Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units

University of Minnesota (UMN)

Status: Enrolling

Conditions: Lymphatic Diseases; Hematopoietic Malignancy

Treatments: Biological: Umbilical Cord Blood (UCB)

Study type: Interventional

Funder types: Other

Identifiers

NCT01451502

MT2011-13R (Other Identifier)

2011LS079

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

Unlicensed Umbilical Cord Blood Infusion

Experimental group

Description:

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.

Treatment:

Biological: Umbilical Cord Blood (UCB)