Generation of an Induced Pluripotent Stem (iPS) Cell Bank... | NCT03434808

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

NCT03434808

Sponsor

Center for International Blood and Marrow Transplant Research

Status

Terminated

Last Update Posted

Jul 15, 2020Actual

Enrollment

19Actual

Phase

Not Applicable

Conditions

iPS Cell Manufacture and Banking

Interventions

Whole Blood Donation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Slow accrual

Expanded Access Info

Start Date

Jan 13, 2017Actual

Primary Completion Date

Aug 17, 2018Actual

Completion Date

Aug 17, 2018Actual

First Submitted Date

Feb 9, 2018

First Submission Date that Met QC Criteria

Feb 9, 2018

First Posted Date

Feb 15, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 14, 2020

Last Update Posted Date

Jul 15, 2020Actual

Name	Class
Cellular Dynamics International, Inc. - A FUJIFILM Company	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Whole Blood Donation	Other	Study subjects will provide 250ml whole blood donation for the manufacture and banking of iPS cells.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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:

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:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

61 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided