Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Masonic Cancer Center, University of Minnesota
Study ID
NCT01451502
Status
Recruiting
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Conditions

  • Hematopoietic Malignancy
  • Lymphatic Diseases

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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 Details

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.

Key Dates

Start date
Oct 20, 2011
Status verified
May 2026
Primary completion
Sep 30, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
250 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

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.

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
Masonic Cancer Center, University of MinnesotaMinneapolisMinnesota55455
Claudio Brunstein, MD
[email protected]
612-625-3918
Claudio Brunstein, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Masonic Cancer Center, University of Minnesota· Minneapolis, MN

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