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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00596999

Acronym

HPDSC

Enrollment

Registered

2008-01-17

Start date

2007-05-31

Completion date

2013-12-31

Last updated

2012-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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)

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

Interventions

PROCEDUREUCB and HPDSC

single dose of UCB followed by one unit of HPDSC

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of GVHD, time to engraftment and survival	2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026