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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 recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2007 by Celgene ( Celgene Corporation ).
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT00596999
First Posted: January 17, 2008
Last Update Posted: April 10, 2012
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 (Responsible Party):
Celgene ( Celgene Corporation )
  Purpose
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 Intervention Phase
Hematologic Malignancies Procedure: UCB and HPDSC Phase 1

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Celgene ( Celgene Corporation ):

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

Estimated Enrollment: 6
Study Start Date: May 2007
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
all subjects will be treated with UCB and HPDSC
Procedure: UCB and HPDSC
single dose of UCB followed by one unit of HPDSC

  Eligibility

Information from the National Library of Medicine

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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
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
United States, Louisiana
Louisiana State University Children's Hospital
New Orleans, Louisiana, United States, 70118
Sponsors and Collaborators
Celgene Corporation
Investigators
Principal Investigator: Lolie Yu, MD Louisiana State University Children's Hospital
  More Information

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00596999     History of Changes
Other Study ID Numbers: CCT-HPDSC-001
First Submitted: January 8, 2008
First Posted: January 17, 2008
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)