NCT01451502 Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units
| NCT ID | NCT01451502 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Masonic Cancer Center, University of Minnesota |
| Condition | Lymphatic Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2011-10-20 |
| Primary Completion | 2026-09 |
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.
This trial targets 250 participants in total. It began in 2011-10-20 with a primary completion date of 2026-09.
⚠ 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
For the next 5-10 years or possibly longer, a high proportion of the Cord Blood Banks (CBB) inventory worldwide will be composed of unlicensed umbilical cord blood (UCB) units. While Food and Drug Administration (FDA)-licensed units will be prioritized, it will always be possible that an unlicensed unit will have known attributes, making it a better source of cells for the given indication. Because of the wide variety of current and potential indications as a source of cells for hematopoietic reconstitution or other form of cellular therapy, it is critical that the investigators have access to unlicensed UCB units.
Eligibility Criteria
Inclusion Criteria: To be eligible for an unlicensed umbilical cord blood (UCB) unit, the subject must meet each of the eligibility criteria listed below: * Subjects with any diagnosis for which there is an institutional review board (IRB) approved treatment protocol that requires UCB as a source of hematopoietic stem cells for lympho-hematopoietic reconstitution after myeloablative or non myeloablative conditioning. * Subject (or parent/guardian) must provide written informed consent for the use of unlicensed UCB units with co-enrollment onto a University of Minnesota IRB-approved clinical trial that details the disease specific treatment plan that prescribes the use of UCB as source of cells * Subject has an unlicensed UCB unit that meets required cell dose and HLA matching criteria (as defined in the primary treatment protocol) that is considered negative for tested blood-borne pathogens and also lack an 'equivalent', licensed UCB unit from a University of Minnesota approved Cord Blood Bank Exclusion Criteria: * Exclusion criteria are specified in the treatment protocol according to indication.
Contact & Investigator
Alex Hoover, MD, MSc
PRINCIPAL INVESTIGATOR
Masonic Cancer Center, University of Minnesota
Frequently Asked Questions
Who can join the NCT01451502 clinical trial?
This trial is open to participants of all sexes, studying Lymphatic Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01451502 currently recruiting?
Yes, NCT01451502 is actively recruiting participants. Visit ClinicalTrials.gov or contact Masonic Cancer Center, University of Minnesota to inquire about joining.
Where is the NCT01451502 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT01451502 clinical trial?
NCT01451502 is sponsored by Masonic Cancer Center, University of Minnesota. The principal investigator is Alex Hoover, MD, MSc at Masonic Cancer Center, University of Minnesota. The trial plans to enroll 250 participants.