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Evaluating the safety of unlicensed cord blood units for transplantation

A Multicenter Safety Study of Unlicensed, Investigational Cryopreserved Cord Blood Units Manufactured by the National Cord Blood Program and Provided for Unrelated Hematopoietic Stem Cell Transplantation of Pediatric and Adult Patients

Phase 2 Interventional New York Blood Center · NCT01656603

This study is testing whether using unlicensed cord blood units for transplantation is safe for patients by looking at any side effects that might happen during or after the treatment.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment9999 (estimated)
SexAll
SponsorNew York Blood Center Academic / other
Locations71 sites (Birmingham, Alabama and 70 other locations)
Trial IDNCT01656603 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include patients of any age with hematopoietic system disorders who require cord blood transplantation.

Not a fit: Patients receiving licensed cord blood products or those treated at non-US transplant centers may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the safety profile of cord blood transplantation, potentially improving outcomes for patients with hematopoietic disorders.

How similar studies have performed: Other studies have explored the safety of cord blood transplantation, but this specific approach with unlicensed products is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Birmingham, Alabama and 70 other locations

+21 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Infusion Reactionscord bloodtransplantationstem cellsadverse event
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.