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Pilot Study Freeze and Transport Immune Cells

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00138268
First received: August 26, 2005
Last updated: August 26, 2010
Last verified: October 2007
History of Changes
  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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

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

No publications provided

ClinicalTrials.gov Identifier: NCT00138268     History of Changes
Other Study ID Numbers: 03-236
Study First Received: August 26, 2005
Last Updated: August 26, 2010
Health Authority: Unspecified

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

Additional relevant MeSH terms:
Diphtheria
Hepatitis
Hepatitis A
Hepatitis B
Whooping Cough
Poliomyelitis
Tetanus
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Myelitis
Central Nervous System Viral Diseases
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013