Pilot Study Freeze and Transport Immune Cells

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. Identifier: NCT00138268
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : August 27, 2010
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:
To evaluate and standardize umbilical cord specimen collection and laboratory procedures to evaluate cellular and serological immune responses in neonates and young infants

Condition or disease
Diphtheria Hepatitis B Pertussis Poliomyelitis Tetanus

Detailed Description:
To evaluate: 1) The procedures for obtaining umbilical cord blood; 2) the methods for ensuring immune cell viability, freezing, and shipping; 3) the conditions for optimization of immune cell isolation procedures.

Study Type : Observational
Enrollment : 12 participants
Time Perspective: Prospective
Official Title: Pilot Study to Optimize and Standardize Umbilical Cord Blood Collection and the Isolation, Freezing and Transportation of Cells for Studies of Cellular Immune Responses to Immunization
Study Completion Date : February 2005

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

For the portion of the pilot study conducted at the UCLA CVR, an umbilical cord blood sample will be obtained from approximately 8 to 12 healthy pregnant women who are delivering neonates at the Obstetrical delivery ward of Harbor- UCLA Medical Center. Informed consent will not be obtained because the blood will be obtained after delivery from a clamped umbilical cord attached to the placenta (afterbirth) that otherwise would be discarded.

Exclusion Criteria:

A cord blood sample will not be collected from women who have requested special arrangements for a cord blood registry service.

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 identifier (NCT number): NCT00138268

United States, California
UCLA Center For Vaccine Research
Torrance, California, United States, 90502
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00138268     History of Changes
Other Study ID Numbers: 03-236
First Posted: August 30, 2005    Key Record Dates
Last Update Posted: August 27, 2010
Last Verified: October 2007

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
umbilical cord blood, vaccine, pregnant women

Additional relevant MeSH terms:
Hepatitis B
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases