RecruitingPhase 2

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

United States9,999 participantsStarted 2012-02

Plain-language summary

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

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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)

✕. 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.)

Incidence of infusion-related reactions

Timeframe: within 48 hours of infusion

NCT IDNCT01656603

SponsorNew York Blood Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-12

Dorothy Sung