Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Pilot Study Freeze and Transport Immune Cells

This study has been completed.
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID) Identifier:
First received: August 26, 2005
Last updated: August 26, 2010
Last verified: October 2007
To evaluate and standardize umbilical cord specimen collection and laboratory procedures to evaluate cellular and serological immune responses in neonates and young infants

Hepatitis B

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:

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders 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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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)
  More Information 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:
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 processed this record on October 21, 2016