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

RECRUITING

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

I'm interested

ALL
This study is NOT accepting healthy volunteers

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.)

BIOLOGICAL: unlicensed CBU

Infusion Reactions

cord blood, transplantation, stem cells, adverse event

Stephanie Edwards - stephanieL.edwards@cchmc.org
PHASE2
NCT01656603
See this study on ClinicalTrials.gov

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