NCT01451502

Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
BIOLOGICAL	Umbilical Cord Blood (UCB)	Infusion of Minimally Manipulated UCB Units - the UCB unit will be infused through a central line according to institutional guidelines.

Timeline

• Start date: 2011-10-20
• Primary completion: 2026-04-01
• Completion: 2026-12-01
• First posted: 2011-10-13
• Last updated: 2025-12-18

Locations

1 site across 1 country: United States