Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 345 for:    cord blood | Recruiting, Not yet recruiting, Available Studies

Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01451502
Recruitment Status : Recruiting
First Posted : October 13, 2011
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

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.

Condition or disease Intervention/treatment Phase
Lymphatic Diseases Hematopoietic Malignancy Biological: Umbilical Cord Blood (UCB) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units
Actual Study Start Date : October 20, 2011
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Incidence of Blood Borne Pathogen Transmission from Unlicensed UCB Units. [ Time Frame: Within 24 Hours Post Infusion ]
    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 :
  1. Incidence of Serious Infusion Reactions of Minimally Manipulated Unlicensed UCB Units [ Time Frame: Up to Day 180 ]
  2. Number of the Desired Lineage Specific Cells in Minimally Manipulated Unlicensed UCB Units [ Time Frame: Prior to Infusion ]
    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).

  3. Incidence of Mislabeled UCB Units [ Time Frame: Up to Day 180 ]
  4. Comparison of Specific Cord Blood Banks (CBBs) [ Time Frame: Up to Day 180 ]
    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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01451502


Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Claudio Brunstein, MD Masonic Cancer Center, University of Minnesota

Layout table for additonal information
Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT01451502     History of Changes
Other Study ID Numbers: 2011LS079
MT2011-13R ( Other Identifier: Blood and Marrow Transplantation Program )
First Posted: October 13, 2011    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019

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

Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphatic Diseases
Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Hematologic Diseases