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| ID | Type | Description | Link |
|---|---|---|---|
| NYMC IRB L-10,733 | Other Identifier | New York Medical College |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | related cord blood with ≥3/6 HLA match to the patient and related HPDSC |
|
| Group B | Experimental | unrelated cord blood with ≥ 4/6 HLA match to the patient and unrelated HPDSC |
|
| Group C | Experimental | unrelated cord blood with ≥4/6 HLA match to the patient but related to HPDSC |
|
| Group D | Experimental | double unrelated cord blood units with ≥4/6 HLA match to patient and each other and unrelated HPDSC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human Placental Derived Stem Cell | Drug | Infusions of thawed HPDSC to be given following UCB infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | 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. | 100 days |
| Measure | Description | Time Frame |
|---|---|---|
| donor chimerism | donor chimerism will be assessed at set timepoints | 1 year |
| engraftment | 1 year | |
| Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitchell S Cairo, MD | New York Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Denver | Colorado | United States | |||
| New York Medical College |
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|
| 100 days and 180 days |
| Relapse | 100 days and 180 days |
| Mortality | 1 year |
| Valhalla |
| New York |
| 10595 |
| United States |
| University of Utah | Salt Lake City | Utah | United States |
| ID | Term |
|---|---|
| D008059 | Mucopolysaccharidosis I |
| D009087 | Mucopolysaccharidosis VI |
| D000326 | Adrenoleukodystrophy |
| D009542 | Niemann-Pick Diseases |
| D007966 | Leukodystrophy, Metachromatic |
| D015223 | Wolman Disease |
| D007965 | Leukodystrophy, Globoid Cell |
| D005776 | Gaucher Disease |
| D005645 | Fucosidosis |
| D009472 | Neuronal Ceroid-Lipofuscinoses |
| D000741 | Anemia, Aplastic |
| D029503 | Anemia, Diamond-Blackfan |
| D009190 | Myelodysplastic Syndromes |
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D008661 | Metabolism, Inborn Errors |
| D053632 | X-Linked Combined Immunodeficiency Diseases |
| ID | Term |
|---|---|
| D009083 | Mucopolysaccharidoses |
| D002239 | Carbohydrate Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D016464 | Lysosomal Storage Diseases |
| D017520 | Mucinoses |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D020739 | Brain Diseases, Metabolic, Inborn |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020279 | Hereditary Central Nervous System Demyelinating Diseases |
| D056784 | Leukoencephalopathies |
| D003711 | Demyelinating Diseases |
| D038901 | X-Linked Intellectual Disability |
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D040181 | Genetic Diseases, X-Linked |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D018901 | Peroxisomal Disorders |
| D000309 | Adrenal Insufficiency |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
| D013106 | Sphingolipidoses |
| D020140 | Lysosomal Storage Diseases, Nervous System |
| D015616 | Histiocytosis, Non-Langerhans-Cell |
| D015614 | Histiocytosis |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008064 | Lipidoses |
| D008052 | Lipid Metabolism, Inborn Errors |
| D052439 | Lipid Metabolism Disorders |
| D052516 | Sulfatidosis |
| D015217 | Cholesterol Ester Storage Disease |
| D007232 | Infant, Newborn, Diseases |
| D019636 | Neurodegenerative Diseases |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D000080983 | Bone Marrow Failure Disorders |
| D001855 | Bone Marrow Diseases |
| D029502 | Anemia, Hypoplastic, Congenital |
| D012010 | Red-Cell Aplasia, Pure |
| D000080984 | Congenital Bone Marrow Failure Syndromes |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016511 | Severe Combined Immunodeficiency |
| D000081207 | Primary Immunodeficiency Diseases |
| D007153 | Immunologic Deficiency Syndromes |
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