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Blood Collection From Healthy Volunteers and Patients for the Production of Clinical Grade Induced Pluripotent Stem Cell (iPSC) Products

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02056613
Recruitment Status : Withdrawn
First Posted : February 6, 2014
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)

Brief Summary:

Background:

- Pluripotent stem cells are cells that can be converted to any type of cell (muscle, nerve, liver, etc.). Researchers are collecting blood samples to develop way to make a special cell product called induced pluripotent stem cells (iPSCs). iPSCs may be used to repair or replace organs and tissues, produce blood and immune cells for transfusion, or correct inherited immune and blood diseases. iPSCs can be made from many kinds samples, such as skin, blood, or hair. This is different from embryonic stem cells, which can only be derived from embryos.

Objectives:

- To develop new methods to make iPSCs; to identify better ways to collect, produce, and grow them; and to make an iPSC bank.

Eligibility:

- Healthy adults and adults already in a treatment protocol who have a medical condition that could be treated with iPSCs.

Design:

  • All participants will be screened with questionnaire, physical exam, and blood and HIV tests.
  • All participants:
  • Will donate 4 tablespoons of blood. It will be taken by needle from a vein in their arm.
  • Participants already in another protocol:
  • Will have their blood collected, separated in a lab, and iPSCs grown in large numbers. Some may have their sample given back to them as a treatment.
  • Samples will be kept in the study up to 5 years or until a participant withdraws from the study or becomes ineligible to participate, or the study is closed. If participants have not withdrawn their consent, they may be contacted in the future to donate again.

Condition or disease
Induced Pluripotent Stem Cells

Detailed Description:
Induced pluripotent stem cells (iPSCs) can be produced from small quantities of blood. Clinical protocols to treat several diseases using iPSCs or cells derived from iPSCs are being developed by intramural investigators, i.e., investigators in National Institute of Allergy and Infectious Diseases (NIAID) and National Eye Institute (NEI). This clinical protocol will allow personnel in the Cell Processing Service (CPS) of the Department of Transfusion Medicine (DTM) to collect blood from healthy donors or patients with diseases targeted in IRB-approved treatment protocols to manufacture iPSCs or iPSC derived products to support these intramural investigators. CPS DTM will submit a Drug Master File (DMF) to the US Food and Drug Administration (FDA) for the manufacture and testing of these products. When iPSCs are used clinically in some cases the donors will be the recipients of the iPSCs, or the ex vivo expanded and differentiated iPSCs (autologous therapy). In other cases, healthy subjects will serve as donors of the blood used as starting material for manufacturing iPSCs (allogeneic therapy) where no matching of HLA or other antigens is required between the healthy blood donor and the iPSC recipient. While methods to produce and expand iPSCs have been described, they must be modified periodically to meet changing Good Manufacturing Practices (GMP) requirements for manufacturing clinical cell and gene therapies, therefore peripheral blood for iPSCs from normal donors is needed for research and development.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Collection of Blood From Healthy Volunteers and Clinical Research Subjects for the Production of Clinical Grade Induced Pluripotent Stem Cell (iPSC) Products
Study Start Date : February 5, 2014
Actual Primary Completion Date : November 1, 2018
Actual Study Completion Date : November 1, 2018



Primary Outcome Measures :
  1. collection of blood samples for production of iPSCs or iPSV-derived therapy products [ Time Frame: Ongoing ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA RELATED OR THIRD PARTY DONORS (ALLOGENEIC CELLS, INCLUDING RESEARCH DONORS) AND AUTOLOGOUS DONORS

Subjects who meet ALL of the following criteria will be considered for enrollment into this study:

  1. Be greater than or equal to 18 years of age, as of the date of enrollment. There is no upper age limit for donor enrollment.
  2. Able to provide informed consent.
  3. Meets the donation requirements established by AABB and FDA for allogeneic or autologous use with the exception of hemoglobin/hematocrit.

SUBJECT EXCLUSION CRITERIA ALLOGENEIC DONORS

Subjects who meet ANY of the following criteria will be excluded from participation in this study as a third party donor or research volunteer:

  1. Medical history that includes any of the following, as per AABB or FDA requirements for allogeneic use:

    • Thrombocytopenia or other blood dyscrasias
    • Bleeding diathesis
    • Antibiotic use within the prior 48 hours
    • History of cancer
    • History of exposure to transfusion transmitted diseases including HIV and hepatitis B and C as defined by the Standards for Blood Banking and Transfusion Services, AABB.
    • Travel to an area where malaria is endemic as defined by the CDC (www.cdc.gov/travel).
    • At risk for the possible transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) as described in the FDA Guidance for Industry, January 9, 2002, Revised Preventive Measures to Reduce the Possible Risk of Transfusion of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products
  2. Febr le (temperature >38 (Infinite)C)
  3. Hemoglobin level

    • African American women <11.5 grams/dL
    • Other women <12.0 grams/dL
    • Men <12.5 grams/dL
  4. HCT

    • African American women <34%
    • Other women <36%
    • Men <38%
  5. Platelets <150 times 103/microL
  6. Absolute neutrophil count <1.0 times 103/microL
  7. Positive tests for blood borne pathogens (as required by the Standards for Blood Banks and Transfusion Services, AABB. The currently required tests include anti-HIV1/2, anti-HCV, anti-HBc, Anti-HTLV I/II, anti-T. Cruzi, HBsAg, syphilis, and molecular testing for West Nile virus, HCV, HBV, and HIV-1).

SUBJECT EXCLUSION CRITERIA AUTOLOGOUS DONORS

Subjects who meet ANY of the following criteria will be excluded from participation in this study:

  1. Positive tests for anti-HIV1/2, anti-HCV, or HBsAg
  2. Does not meet criteria established by the NIH IRB-approved treatment protocol for administration of iPSCs, as created by the protocol PI.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056613


Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
Investigators
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Principal Investigator: David F Stroncek, M.D. National Institutes of Health Clinical Center (CC)
Publications:
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Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT02056613    
Other Study ID Numbers: 140057
14-CC-0057
First Posted: February 6, 2014    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: November 1, 2018
Keywords provided by National Institutes of Health Clinical Center (CC):
Blood Donation
Tissue Procurement
Cellular Therapies