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NCT00717535 Clinical Trial

Studying Umbilical Cord Blood From African-American Donors

Health Status Unknown Clinical Trial

Official title:
Investigation of the Total Nucleated Cell Yield of Cord Blood Units Collected From African-American Donors in Correlation With Gestational and Other Health Variables

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00717535
Other study ID # CDR0000598111
Secondary ID P30CA022453WSU-C
Status Withdrawn
Phase N/A
First received July 16, 2008
Last updated April 25, 2013
Start date August 2005
Est. completion date November 2009

Study information
Verified date April 2013
Source Barbara Ann Karmanos Cancer Institute
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

RATIONALE: Studying umbilical cord blood in the laboratory and gathering information about current and previous pregnancies from African-American umbilical cord blood donors may help doctors learn more about the umbilical cord blood of these donors.

PURPOSE: This clinical trial is looking at umbilical cord blood from African-American donors.

Description:

OBJECTIVES:

- To correlate the total nucleated cell yield of cord blood units from African-American cord blood donors with gestational history, maternal history, and delivery information.

OUTLINE: This is a multicenter study.

Donors complete questionnaires about their demographics, maternal history, gestational history, and delivery. Cord blood units (CBU) are collected in utero and transported to the Stem Cell Processing Laboratory where they are evaluated for CBU volume and cell count (i.e., total nucleated cell yield) and cryopreserved. The study results will then be used to devise future interventional strategies to improve the yield of nucleated cells of CBU.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date November 2009
Est. primary completion date November 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility DISEASE CHARACTERISTICS:

- African-American participant in the National Marrow Donor Program cord blood collection protocol C-2844

- Recruited from the Labor and Delivery Suites of the Detroit Medical Center or its affiliated sites

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- Not specified

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• cryopreservation

• questionnaire administration

• study of socioeconomic and demographic variables

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Barbara Ann Karmanos Cancer Institute National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation between total nucleated cell yield of cord blood units and gestational history, maternal history, and delivery information Within a year No
Primary Improvement in total nucleated cell yield of cord blood units from African-American donors Within a year No
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