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A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)

Access to unlicensed frozen cord blood for research purposes.

Recruiting
All
Phase N/A

This study is for adults and children with blood-related diseases, using special cord blood units (CBUs) that are not approved by the Food and Drug Administration (FDA). Cord blood is blood taken from the umbilical cord after a baby is born, and it can help treat blood diseases. The main goal is to see if blood cells, called neutrophils, recover after using these CBUs. Researchers also want to know about infection risks, serious reactions, survival after one year, and problems like graft vs. host disease (GVHD), where the body attacks the new cells. The study is open to all ages with certain blood disorders. However, people already using FDA-approved CBUs, or those in other studies, can't join.

  • The study checks how well non-FDA-approved CBUs work for blood diseases.
  • Participants must sign consent and meet specific health criteria.
  • No international patients or those using licensed CBUs can join.
Study details
    Hematologic Malignancies
    Inherited Disorders of Metabolism
    Inherited Abnormalities of Platelets
    Histiocytic Disorders
    Acute Myelogenous Leukemia (AML or ANLL)
    Acute Lymphoblastic Leukemia (ALL)
    Other Acute Leukemia
    Chronic Myelogenous Leukemia (CML)
    Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases
    Other Leukemia
    Hodgkin Lymphoma
    Non-hodgkin Lymphoma
    Multiple Myeloma/ Plasma Cell Disorder (PCD)
    Inherited Abnormalities of Erythrocyte Differentiation or Function
    Disorders of the Immune System
    Autoimmune Diseases
    Severe Aplastic Anemia

NCT01351545

Center for International Blood and Marrow Transplant Research

19 April 2025

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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