update
July 15 2020
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