NCT01656603 Safety Study of Unlicensed IND Cord Blood Units Manufactured by the National Cord Blood Program for Unrelated Transplantation
| NCT ID | NCT01656603 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | New York Blood Center |
| Condition | Infusion Reactions |
| Study Type | INTERVENTIONAL |
| Enrollment | 9,999 participants |
| Start Date | 2012-02 |
| Primary Completion | 2030-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 9,999 participants in total. It began in 2012-02 with a primary completion date of 2030-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will evaluate the safety of infusion of the investigational cord blood units by carefully documenting all infusion-related problems.
Eligibility Criteria
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.)
Contact & Investigator
Eric Gehrie, MD
PRINCIPAL INVESTIGATOR
New York Blood Center
Frequently Asked Questions
Who can join the NCT01656603 clinical trial?
This trial is open to participants of all sexes, studying Infusion Reactions. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT01656603 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT01656603 currently recruiting?
Yes, NCT01656603 is actively recruiting participants. Contact the research team at dsung@nybc.org for enrollment information.
Where is the NCT01656603 trial being conducted?
This trial is being conducted at Birmingham, United States, Phoenix, United States, Phoenix, United States, Tucson, United States and 11 additional locations.
Who is sponsoring the NCT01656603 clinical trial?
NCT01656603 is sponsored by New York Blood Center. The principal investigator is Eric Gehrie, MD at New York Blood Center. The trial plans to enroll 9,999 participants.