We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Collection and Storage of Umbilical Cord Blood for Transplantation

This study is currently recruiting participants.
Verified August 2017 by M.D. Anderson Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01728545
First Posted: November 20, 2012
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose

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.


Condition
Cord Blood Stem Cell Transplantation Cord Blood Transplantation Hematopoietic Stem Cell Transplantation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Collection and Storage of Umbilical Cord Blood for Transplantation

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Public Cord Blood Banking [ Time Frame: 10 years ]
    Collection and storage of umbilical cord blood units from normal donors for banking and ultimate transplantation into patients.


Biospecimen Retention:   Samples With DNA
Blood samples from the umbilical cords of newborn babies, a minimum of 40 ml is needed for processing.

Estimated Enrollment: 250000
Actual Study Start Date: April 2005
Estimated Study Completion Date: April 2099
Estimated Primary Completion Date: April 2099 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Neonates delievered by women age 18 years or older.
Criteria

Inclusion Criteria

  1. Pregnant women age 18 or older. Cord blood will not be collected from a minor.
  2. Able to give verbal informed consent prior to collection of the cord blood.
  3. Able to give written informed consent prior to collection of the cord blood.
  4. 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.
  5. 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.
  6. Willing to consent to testing the cord blood for HLA type, ABO/RhD type, newborn screening and microbial cultures.

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01728545


Contacts
Contact: Elizabeth Shpall, MD 713-745-2161

Locations
United States, Texas
MD Anderson Cord Blood Bank Collection Sites Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Elizabeth Shpall, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Elizabeth Shpall, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01728545     History of Changes
Other Study ID Numbers: LAB04-0249
R01CA061508 ( U.S. NIH Grant/Contract )
First Submitted: November 9, 2012
First Posted: November 20, 2012
Last Update Posted: August 22, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
hematopoietic progenitor cells
Hematopoietic Stem Cell Transplantation
Cord blood registry
Umbilical Cord Blood
fetal blood
placenta
Placental Blood Stem Cell Transplantation
cord blood unit total nucleated cell
TNC
CD34-positive(+) cell
human leukocyte antigen
HLA
allogeneic transplantation