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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
Information provided by (Responsible Party):
Celgene ( Celgene Corporation ) Identifier:
First received: January 8, 2008
Last updated: April 9, 2012
Last verified: November 2007
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
all subjects will be treated with UCB and HPDSC
Procedure: UCB and HPDSC
single dose of UCB followed by one unit of HPDSC


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

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
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Please refer to this study by its identifier: NCT00596999

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

Responsible Party: Celgene Corporation Identifier: NCT00596999     History of Changes
Other Study ID Numbers: CCT-HPDSC-001
Study First Received: January 8, 2008
Last Updated: April 9, 2012

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) processed this record on June 23, 2017