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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


Phase 1
N/A
55 Years
Open (Enrolling by invite only)
Both
Hematologic Malignancies

Thank you

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