NCT01586455

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: New York Medical College · Academic / Other
• Sex: All
• Age: 0 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Human Placental Derived Stem Cell	Infusions of thawed HPDSC to be given following UCB infusion.

Timeline

• Start date: 2013-04-01
• Primary completion: 2020-06-01
• Completion: 2022-09-01
• First posted: 2012-04-26
• Last updated: 2022-10-25

Locations

3 sites across 1 country: United States