Northside Hospital Research Program

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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

Learn more:
http://www.clinicaltrials.gov/ct2/show/NCT01656603
Protocol Number
NSH995
Phase
Other
Management Group
BMT Program
Oncology Group
BMT Oncology Group
Disease Sites
Hodgkin's Lymphoma
Leukemia, other
Lymphoid Leukemia
Multiple Myeloma
Myeloid and Monocytic Leukemia
Non-Hodgkin's Lymphoma
Other Hematopoietic
Sponsor Protocol
NCBP 6637-01
Principal Investigator
Scott Solomon
Participating Institutions
Northside Hospital - Atlanta (BMT)

Treatment

After signing the consent and review of eligibility, the cord blood unit(s) will be infused into one of your veins. Receiving the cord blood unit transplant and allowing your medical data to be collected are the procedures involved in this study. Treatment, including pre-transplant conditioning, selection of Cord Blood Unit ( CBU) and Graft Versus Host Disease (GVHD) prophylaxis, will be according to the transplant center?s practices, and will be discussed in the treatment informed consent.

Description

This study will evaluate the safety of administration of the investigational cord blood units by carefully documenting all infusion-related problems of pediatric and adult patients in a multi-institution setting.

Key Eligibility

Inclusion Criteria 1. Patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment. 2. Patients of any age and either gender 3. CBU: Hematopoietic Progenitor cells ? (CORD BLOOD HPC-CORD BLOOD) product manufactured by the National Cord Blood Program (NCBP) (at least one, if the graft contains more than one units) Exclusion Criteria 1. Patients who are receiving licensed Core Blood (CB) products (only) 2. Patients who are receiving unlicensed CB products from other CB banks (only) 3. Patients who are transplanted at non-US transplant centers 4. Patients who are receiving CB products that will be ?manipulated? post-thaw (e.g., ex vivo expansion, incubation in vitro, etc.)

Want to learn more?

For further information on our clinical trials, please call the Northside Hospital Research Program at (404) 303-3355 or

Email Us

For further information on our clinical trials, please contact the Northside Hospital Research Program at
(404) 303-3355 or