Safety Study of Unlicensed, Investigational Cord Blood Units Manufactured by the NCBP for Unrelated Transplantation
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|ClinicalTrials.gov Identifier: NCT01656603|
Recruitment Status : Recruiting
First Posted : August 3, 2012
Last Update Posted : March 23, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Infusion Reactions||Biological: unlicensed CBU||Phase 2|
The primary aim of this study is to examine the safety of administration of the unlicensed investigational NCBP hematopoietic progenitor cell-cord blood (HPC-CORD BLOOD) products in a multi-institution setting. Therefore, the study will evaluate prospectively the incidence of serious adverse reactions as well as the incidence of all infusion related reactions after administration of the unlicensed, investigational NCBP CBU.
Definitions of Infusion-related adverse reactions:
Mild - Moderate: reactions during or after the infusion of the cord blood (CB) product that require some medical intervention but do not affect the overall patient status or outcome.
Severe: serious, life-threatening or fatal infusion reactions, requiring major medical intervention. These include: anaphylactic shock, acute cardiac, pulmonary or renal failure, seizures, patient transfer to the Intensive Care Unit, or death within 48 hours of the CB infusion. Adverse Reactions will also be classified by grade, according to the Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||9999 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2012|
|Estimated Primary Completion Date :||December 2025|
|Estimated Study Completion Date :||December 2025|
Experimental: unlicensed CBU
The Principal Investigators will be the transplant physicians at participating US transplant centers
Biological: unlicensed CBU
infusion of unlicensed cord blood units
- Incidence of infusion-related reactions [ Time Frame: within 48 hours of infusion ]The primary aim of this study is to examine the safety of administration of the unlicensed investigational cord blood products in a multi-institution setting. The study will evaluate prospectively the incidence of serious adverse reactions as well as the incidence of all infusion related reactions after administration of the unlicensed, investigational NCBP cord blood units.
- engraftment [ Time Frame: six months after transplant ]This outcome will evaluate engraftment of unlicensed cord blood units
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01656603
|Contact: Dorothy Sungemail@example.com|
|Contact: Emeline Masson Frenetfirstname.lastname@example.org|
|Principal Investigator:||Alexandra Jimenez, MD||NY Blood Center|
|Responsible Party:||New York Blood Center|
|Other Study ID Numbers:||
|First Posted:||August 3, 2012 Key Record Dates|
|Last Update Posted:||March 23, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|