Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00082329
Recruitment Status : Completed
First Posted : May 6, 2004
Results First Posted : May 2, 2014
Last Update Posted : May 2, 2014
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Richard Childs, M.D., National Heart, Lung, and Blood Institute (NHLBI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy
Intervention Drug: AMD 3100 (Mozobil plerixafor)
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AMD 3100 (Mozobil Plerixafor)
Hide Arm/Group Description 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
Period Title: Overall Study
Started 9
Completed 9
Not Completed 0
Arm/Group Title AMD 3100 (Mozobil Plerixafor)
Hide Arm/Group Description

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

Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
<=18 years
0
   0.0%
Between 18 and 65 years
9
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
3
  33.3%
Male
6
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants
9
1.Primary Outcome
Title 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.
Hide Description

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

We propose that the combination of single dose AMD 3100 and G-CSF as combined mobilizing agents will improve the peripheral blood progenitor cells mobilization as compared to G-CSF mobilization. The successful treatment responders will complete study treatment with cell mobilization and cell collection. Non-responders will have completed the study treatment and have cell mobilization without cell collection.

Time Frame Day 1 (cells are counted 24 hours after AMD3100)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AMD 3100 and G-CSF Responders
Hide Arm/Group Description:

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

We propose that the combination of single dose AMD 3100 and G-CSF as combined mobilizing agents will improve the peripheral blood progenitor cells mobilization as compared to G-CSF mobilization.

Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: participants
AMD & G-CSF Responder 8
AMD& G-CSF Non-Responder 1
2.Secondary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame Through day 7
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AMD 3100 & G-CSF Respnders
Hide Arm/Group Description

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

We propose that the combination of single dose AMD 3100 and G-CSF as combined mobilizing agents will improve the peripheral blood progenitor cells mobilization as compared to G-CSF mobilization.

All-Cause Mortality
AMD 3100 & G-CSF Respnders
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
AMD 3100 & G-CSF Respnders
Affected / at Risk (%)
Total   1/9 (11.11%) 
Vascular disorders   
deep vein thromboisi *  1/9 (11.11%) 
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
AMD 3100 & G-CSF Respnders
Affected / at Risk (%)
Total   8/9 (88.89%) 
Blood and lymphatic system disorders   
Elevated Alk Phos *  8/9 (88.89%) 
Elevated LDH *  8/9 (88.89%) 
Elevated WBCs *  1/9 (11.11%) 
Cardiac disorders   
tachycardia *  1/9 (11.11%) 
Gastrointestinal disorders   
Diarrhea *  4/9 (44.44%) 
General disorders   
achy *  1/9 (11.11%) 
Appetite decr'd *  1/9 (11.11%) 
Body ache *  1/9 (11.11%) 
diaphoresis *  1/9 (11.11%) 
fatigue *  3/9 (33.33%) 
Headache *  3/9 (33.33%) 
low back pain *  1/9 (11.11%) 
Tiredness *  1/9 (11.11%) 
Tiredness (fatigue) *  4/9 (44.44%) 
Musculoskeletal and connective tissue disorders   
Back pain *  1/9 (11.11%) 
bone pain *  3/9 (33.33%) 
low back pain *  1/9 (11.11%) 
Muscle pain *  1/9 (11.11%) 
Nervous system disorders   
paresthia (facial tingling) *  1/9 (11.11%) 
Psychiatric disorders   
Mood alteration *  1/9 (11.11%) 
Skin and subcutaneous tissue disorders   
Bruising, local at IV site *  1/9 (11.11%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Richard Childs
Organization: NHLBI NIH
Phone: 301-594-8008
EMail: childsr@nhlbi.nih.gov
Layout table for additonal information
Responsible Party: Richard Childs, M.D., National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00082329    
Other Study ID Numbers: 040179
04-H-0179 ( Other Identifier: NIH NHLBI )
First Submitted: May 6, 2004
First Posted: May 6, 2004
Results First Submitted: April 1, 2014
Results First Posted: May 2, 2014
Last Update Posted: May 2, 2014