Evaluating the safety of unlicensed cord blood units for transplantation

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 aims to assess the safety of administering unlicensed investigational cord blood units manufactured by the National Cord Blood Program in a multi-institutional setting. It will document the incidence of infusion-related adverse reactions, ranging from mild to severe, following the administration of these cord blood products. The study will utilize a prospective approach to carefully monitor and classify any adverse events that occur during or after the infusion process.

Why it matters

Who can join: the full rules

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.)

Where it's running

• Children's of Alabama
  Birmingham, Alabama, United States Recruiting
• Phoenix Children's Hospital
  Phoenix, Arizona, United States Recruiting
• City of Hope
  Duarte, California, United States Recruiting
• UCSD Moores Cancer Center
  La Jolla, California, United States Recruiting
• Rady Children's Hospital
  San Diego, California, United States Recruiting
• Stanford Health Care
  Stanford, California, United States Recruiting

+21 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Eric Gehrie, MD — New York Blood Center
• Study coordinator: Dorothy Sung
• Email: dsung@nybc.org
• Phone: 718-706-5202

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.