Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Masonic Cancer Center, University of Minnesota
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT01451502
First received: October 11, 2011
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Lymphatic Diseases
Hematopoietic Malignancy
Biological: Umbilical Cord Blood (UCB)

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units

Resource links provided by NLM:


Further study details as provided by Masonic Cancer Center, University of Minnesota:

Primary Outcome Measures:
  • Incidence of Blood Borne Pathogen Transmission from Unlicensed UCB Units. [ Time Frame: Within 24 Hours Post Infusion ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Incidence of Serious Infusion Reactions of Minimally Manipulated Unlicensed UCB Units [ Time Frame: Up to Day 180 ] [ Designated as safety issue: Yes ]
  • Number of the Desired Lineage Specific Cells in Minimally Manipulated Unlicensed UCB Units [ Time Frame: Prior to Infusion ] [ Designated as safety issue: Yes ]
    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).

  • Incidence of Mislabeled UCB Units [ Time Frame: Up to Day 180 ] [ Designated as safety issue: Yes ]
  • Comparison of Specific Cord Blood Banks (CBBs) [ Time Frame: Up to Day 180 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 250
Study Start Date: October 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01451502

Locations
United States, Minnesota
Masonic Cancer Center, University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Claudio Brunstein, MD    612-625-3918    bruns072@umn.edu   
Principal Investigator: Claudio Brunstein, MD         
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Principal Investigator: Claudio Brunstein, MD Masonic Cancer Center, University of Minnesota
  More Information

No publications provided

Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT01451502     History of Changes
Other Study ID Numbers: 2011LS079, MT2011-13R
Study First Received: October 11, 2011
Last Updated: May 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Masonic Cancer Center, University of Minnesota:
umbilical cord blood

Additional relevant MeSH terms:
Lymphatic Diseases
Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Hematologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014