Human Placental-Derived Stem Cell Transplantation

A Single-Arm Study to Assess the Safety of Transplantation With Human Placental-Derived Stem-Cells Combined With Unrelated and Related Cord Blood in Subjects With Certain Malignant Hematologic Diseases and Non-Malignant Disorders

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01586455

Acronym

HPDSC

Enrollment

Registered

2012-04-26

Start date

2013-04-30

Completion date

2022-09-30

Last updated

2022-10-25

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

Conditions

Acute Lymphocytic Leukemia, Acute Myelogenous Leukemia, Adrenoleukodystrophy, Amegakaryocytic Thrombocytopenia, Batten Disease, Diamond-Blackfan Anemia, Fucosidosis, Gaucher's Disease, Krabbe's Disease, Metachromatic Leukodystrophy, Mucopolysaccharidosis I, Mucopolysaccharidosis VI, Myelodysplastic Syndrome, Niemann-Pick Disease, Severe Aplastic Anemia, Wolman Disease

Keywords

umbilical cord blood, stem cell transplantation, placental stem cell, inborn errors of metabolism, marrow failure, Severe Combined Immunodeficiency Disease, AML, ALL, MDS

Brief summary

The purpose of this clinical trial is to investigate the safety of human placental-derived stem cells (HPDSC) given in conjunction with umbilical cord blood (UCB) stem cells in patients with various malignant or nonmalignant disorders who require a stem cell transplant. Patients will get either full dose (high-intensity) or lower dose (low intensity) chemo- and immunotherapy followed by a stem cell transplantation with UCB and HPDSC.

Interventions

DRUGHuman Placental Derived Stem Cell

Infusions of thawed HPDSC to be given following UCB infusion.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

0 Years to 55 Years

Healthy volunteers

Inclusion criteria

* \< 55 years of age * Life expectancy greater than 3 months * Lansky performance status ≥ 50% (children) or Karnofsky performance status ≥ 70% (adults) or ECOG performance status 0-2 (adults) * DLCO \> 50 percent predicted * Left ventricular ejection fraction \> 40% estimated * Creatinine clearance or estimated GFR . 60 mL/min/1.73m2 * Serum bilirubin \< 1.5x upper limit of normal * Transaminases \< 3x upper limit of normal * Absence of uncontrolled infection * HIV negative

Exclusion criteria

* Fanconi Anemia * Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities * Uncontrolled infection * Pregnant or breast-feeding females * Received other investigational agents within 30 days prior to the start of the conditioning regimen

Design outcomes

Primary

Measure	Time frame	Description
Safety	100 days	to evaluate the safety of human placental-derived stem cells (HPDSC) administered in conjunction with umbilical cord blood (UCB) stem cells in patients with malignant and non-malignant diseases.

Secondary

Measure	Time frame	Description
donor chimerism	1 year	donor chimerism will be assessed at set timepoints
engraftment	1 year	—
Survival	100 days and 180 days	—
Relapse	100 days and 180 days	—
Mortality	1 year	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026