Safety Study of Unlicensed IND Cord Blood Units Manufactured by the National Cord Blood Program for Unrelated Transplantation

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorNew York Blood Center

About this trial

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

Eligibility criteria

Qualifiers

Diagnosis: Patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment.

Patients: Patients of any age and either gender

Cord blood product manufactured by the NCBP (at least one, if the graft contains more than one units)

Disqualifiers

Patients who are receiving licensed cord blood products (only)

Patients who are receiving unlicensed cord blood products from other banks (only)

Patients who are transplanted at non-US transplant centers

Patients who are receiving cord blood products that will be "manipulated" post-thaw (e.g., ex vivo expansion, incubation in vitro, etc.)

Trial design

Treatments tested in this trial

  • unlicensed CBU

Treatment groups

9,999 Participants
are divided into 1 treatment group

Locations

71
Alabama
Children's of Alabama35233, Birmingham United States
Arizona
Mayo Clinic Arizona85054, Phoenix United States
Phoenix Children's Hospital85016, Phoenix United States
University of Arizona Medical Center85724, Tucson United States

Sponsors and collaborators

New York Blood Center

Lead sponsor