Pilot Study Freeze and Transport Immune Cells

This study has been completed.

Sponsored by:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00138268

Purpose

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

Condition
Diphtheria Hepatitis B Pertussis Poliomyelitis Tetanus

MedlinePlus related topics: Diphtheria Hepatitis Hepatitis B Polio and Post-Polio Syndrome Tetanus Whooping Cough

U.S. FDA Resources

Study Type:	Observational
Study Design:	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

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:	12
Estimated Study Completion Date:	February 2005

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00138268

Locations

United States, California
UCLA Center For Vaccine Research
Torrance, California, United States, 90502

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

More Information

Study ID Numbers:	03-236
Study First Received:	August 26, 2005
Last Updated:	January 24, 2008
ClinicalTrials.gov Identifier:	NCT00138268
Health Authority:	Unspecified

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

umbilical cord blood, vaccine, pregnant women

Study placed in the following topic categories:

Bacterial Infections
Liver Diseases
Spinal Cord Diseases
Whooping Cough
Hepatitis, Viral, Human
Tetanus
Whooping cough
Gram-Negative Bacterial Infections
Gram-Positive Bacterial Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Neuromuscular Diseases
Hepatitis B
Motor Neuron Disease

Cough
Picornaviridae Infections
Central Nervous System Diseases
Degenerative motor system disease
Diphtheria
Motor neuron disease
Hepatitis
Virus Diseases
Digestive System Diseases
Central Nervous System Infections
Poliomyelitis
DNA Virus Infections
Myelitis
Enterovirus Infections

Additional relevant MeSH terms:

Bordetella Infections
RNA Virus Infections
Corynebacterium Infections
Nervous System Diseases

Central Nervous System Viral Diseases
Infection
Hepadnaviridae Infections
Actinomycetales Infections

ClinicalTrials.gov processed this record on January 16, 2009