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NCT01656603 · ClinicalTrials.gov registry record · Phase 2
Safety Study of Unlicensed IND Cord Blood Units Manufactured by the National Cord Blood Program for Unrelated Transplantation
A Phase 2 study of Infusion Reactions, sponsored by New York Blood Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 20
- Study locations
NCT01656603: Recruiting Phase 2 study of Infusion Reactions, sponsored by New York Blood Center.
NCT01656603 is a Phase 2 study of Infusion Reactions that is actively recruiting participants, run by New York Blood Center. The registry lists this as an open-ended (no fixed target) study. The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01656603, a Phase 2 study of Infusion Reactions, is actively recruiting participants, sponsored by New York Blood Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- open-ended (no fixed target)
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the safety of infusion of the investigational cord blood units by carefully documenting all infusion-related problems.
Primary Outcome
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.
Conditions Studied
Interventions
- BIOLOGICAL unlicensed CBU
Study Locations (20)
California
- City of Hope - Duarte
- UCSD Moores Cancer Center - La Jolla
- Cedars Sinai Medical Center - Los Angeles
- UCLA Healthcare - Los Angeles
- Rady Children's Hospital - San Diego
- Stanford Health Care - Stanford
Florida
- Nemour's Children's Clinic and Hospital - Jacksonville
- University of Miami Health System Sylvester Comprehensive Cancer Center - Miami
- University of Miami/Jackson Memorial Hospital - Miami
- Florida Hospital, Florida Center for Cellular Therapy - Orlando
- All Children's Hospital, John Hopkins Medicine - St. Petersburg
Arizona
- Phoenix Children's Hospital - Phoenix
- Mayo Clinic Arizona - Phoenix
- University of Arizona Medical Center - Tucson
Colorado
- The Children's Hospital of Colorado - Aurora
- University of Colorado Hospital - Aurora
- Presbyterian / St. Luke's Medical Center - Denver
Alabama
- Children's of Alabama - Birmingham
Delaware
- Alfred I. DuPont Hospital for Children - Wilmington
District of Columbia
- Children's National Medical Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | open-ended (no fixed target) |
| Start Date | 2012-02 |
| Est. Completion | 2025-12 |
| Phase | Phase 2 |
What NCT01656603 shows while recruiting
NCT01656603 is an interventional study that assigns participants to a tested intervention. The registry lists this as an open-ended (no fixed target) study, common for long-running registries that collect data indefinitely.
The record links to 1 condition, with Infusion Reactions appearing as the primary indexed condition, and to 1 intervention - of which unlicensed CBU is the first listed.
NCT01656603 names 20 study sites across 7 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT01656603 about?
NCT01656603 is a clinical study titled "Safety Study of Unlicensed IND Cord Blood Units Manufactured by the National Cord Blood Program for Unrelated Transplantation". This study will evaluate the safety of infusion of the investigational cord blood units by carefully documenting all infusion-related problems.
What is the current status of trial NCT01656603?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is open-ended (no fixed target). The study started on 2012-02. Estimated completion is 2025-12.
What conditions does trial NCT01656603 study?
This clinical trial studies the following conditions: Infusion Reactions.
What interventions are being tested in trial NCT01656603?
The interventions under investigation include: unlicensed CBU (BIOLOGICAL).
Who is sponsoring clinical trial NCT01656603?
This trial is sponsored by New York Blood Center, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01656603 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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