The Collection and Storage of Umbilical Cord Blood for Transplantation

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01728545
First received: November 9, 2012
Last updated: September 8, 2014
Last verified: September 2014
  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 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.

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 in laboratory studies designed 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Public Cord Blood Banking [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    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
Study Start Date: April 2005
Estimated Primary Completion Date: June 2099 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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, hemoglobinopathy screening and microbial cultures.

Exclusion Criteria:

N/A

  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 ClinicalTrials.gov identifier: 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
Investigators
Study Chair: Elizabeth Shpall, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01728545     History of Changes
Other Study ID Numbers: LAB04-0249, R01CA061508
Study First Received: November 9, 2012
Last Updated: September 8, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Retinitis Pigmentosa
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Retinal Degeneration
Retinal Diseases
Retinal Dystrophies

ClinicalTrials.gov processed this record on October 29, 2014