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NCT01451502Recruiting

Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units

Source: ClinicalTrials.gov · Last updated 6 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
250 (estimated)
First submitted
11 Oct 2011
Start date
20 Oct 2011
Primary completion date
31 Jan 2027
Lead sponsor
Masonic Cancer Center, University of Minnesota
NCT number
NCT01451502

What you commit to

  • Study type: Interventional
  • Planned participants: 250
  • From 20 Oct 2011 to the primary completion date, 31 Jan 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Exclusion criteria are specified in the treatment protocol according to indication.

Who the study is looking for

  • 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

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Masonic Cancer Center, University of Minnesota
Coordinator of this site? Confirm its status
MinneapolisUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.