Access and distribution of unlicensed cryopreserved cord blood units

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study focuses on the access and distribution of unlicensed cryopreserved cord blood units (CBUs) for pediatric and adult patients suffering from hematologic malignancies and other related disorders. The primary objective is to evaluate the incidence of neutrophil recovery after cord blood transplantation in a multicenter setting. Secondary objectives include assessing the transmission of infections, serious infusion reactions, overall survival rates, and the incidence of graft versus host disease. The study involves multiple U.S. transplant centers and aims to provide critical data on the use of non-FDA licensed CBUs.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Banner MD Anderson Cancer Center
  Gilbert, Arizona, United States Recruiting
• Phoenix Children's Hospital
  Phoenix, Arizona, United States Recruiting
• University of Arizona Medical Center - Tucson
  Tucson, Arizona, United States Recruiting
• Arkansas Children's Hospital
  Little Rock, Arkansas, United States Recruiting
• City of Hope
  Duarte, California, United States Recruiting

+92 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Elizabeth Fosberg, B.A.
• Email: 10-CBA@ndmp.org

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.