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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)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00596999
First received: January 8, 2008
Last updated: April 9, 2012
Last verified: November 2007
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Celgene Corporation:

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

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

Ages Eligible for Study:   up to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00596999     History of Changes
Other Study ID Numbers: CCT-HPDSC-001
Study First Received: January 8, 2008
Last Updated: April 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by 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:
Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases

ClinicalTrials.gov processed this record on May 21, 2013