NCT01728545

Brief Summary

The goal of this study is to collect blood samples from the umbilical cords of newborn babies, as soon as they are delivered, and to place these samples in the MD Anderson Cord Blood Bank. Your sample may be included in the National Cord Blood Inventory (NCBI) which is part of the CW Bill Young Cell Transplantation Program. The NCBI is a federally-supported program to assist in the collection of cord blood. Cord blood will be made available to patients through The National Marrow Donor Program (NMDP). These samples may then be offered to MD Anderson and other institutions for patients who need a bone marrow transplant and do not have a donor. The MD Anderson Cord Blood Bank will have the rights to release cord blood units to these institutions around the world according to established bone marrow transplant donor criteria, for a fee to cover costs. Cord blood samples that are collected and then do not meet the clinical requirements for patient use may also be used at MD Anderson or other institutions either for research or for quality purposes to improve cord blood banking procedures. If not suitable for patient use or for research purposes, the cord blood unit may be thrown away.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250,000

participants targeted

Target at P75+ for all trials

Timeline
887mo left

Started Apr 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Apr 2005Apr 2099

Study Start

First participant enrolled

April 1, 2005

Completed
7.6 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 20, 2012

Completed
86.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2099

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2099

Last Updated

May 13, 2019

Status Verified

May 1, 2019

Enrollment Period

94.1 years

First QC Date

November 9, 2012

Last Update Submit

May 10, 2019

Conditions

Cord Blood Stem Cell TransplantationCord Blood TransplantationHematopoietic Stem Cell Transplantation

Keywords

Cord blood registryUmbilical Cord Bloodfetal bloodplacentaPlacental Blood Stem Cell Transplantationhematopoietic progenitor cellsHematopoietic Stem Cell Transplantationcord blood unit total nucleated cellTNCCD34-positive(+) cellhuman leukocyte antigenHLAallogeneic transplantation

Outcome Measures

Primary Outcomes (1)

  • Public Cord Blood Banking

    Collection and storage of umbilical cord blood units from normal donors for banking and ultimate transplantation into patients.

    10 years

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Neonates delievered by women age 18 years or older.

You may qualify if:

  • Pregnant women age 18 or older. Cord blood will not be collected from a minor.
  • Able to give verbal informed consent prior to collection of the cord blood.
  • Able to give written informed consent prior to collection of the cord blood.
  • Willing to provide a personal and family medical history (if available) of herself and the biologic father (if available), prior to or following collection of the cord blood.
  • Willing to consent to testing of her blood and the cord blood for infectious diseases, including human immunodeficiency virus (HIV), human T cell lymphotrophic virus (HTLV), hepatitis B and C, cytomegalovirus (CMV), syphilis (RPR), Trypanosoma cruzi (Chagas) and West Nile Virus (WNV). Incomplete tests or positive infectious disease testing results may result in the cord blood unit being deemed unacceptable for clinical use.
  • Willing to consent to testing the cord blood for HLA type, ABO/RhD type, newborn screening and microbial cultures.

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MD Anderson Cord Blood Bank Collection Sites

Houston, Texas, 77030, United States

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples from the umbilical cords of newborn babies, a minimum of 40 ml is needed for processing.

Study Officials

  • Elizabeth Shpall, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Central Study Contacts

Elizabeth Shpall, MD

CONTACT

713-745-2161eshpall@mdanderson.org

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2012

First Posted

November 20, 2012

Study Start

April 1, 2005

Primary Completion (Estimated)

April 1, 2099

Study Completion (Estimated)

April 1, 2099

Last Updated

May 13, 2019

Record last verified: 2019-05

Locations

US(1)