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

NCT00596999 | Unknown DMC

• 1 other identifier: CCT-HPDSC-001
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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

Conditions

Hematologic Malignancies

Keywords

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)

Outcome Measures

Primary Outcomes (1)

• Incidence of GVHD, time to engraftment and survival

  2 years

Study Arms (1)

1

all subjects will be treated with UCB and HPDSC

Procedure: UCB and HPDSC

Interventions

UCB and HPDSC PROCEDURE

single dose of UCB followed by one unit of HPDSC

1

Eligibility Criteria

• Age: Up to 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

subjects requiring cord blood transplantation

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Celgene Corporation: lead

Study Sites (1)

Louisiana State University Children's Hospital

New Orleans, Louisiana, 70118, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms; Myelodysplastic Syndromes; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Anemia, Sickle Cell; beta-Thalassemia; Metabolism, Inborn Errors; X-Linked Combined Immunodeficiency Diseases

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Thalassemia; Metabolic Diseases; Nutritional and Metabolic Diseases; Genetic Diseases, X-Linked; Severe Combined Immunodeficiency; Primary Immunodeficiency Diseases; Infant, Newborn, Diseases; Immunologic Deficiency Syndromes

Study Officials

• Lolie Yu, MD

  Louisiana State University Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2008
• First Posted: January 17, 2008
• Study Start: May 1, 2007
• Primary Completion: July 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 10, 2012

Record last verified: 2007-11

Locations

US (1)