What this study is
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.
What's being tested
- Umbilical Cord Blood (UCB)
Intervention · BIOLOGICAL
Infusion of Minimally Manipulated UCB Units - the UCB unit will be infused through a central line according to institutional guidelines.
Study details
- Sponsor
- Masonic Cancer Center, University of Minnesota
- Conditions
- Lymphatic Diseases · Hematopoietic Malignancy
- Enrolling
- 250 people
- Starts
- 2011-10-20
- Est. completion
- 2028-02
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Sex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- Exclusion criteria are specified in the treatment protocol according to indication.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMasonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States
- Claudio Brunstein, MD · Contact612-625-3918bruns072@umn.edu
- Claudio Brunstein, MD · Principal investigator
Recruiting
Study team
Sponsor
Masonic Cancer Center, University of Minnesota
Study ID 2011LS079
Principal investigator
Alex Hoover, MD, MSc
Masonic Cancer Center, University of Minnesota
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.