Clinical trial NCT03434808: Generation of an Induced Pluripotent Stem (iPS) Cell Bank Immune Matched to a Majority of the US Population
Official title: Generation of an Induced Pluripotent Stem (iPS) Cell Bank Immune Matched to a Majority of the US Population
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: iPS Cell Manufacture and Banking
Lead sponsor: Center for International Blood and Marrow Transplant Research
Sponsor class: NETWORK
Collaborators: name: Cellular Dynamics International, Inc. - A FUJIFILM Company
First posted: 2018-02-15
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 61
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Twelve whole blood samples donated for the manufacture and banking of iPS cells
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Marrow Donor Program
name: Dennis Confer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cellular Dynamics International, Inc. - A FUJIFILM Company
name: Amanda Mack, PhD
role: PRINCIPAL_INVESTIGATOR
References: