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G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Richard Childs, M.D., National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00082329
First received: May 6, 2004
Last updated: April 1, 2014
Last verified: April 2014
Results First Received: April 1, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Healthy
Intervention: Drug: AMD 3100 (Mozobil plerixafor)

  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
No text entered.

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
AMD 3100 (Mozobil Plerixafor) Healthy volunteers will be administered AMD 3100 (Mozobil plerixafor) and granulocyte colony stimulating factor (G-CSF) to determine cytokine polarization status of cluster of differentiation (CD 4) T-cells collected by apheresis

Participant Flow:   Overall Study
    AMD 3100 (Mozobil Plerixafor)  
STARTED     9  
COMPLETED     9  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
AMD 3100 (Mozobil Plerixafor)

Healthy volunteers will be administered AMD 3100 (Mozobil plerixafor) and granulocyte colony stimulating factor (G-CSF) to determine cytokine polarization status of cluster of differentiation (CD 4) T-cells collected by apheresis

AMD 3100 (Mozobil plerixafor) : Healthy volunteers will be administered AMD 3100 (Mozobil plerixafor) and granulocyte colony stimulating factor (G-CSF) to determine cytokine polarization status of cluster of differentiation (CD 4) T-cells collected by apheresis


Baseline Measures
    AMD 3100 (Mozobil Plerixafor)  
Number of Participants  
[units: participants]
  9  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     9  
>=65 years     0  
Gender  
[units: participants]
 
Female     3  
Male     6  
Region of Enrollment  
[units: participants]
 
United States     9  



  Outcome Measures

1.  Primary:   To Determine the Cytokine Polarization Status of Cluster of Differentiation 4 (CD4)+ T-cells Collected by Apheresis Following Combination of AMD3100 and G-CSF Compared to G-CSF Mobilization.   [ Time Frame: Day 1 (cells are counted 24 hours after AMD3100) ]

2.  Secondary:   To Examine 1) the Cellular Content and Other Immune Properties of Mobilized Cells; 2) Yields of Hematopoietic Progenitor Cells, Immune Cells, and Other Cellular Subsets Collected by Apheresis; and 3) Safety Profile of AMD3100.   [ Time Frame: Through day 7 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Richard Childs
Organization: NHLBI NIH
phone: 301-594-8008
e-mail: childsr@nhlbi.nih.gov


Publications:

Responsible Party: Richard Childs, M.D., National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00082329     History of Changes
Other Study ID Numbers: 040179, 04-H-0179
Study First Received: May 6, 2004
Results First Received: April 1, 2014
Last Updated: April 1, 2014
Health Authority: United States: Food and Drug Administration