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

NCT02056613 | Withdrawn

• 2 other identifiers: 14005714-CC-0057
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 If participants have not withdrawn their consent, they may be contacted in the future to donate again.

Conditions

Induced Pluripotent Stem Cells

Keywords

Blood Donation; Tissue Procurement; Cellular Therapies

Outcome Measures

Primary Outcomes (1)

• collection of blood samples for production of iPSCs or iPSV-derived therapy products

  Ongoing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who meet ALL of the following criteria will be considered for enrollment into this study:
• 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.
• Able to provide informed consent.
• Meets the donation requirements established by AABB and FDA for allogeneic or autologous use with the exception of hemoglobin/hematocrit.

You may not qualify if:

• Subjects who meet ANY of the following criteria will be excluded from participation in this study as a third party donor or research volunteer:
• 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
• Febr le (temperature \>38 (Infinite)C)
• Hemoglobin level
• African American women \<11.5 grams/dL
• Other women \<12.0 grams/dL
• Men \<12.5 grams/dL
• HCT

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Related Publications (3)

• Takahashi K, Yamanaka S. Induction of pluripotent stem cells from mouse embryonic and adult fibroblast cultures by defined factors. Cell. 2006 Aug 25;126(4):663-76. doi: 10.1016/j.cell.2006.07.024. Epub 2006 Aug 10.

  PMID: 16904174 BACKGROUND

• Mostoslavsky G. Concise review: The magic act of generating induced pluripotent stem cells: many rabbits in the hat. Stem Cells. 2012 Jan;30(1):28-32. doi: 10.1002/stem.742.

  PMID: 21948613 BACKGROUND

• Somers A, Jean JC, Sommer CA, Omari A, Ford CC, Mills JA, Ying L, Sommer AG, Jean JM, Smith BW, Lafyatis R, Demierre MF, Weiss DJ, French DL, Gadue P, Murphy GJ, Mostoslavsky G, Kotton DN. Generation of transgene-free lung disease-specific human induced pluripotent stem cells using a single excisable lentiviral stem cell cassette. Stem Cells. 2010 Oct;28(10):1728-40. doi: 10.1002/stem.495.

  PMID: 20715179 BACKGROUND

Study Officials

• David F Stroncek, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2014
• First Posted: February 6, 2014
• Study Start: February 5, 2014
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: November 5, 2018

Record last verified: 2018-11-01