Lymphatic DiseasesNCT01451502
Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units
A study testing Umbilical Cord Blood (UCB) in people with Lymphatic Diseases and Hematopoietic Malignancy, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lymphatic Diseases, Hematopoietic Malignancy
- What is being tested?
- Umbilical Cord Blood (UCB)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2011to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Exclusion criteria are specified in the treatment protocol according to indication.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
Claudio Brunstein, MD, 612-625-3918, bruns072@umn.edu
Claudio Brunstein, MD
About this study
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.
Read the detailed description
Patients will receive intravenous hydration, acetaminophen and diphenhydramine hydrochloride (or appropriate alternative regimen) approximately 30 minutes prior to UCB infusion with doses adjusted for subject age and weight unless otherwise specified in the specific treatment protocol. Additional treatments will vary with the specific use of the UCB cells as specified in institutional review board (IRB)-approved disease-specific protocols at the University of Minnesota.
- Conditions
- Lymphatic Diseases, Hematopoietic Malignancy
- Being tested
- Umbilical Cord Blood (UCB)
- Keywords
- umbilical cord blood
- Medical subject headings
- Lymphatic Diseases, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical Cord Blood (UCB)Biological
Infusion of Minimally Manipulated UCB Units - the UCB unit will be infused through a central line according to institutional guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Unlicensed Umbilical Cord Blood Infusion | Experimental | All patients will be registered in OnCore under this protocol as well as the specific treatment protocol.
* Pre-infusion treatment using intravenous hydration, acetaminophen and diphenhydramine hydrochloride
* Unlicensed Umbilical Cord Blood Infusion according to institutional guidelines.
* Infusion of minimally manipulated unlicensed UCB units:
* vital signs Monitoring during and after UCB infusion:
* Management of infusion reactions
* Post-transplant care and follow-up: will be done according to the disease specific treatment protocol and institutional guidelines. Receives: Biological: Umbilical Cord Blood (UCB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Blood Borne Pathogen Transmission from Unlicensed UCB Units.
Documentation of events for the purpose of this study will only be for those events at least possibly related to the unlicensed UCB. Monitoring for acute infusional toxicities will end 24 hours after the umbilical cord blood (UCB) infusion.
Measured: Within 24 Hours Post Infusion
Secondary outcomes (4)
Incidence of Serious Infusion Reactions of Minimally Manipulated Unlicensed UCB Units
point estimations and 95% confidence intervals of serious infusion reaction
Measured: Up to Day 180
Number of the Desired Lineage Specific Cells in Minimally Manipulated Unlicensed UCB Units
Upon thawing (e.g., number of CD34 and colony forming cells for hematopoietic products or number of CD4+/CD25+/CD127- cells for Treg products prior to further manipulation).
Measured: Prior to Infusion
Incidence of Mislabeled UCB Units
Point estimations and 95% confidence intervals of incidences mislabeled UCB units
Measured: Up to Day 180
Comparison of Specific Cord Blood Banks (CBBs)
Determine if bacterial contamination, poor cell recoveries, shipment of mislabeled units, blood borne pathogen transmission or serious infusion reactions are more prevalent in units from specific CBBs.
Measured: Up to Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2011 (estimated)
- Study start20 Oct 2011
- Primary completionJan 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphatic DiseasesStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alex Hoover, MD, MSc, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01451502
- Sponsor's protocol ID
- 2011LS079
- Other IDs
- MT2011-13R
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2011
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units
- ClinicalTrials.gov ID
- NCT01451502
- Acronym / sponsor ID
- 2011LS079
- Conditions
- Lymphatic Diseases, Hematopoietic Malignancy
- Keywords
- umbilical cord blood
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 20 Oct 2011 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 13 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients will receive intravenous hydration, acetaminophen and diphenhydramine hydrochloride (or appropriate alternative regimen) approximately 30 minutes prior to UCB infusion with doses adjusted for subject age and weight unless otherwise specified in the specific treatment protocol. Additional treatments will vary with the specific use of the UCB cells as specified in institutional review board (IRB)-approved disease-specific protocols at the University of Minnesota.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unlicensed Umbilical Cord Blood Infusion | Experimental | Biological: Umbilical Cord Blood (UCB)All patients will be registered in OnCore under this protocol as well as the specific treatment protocol. * Pre-infusion treatment using intravenous hydration, acetaminophen and diphenhydramine hydrochloride * Unlicensed Umbilical Cord Blood Infusion according to institutional guidelines. * Infusion of minimally manipulated unlicensed UCB units: * vital signs Monitoring during and after UCB infusion: * Management of infusion reactions * Post-transplant care and follow-up: will be done according to the disease specific treatment protocol and institutional guidelines. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Exclusion criteria are specified in the treatment protocol according to indication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Umbilical Cord Blood (UCB)Infusion of Minimally Manipulated UCB Units - the UCB unit will be infused through a central line according to institutional guidelines. | Biological | Unlicensed Umbilical Cord Blood Infusion |
Primary outcome
Incidence of Blood Borne Pathogen Transmission from Unlicensed UCB Units.
Time frame: Within 24 Hours Post Infusion
Documentation of events for the purpose of this study will only be for those events at least possibly related to the unlicensed UCB. Monitoring for acute infusional toxicities will end 24 hours after the umbilical cord blood (UCB) infusion.
4 secondary outcomes
Incidence of Serious Infusion Reactions of Minimally Manipulated Unlicensed UCB Units
Time frame: Up to Day 180
Number of the Desired Lineage Specific Cells in Minimally Manipulated Unlicensed UCB Units
Time frame: Prior to Infusion
Incidence of Mislabeled UCB Units
Time frame: Up to Day 180
Comparison of Specific Cord Blood Banks (CBBs)
Time frame: Up to Day 180
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Masonic Cancer Center, University of Minnesota
Minneapolis, United States
Alex Hoover, MD, MSc principal investigator
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Umbilical Cord Blood (UCB) in people with Lymphatic Diseases and Hematopoietic Malignancy, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Blood Borne Pathogen Transmission from Unlicensed UCB Units. (time frame: Within 24 Hours Post Infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.