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

NCT ID: NCT03434808

Last Updated: 2020-07-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-13
• Study Completion Date: 2018-08-17

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.

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.

Conditions

iPS Cell Manufacture and Banking

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Interventions

Whole Blood Donation

Study subjects will provide 250ml whole blood donation for the manufacture and banking of iPS cells.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 61 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cellular Dynamics International, Inc. - A FUJIFILM Company

UNKNOWN

Sponsor Role: collaborator

Center for International Blood and Marrow Transplant Research

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dennis Confer, MD

Role: PRINCIPAL_INVESTIGATOR

National Marrow Donor Program

Amanda Mack, PhD

Role: PRINCIPAL_INVESTIGATOR

Cellular Dynamics International, Inc. - A FUJIFILM Company

Other Identifiers

15-CDI

Identifier Type: -

Identifier Source: org_study_id