NCT01656603 · New York Blood Center
Safety Study of Unlicensed IND Cord Blood Units Manufactured by the National Cord Blood Program for Unrelated Transplantation
What this study is about
This study will evaluate the safety of infusion of the experimental cord blood units by carefully documenting all infusion-related problems.
View original scientific description
This study will evaluate the safety of infusion of the investigational cord blood units by carefully documenting all infusion-related problems.
Interventions
BIOLOGICAL
unlicensed CBU
infusion of unlicensed cord blood units
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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.)
Where
- Birmingham, Alabama
- Phoenix, Arizona
- Tucson, Arizona
- Duarte, California
- La Jolla, California
- Los Angeles, California
- San Diego, California
- Stanford, California
- Aurora, Colorado
- Denver, Colorado
- Wilmington, Delaware
- Washington D.C., District of Columbia
And 44 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 13, 2026 · Source of record for eligibility and locations