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 - Full Text View

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.

First Received: January 8, 2008 Last Updated: January 16, 2008 History of Changes

Sponsored by:	Celgene Corporation
Information provided by:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00596999

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 I

Study Type:	Observational
Study Design:	Case-Only, 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:

Genetics Home Reference related topics: adenosine deaminase deficiency beta thalassemia sickle cell disease X-linked severe combined immunodeficiency

MedlinePlus related topics: Cancer

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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 Cellular Therapeutics ( Herb Faleck, MD )
Study ID Numbers:	CCT-HPDSC-001
Study First Received:	January 8, 2008
Last Updated:	January 16, 2008
ClinicalTrials.gov Identifier:	NCT00596999 History of Changes
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)

Study placed in the following topic categories:

Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Hematologic Neoplasms
Hematologic Diseases
Severe Combined Immunodeficiency
Beta-thalassemia
Myelodysplastic Syndromes
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Thalassemia
Immunologic Deficiency Syndromes

Leukemia
Metabolism, Inborn Errors
Thalassemia Minor
Acute Myelocytic Leukemia
Preleukemia
Acute Myeloid Leukemia, Adult
Beta-Thalassemia
Sickle Cell Anemia
Anemia, Sickle Cell
Acute Lymphoblastic Leukemia

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Hematologic Neoplasms
Hematologic Diseases

ClinicalTrials.gov processed this record on September 11, 2009