Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (16)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphocytic Leukemia | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Acute Myelogenous Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
| Adrenoleukodystrophy | — | UNRESOLVED | — |
| Amegakaryocytic Thrombocytopenia | — | UNRESOLVED | — |
| Batten Disease | — | UNRESOLVED | — |
| Diamond-Blackfan Anemia | — | UNRESOLVED | — |
| Fucosidosis | — | UNRESOLVED | — |
| Gaucher's Disease | — | UNRESOLVED | — |
| Krabbe's Disease | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Human Placental Derived Stem Cell | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Group A
- description
- related cord blood with ≥3/6 HLA match to the patient and related HPDSC
- interventionNames
- Drug: Human Placental Derived Stem Cell
- type
- EXPERIMENTAL
- label
- Group B
- description
- unrelated cord blood with ≥ 4/6 HLA match to the patient and unrelated HPDSC
- interventionNames
- Drug: Human Placental Derived Stem Cell
- type
- EXPERIMENTAL
- label
- Group C
- description
- unrelated cord blood with ≥4/6 HLA match to the patient but related to HPDSC
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
- Maximum age
- 55 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available