Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Single-arm Safety Study of Transplantation Using Umbilical Cord Blood and Human Placental-derived Stem Cells From Partially Matched Related Donors in Persons With Certain Malignant Blood Diseases and Non-malignant Disorders (HPDSC)

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.
 
ClinicalTrials.gov Identifier: NCT00596999
Recruitment Status : Unknown
Verified November 2007 by Celgene ( Celgene Corporation ).
Recruitment status was:  Enrolling by invitation
First Posted : January 17, 2008
Last Update Posted : April 10, 2012
Sponsor:
Information provided by (Responsible Party):
Celgene ( Celgene Corporation )

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
To investigate the safety of partially matched related human placental-derived stem cells (HPDSC) administered in conjunction with umbilical cord blood (UCB) stem cells from the same donor in subjects with various malignant or nonmalignant disorders potentially curable with stem cell transplantation and to assess potential restoration of normal hematopoiesis and immune function in subjects with these disorders

Condition or disease Intervention/treatment
Hematologic Malignancies Procedure: UCB and HPDSC

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 6 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Single-Arm Study to Assess the Safety of Transplantation With Umbilical Cord Blood Augmented With Human Placental-Derived Stem Cells From Partially Matched Related Donors in Subjects With Certain Malignant Hematologic Diseases and Non-Malignant Disorders
Study Start Date : May 2007
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Disorders

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
1
all subjects will be treated with UCB and HPDSC
 Procedure: UCB and HPDSC
single dose of UCB followed by one unit of HPDSC


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Incidence of GVHD, time to engraftment and survival [ Time Frame: 2 years ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
Ages Eligible for Study:   up to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
subjects requiring cord blood transplantation
Criteria

Inclusion Criteria:

  • suitable UCB collected from partially or fully HLA matched related donor
  • subject requires umbilical cord transplantation

Exclusion Criteria:

  • any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
  • major anticipated illness or organ failure incompatible with survival from stem cell transplant
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00596999


Locations
Layout table for location information
United States, Louisiana
Louisiana State University Children's Hospital
New Orleans, Louisiana, United States, 70118
Sponsors and Collaborators
Celgene Corporation
Investigators
Layout table for investigator information
Principal Investigator: Lolie Yu, MD Louisiana State University Children's Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00596999    
Other Study ID Numbers: CCT-HPDSC-001
First Posted: January 17, 2008    Key Record Dates
Last Update Posted: April 10, 2012
Last Verified: November 2007
Keywords provided by Celgene ( Celgene Corporation ):
Myelodysplastic Syndrome (MDS)
Acute myelogenous Leukemia (AML)
Acute Lymphocytic Leukemia (ALL)
Sickle Cell Disease (SCD)
 Beta Thalassemia
Inborn Errors of Metabolism
Severe Combined Immunodeficiency Disease (SCID)
Additional relevant MeSH terms:
Layout table for MeSH terms
Hematologic Neoplasms
Neoplasms
Neoplasms by Site
Hematologic Diseases