Trial Information
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
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
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
Incidence of GVHD, time to engraftment and survival
Outcome Time Frame:
2 years
Safety Issue:
Yes
Principal Investigator
Lolie Yu, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Louisiana State University Children's Hospital
Authority:
United States: Institutional Review Board
Study ID:
CCT-HPDSC-001
NCT ID:
NCT00596999
Start Date:
May 2007
Completion Date:
December 2013
Related Keywords:
- Hematologic Malignancies
- 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)
- Neoplasms
- Hematologic Neoplasms
Name | Location |
Louisiana State University Children's Hospital |
New Orleans, Louisiana 70118 |