NCT03434808

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 15, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2018

Completed
Last Updated

July 15, 2020

Status Verified

July 1, 2020

Enrollment Period

1.6 years

First QC Date

February 9, 2018

Last Update Submit

July 14, 2020

Conditions

iPS Cell Manufacture and Banking

Outcome Measures

Primary Outcomes (1)

  • Twelve whole blood samples donated for the manufacture and banking of iPS cells

    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.

    2 years

Interventions

Whole Blood DonationOTHER

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

Eligibility Criteria

Age18 Years - 61 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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:
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Dennis Confer, MD

    National Marrow Donor Program

    PRINCIPAL INVESTIGATOR

  • Amanda Mack, PhD

    Cellular Dynamics International, Inc. - A FUJIFILM Company

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2018

First Posted

February 15, 2018

Study Start

January 13, 2017

Primary Completion

August 17, 2018

Study Completion

August 17, 2018

Last Updated

July 15, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share