Generation of an Induced Pluripotent Stem (iPS) Cell Bank Immune Matched to a Majority of the US Population

• Sponsor: Center for International Blood and Marrow Transplant Research (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03434808
• Collaborator: Cellular Dynamics International, Inc. - A FUJIFILM Company (Other)
• Enrollment: 19
• Actual Duration (Months): 19.1

Study Details

Study Description

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	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: N/A
• 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: Jan 13, 2017
• Actual Primary Completion Date: Aug 17, 2018
• Actual Study Completion Date: Aug 17, 2018

Outcome Measures

Primary Outcome Measures

1. Twelve whole blood samples donated for the manufacture and banking of iPS cells [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 61 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Center for International Blood and Marrow Transplant Research
• Cellular Dynamics International, Inc. - A FUJIFILM Company

Investigators

• Principal Investigator: Dennis Confer, MD, National Marrow Donor Program
• Principal Investigator: Amanda Mack, PhD, Cellular Dynamics International, Inc. - A FUJIFILM Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Center for International Blood and Marrow Transplant Research
• ClinicalTrials.gov Identifier: NCT03434808
• Other Study ID Numbers: 15-CDI
• First Posted: Feb 15, 2018
• Last Update Posted: Jul 15, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 15, 2020