Recruiting

Umbilical Cord Blood

Sponsor:

Masonic Cancer Center, University of Minnesota

Code:

NCT01451502

Conditions

Lymphatic Diseases

Hematopoietic Malignancy

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Umbilical Cord Blood (UCB)

Study Details

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.

Conditions

Lymphatic Diseases

Hematopoietic Malignancy

Study ID

NCT01451502

Start date

Oct 20, 2011

Status verified date

Oct, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

250 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Unlicensed Umbilical Cord Blood Infusion

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.

Interventions

Umbilical Cord Blood (UCB)

Infusion of Minimally Manipulated UCB Units - the UCB unit will be infused through a central line according to institutional guidelines.

Primary outcome measure

  • Incidence of Blood Borne Pathogen Transmission from Unlicensed UCB Units. [ Time Frame: Within 24 Hours Post Infusion ]

Central Contacts and Locations

Locations

Masonic Cancer Center, University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Claudio Brunstein, MD

612-625-3918bruns072@umn.edu

Principal Investigator:

Claudio Brunstein, MD

More Information

Sponsor

Masonic Cancer Center, University of Minnesota

Last update posted

Oct 6, 2026

Last verified

Oct, 2026

Keywords

  • umbilical cord blood

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-22. This information was provided to ClinicalTrials.gov by Masonic Cancer Center, University of Minnesota on 2026-10-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.