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Trial record 2 of 107 for:    iPS cell

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
Sponsor:
Collaborator:
Cellular Dynamics International, Inc. - A FUJIFILM Company
Information provided by (Responsible Party):
Center for International Blood and Marrow Transplant Research

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 in the US population.

Condition or disease Intervention/treatment Phase
iPS Cell Manufacture and Banking Other: Whole Blood Donation Not Applicable

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 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Intervention Details:
  • Other: Whole Blood Donation
    Study subjects will provide 250ml whole blood donation for the manufacture and banking of iPS cells.


Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 61 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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
  2. Possess an HLA haplotype of interest to the Study
  3. Be at least 18 years of age and not past 61st birthday
  4. Meet the following criteria and requirements:

4.1 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 Criteria:

  1. Be unwilling or unable to give informed consent
  2. Be pregnant
  3. Have a prior history of: (i) a bone marrow transplant, or (ii) cancer of any type

Information from the National Library of Medicine

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


Sponsors and Collaborators
Center for International Blood and Marrow Transplant Research
Cellular Dynamics International, Inc. - A FUJIFILM Company
Investigators
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Principal Investigator: Dennis Confer, MD National Marrow Donor Program
Principal Investigator: Amanda Mack, PhD Cellular Dynamics International, Inc. - A FUJIFILM Company

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Responsible Party: Center for International Blood and Marrow Transplant Research
ClinicalTrials.gov Identifier: NCT03434808     History of Changes
Other Study ID Numbers: 15-CDI
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No