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Infusion Reactions | Safety Study of Unlicensed, Investigational Cord Blood Units Manufactured by the NCBP for Unrelated Transplantation

Infusion Reactions research study

What is the primary objective of this study?

This study will evaluate the safety of infusion of the investigational cord blood units by carefully documenting all infusion-related problems.

Who is eligible to participate?

Inclusion Criteria: 1. Diagnosis: Patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment. 2. Patients: Patients of any age and either gender 3. Cord blood product manufactured by the NCBP (at least one, if the graft contains more than one units) Exclusion Criteria: 1. Patients who are receiving licensed cord blood products (only) 2. Patients who are receiving unlicensed cord blood products from other banks (only) 3. Patients who are transplanted at non-US transplant centers 4. Patients who are receiving cord blood products that will be \"manipulated\" post-thaw (e.g., ex vivo expansion, incubation in vitro, etc.)

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Infusion Reactions

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Biological:unlicensed CBUinfusion of unlicensed cord blood units

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

unlicensed CBUThe Principal Investigators will be the transplant physicians at participating US transplant centers

Study Status

Recruiting

Start Date: February 2012

Completed Date: December 2020

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Incidence of infusion-related reactions

Secondary Outcome: engraftment

Study sponsors, principal investigator, and references

Principal Investigator: Andromachi Scaradavou, MD

Lead Sponsor: New York Blood Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01656603

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