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Safety Study of Cord Blood Units for Stem Cell Transplants
Recruiting
I'm InterestedTrial ID: NCT01861093
Purpose
Background:
- Cord blood is blood that is taken from the umbilical cord and placenta of healthy newborns
after childbirth. The cord blood collected from a baby is called a cord blood unit. Cord
blood units are stored frozen in public cord blood banks. About 10,000 cord blood transplants
have been performed in children and adults for blood cancers and other diseases in the world.
These transplants have helped save lives and improve treatments. However, not all available
units of cord blood have been collected, stored, and licensed according to specific
government requirements. These unlicensed units can still be used in transplant, but they can
only be given as part of specific research studies. This study will evaluate the safety of
giving these unlicensed units by recording any problems that may occur during and after
giving the cord blood.
Objectives:
- To test the safety and effectiveness of unlicensed cord blood units in people who need stem
cell transplants.
Eligibility:
- Individuals who are scheduled to have a stem cell transplant.
Design:
- Participants will be screened with a medical history and physical exam.
- Participants will receive the cord blood unit as part of their stem cell transplant
procedure. The transplant will be performed according to the current standard of care
for the procedure.
- After the transplant, participants will be monitored for up to 1 year. Any problems or
side effects from the transplant will be treated as necessary. All outcomes will be
reported to the National Cord Blood Program and to the Center for International Blood
and Marrow Transplant.
Official Title
A Multicenter Safety Study of Unlicensed, Investigational Cryopreserved Cord Blood Units (CBUs) Manufactured by the National Cord Blood Program (NCBP) and Provided for Unrelated Hematopoietic Stem Cell Transplantation of Pediatric and Adult Patients
Stanford Investigator(s)
Andrew Rezvani, M.D.
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Eligibility
- INCLUSION CRITERIA:
- Patients of any age or either gender with indications for receipt of investigational
HPC-CORD BLOOD who are participating in an NIH-IRB approved clinical trial for
unrelated hematopoietic stem cell transplantation.
- Signed informed consent (and assent when applicable).
EXCLUSION CRITERIA:
- Patients who are receiving licensed CB products (only)
- Patients who are receiving unlicensed CB products from other CB banks (i.e. NMDP)
Intervention(s):
biological: Cord Blood Units
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Khanh Nguyen
650-736-2558