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

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Trial ID: NCT01861093

Purpose

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

Official Title

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

Stanford Investigator(s)

Andrew Rezvani, M.D.
Andrew Rezvani, M.D.

Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Parveen Shiraz, MD
Parveen Shiraz, MD

Instructor, Medicine - Blood & Marrow Transplantation

Eligibility

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.)

Intervention(s):

biological: unlicensed CBU

Recruiting

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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Khanh Nguyen
650-736-2558