We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cord Blood Stem Cell Transplantation Study (COBLT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000603
First Posted: October 28, 1999
Last Update Posted: April 14, 2016
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. Read our disclaimer for details.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
  Purpose
To evaluate if HLA-mismatched, unrelated-donor umbilical cord blood stem and progenitor cell units (UCBU) offered a clinically acceptable alternative to matched unrelated-donor allogeneic bone marrow for transplantation with 180-day disease free survival as the endpoint. HLA typing was performed using DNA-base high resolution methods to determine HLA alleles. Patients with "true" HLA 3/6 and 4/6 matches were evaluated. In addition, a separate study in adults addressed the problem of limited cell dose and engraftment failure. The study was not planned as a randomized comparative clinical trial. Instead, it is a phase II/III efficacy study.

Condition Intervention Phase
Anemia, Aplastic Fanconi Anemia Hematologic Diseases Leukemia Neoplasms Severe Combined Immunodeficiency Hematopoietic Stem Cell Transplantation Myelodysplastic Syndromes Procedure: stem cell transplantation Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: September 1996
Study Completion Date: October 2007
Primary Completion Date: October 2007 (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:   up to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Mothers of Infant-donors must complete a medical history form, have an uncomplicated delivery, and deliver at UCLA or Duke.

Patients are those who need a transplant but don't have a matched marrow donor or can't wait to find one.

  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): NCT00000603


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Shelly Carter The EMMES Corporation
OverallOfficial: Joanne Kurtzberg Duke University
  More Information

Additional Information:
Publications:

Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: COBLT
NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00000603     History of Changes
Other Study ID Numbers: 316
First Submitted: October 27, 1999
First Posted: October 28, 1999
Last Update Posted: April 14, 2016
Last Verified: January 2008

Additional relevant MeSH terms:
Severe Combined Immunodeficiency
Anemia
Myelodysplastic Syndromes
Preleukemia
Immunologic Deficiency Syndromes
Hematologic Diseases
Fanconi Anemia
Fanconi Syndrome
Anemia, Aplastic
Bone Marrow Diseases
Precancerous Conditions
Neoplasms
Immune System Diseases
Anemia, Hypoplastic, Congenital
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases
Renal Tubular Transport, Inborn Errors
Kidney Diseases
Urologic Diseases
Metabolism, Inborn Errors
Infant, Newborn, Diseases