Clinical trial · Observational
A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) for Transplantation in Pediatric and Adult Patients With Hematologic Malignancies and Other Indications
NCT01351545CI-TRIAL-00116819recruitingClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications.
Conditions
Conditions (17)
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 Lymphoblastic Leukemia (ALL) | Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.80 |
| Acute Myelogenous Leukemia (AML or ANLL) | Acute Myeloid Leukemia | ALIAS | 0.85 |
| Autoimmune Diseases | — | UNRESOLVED | — |
| Chronic Myelogenous Leukemia (CML) | Chronic Myeloid Leukemia, BCR-ABL1 Positive | CURATED_BROADER | 0.80 |
| Disorders of the Immune System | — | UNRESOLVED | — |
| Hematologic Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Histiocytic Disorders | — | UNRESOLVED | — |
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Inherited Abnormalities of Erythrocyte Differentiation or Function | — | UNRESOLVED |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Unlicensed CBU
- description
- The cohort includes recipients of any age receiving unlicensed cryopreserved cord blood units (CBUs) for designated indications.
- interventionNames
- Drug: A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs)
Primary outcomes (2)
- measure
- Neutrophil recovery of ≥500/mm3 after cord blood transplantation
- timeFrame
- Cord blood engraftment occurs in weeks following transplant is defined as defined as ANC 500/mm3 and is analyzed at 60 days post-transplant.
- description
- The primary objective of this access and distribution protocol is to examine the incidence of neutrophil recovery of ≥500/mm3 after cord blood transplantation in a multi-institution setting using CBUs that are not FDA licensed.
- measure
- Neutrophil recovery of ≥500/mm3 after cord blood transplantation
- timeFrame
- Cord blood engraftment occurs in weeks following transplant is defined as defined as ANC 500/mm3 and is analyzed at 100 days post-transplant.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment * Signed informed consent (and signed assent, if applicable) obtained prior to study enrollment * Pediatric and adult patients of any age Exclusion Criteria: * Patients who are receiving only licensed CBUs * Cord blood transplant recipients at international transplant centers * Patients who are enrolled on another IND protocol to access the unlicensed CBU(s) * Patients whose selected unlicensed CBU(s) will be more than minimally manipulated
References
Publications (0)
Data not yet available
No reference posted for this study.