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Evaluation of the Spectra Optia® Apheresis System Mononuclear Cell (MNC) Collection Procedure in Healthy Blood Donors

This study has been completed.
Sponsor:
Collaborators:
Blood Center of Wisconsin
Key Biologics, LLC
LeukoLab
Yale University
Information provided by (Responsible Party):
Terumo BCT
ClinicalTrials.gov Identifier:
NCT01277549
First received: January 13, 2011
Last updated: May 2, 2013
Last verified: May 2013
History of Changes
Results First Received: September 11, 2012  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Leukapheresis
Intervention: Device: Mononuclear cell collection.

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Healthy adult donors were recruited at three blood collection centers to undergo a mononuclear cell collection using the experimental device, between January and September, 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
G-CSF Mobilized Donors In this arm the donors received G-CSF (granulocyte colony stimulating factor) prior to the MNC (mononuclear cell) collection. G-CSF causes the mobilization of hematopoetic stem cells which are CD34 (cluster of differentiation 34) + to the peripheral blood. Collection efficiency of all mononuclear cells and of the CD34+ subset of mononuclear cells was assessed.
Non-mobilized Donors In this arm, donors were not mobilized prior to mononuclear cell collection. Only collection efficiency of mononuclear cells could be assessed as CD34+ cells are not present in this population.

Participant Flow:   Overall Study
    G-CSF Mobilized Donors     Non-mobilized Donors  
STARTED     41     29  
COMPLETED     15     15  
NOT COMPLETED     26     14  
Failed to meet eligibility criteria                 13                 9  
Withdrawal by Subject                 1                 3  
Protocol Violation                 10                 1  
Physician Decision                 2                 1  



  Baseline Characteristics
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Reporting Groups
  Description
G-CSF Mobilized Donors Donors received G-CSF prior to MNC collection
Nonmobilized Donors Donors not mobilized prior to MNC collection
Total Total of all reporting groups

Baseline Measures
    G-CSF Mobilized Donors     Nonmobilized Donors     Total  
Number of Participants  
[units: participants]
 		  15     15     30  
Age [1]
[units: Years of Age]
Median ( Full Range ) 		  25  
  ( 19 to 45 )   		  33  
  ( 29 to 47 )   		  31  
  ( 19 to 47 )  
Gender  
[units: participants]
 		     
Female     3     4     7  
Male     12     11     23  
Region of Enrollment  
[units: participants]
 		     
United States     15     15     30  
[1] Median and range reported are for donors who completed the study.



  Outcome Measures
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1.  Primary:   Mononuclear Cell Collection Efficiency   [ Time Frame: One day ]
  Show Outcome Measure 1

2.  Primary:   CD34+ Cell Collection Efficiency   [ Time Frame: one day ]
  Show Outcome Measure 2

3.  Secondary:   Platelet Collection Efficiency   [ Time Frame: One Day ]
  Show Outcome Measure 3

4.  Secondary:   Hematocrit of MNC Product   [ Time Frame: One Day ]
  Show Outcome Measure 4

5.  Secondary:   Granulocyte % of MNC Product   [ Time Frame: One day ]
  Show Outcome Measure 5

6.  Secondary:   Viability of the Collected MNC Product   [ Time Frame: One day ]
  Show Outcome Measure 6


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Jerome R Bill, M.D.
Organization: Terumo BCT
phone: 303-231-4729
e-mail: jerry.bill@terumobct.com


No publications provided


Responsible Party: Terumo BCT
ClinicalTrials.gov Identifier: NCT01277549     History of Changes
Other Study ID Numbers: BCT10-03
Study First Received: January 13, 2011
Results First Received: September 11, 2012
Last Updated: May 2, 2013
Health Authority: United States: Food and Drug Administration