Trial Outcomes & Findings for G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers (NCT NCT00082329)
NCT ID: NCT00082329
Last Updated: 2021-07-22
Results Overview
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. Successful treatment responders is defined by completing study treatment with cell mobilization and cell collection. Non-responders is defined by having completed the study treatment and having cell mobilization without cell collection.
COMPLETED
PHASE2
9 participants
Day 1 (cells are counted 24 hours after AMD3100)
2021-07-22
Participant Flow
Participant milestones
| Measure |
G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers
Participants received subcutaneous injection of granulocyte colony-stimulating factor (G-CSF) at 10 mcg/kg/day for 5 days followed by a single subcutaneous injection of AMD3100 (240 mcg/kg) given 12 hours prior to apheresis peripheral blood stem cell collection. Peripheral blood stem cell collection was performed on the fifth day following G-CSF administration.
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|---|---|
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Overall Study
STARTED
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9
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Overall Study
COMPLETED
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9
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers
n=9 Participants
Participants received subcutaneous injection of granulocyte colony-stimulating factor (G-CSF) at 10 mcg/kg/day for 5 days followed by a single subcutaneous injection of AMD3100 (240 mcg/kg) given 12 hours prior to apheresis peripheral blood stem cell collection. Peripheral blood stem cell collection was performed on the fifth day following G-CSF administration.
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Age, Categorical
<=18 years
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0 Participants
n=39 Participants
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Age, Categorical
Between 18 and 65 years
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9 Participants
n=39 Participants
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Age, Categorical
>=65 years
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0 Participants
n=39 Participants
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Sex: Female, Male
Female
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3 Participants
n=39 Participants
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Sex: Female, Male
Male
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6 Participants
n=39 Participants
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Region of Enrollment
United States
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9 participants
n=39 Participants
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PRIMARY outcome
Timeframe: Day 1 (cells are counted 24 hours after AMD3100)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. Successful treatment responders is defined by completing study treatment with cell mobilization and cell collection. Non-responders is defined by having completed the study treatment and having cell mobilization without cell collection.
Outcome measures
| Measure |
G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers
n=9 Participants
Participants received subcutaneous injection of granulocyte colony-stimulating factor (G-CSF) at 10 mcg/kg/day for 5 days followed by a single subcutaneous injection of AMD3100 (240 mcg/kg) given 12 hours prior to apheresis peripheral blood stem cell collection. Peripheral blood stem cell collection was performed on the fifth day following G-CSF administration.
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Number of Participants With Successful Apheresis Collection Following Combination of AMD3100 and G-CSF.
AMD & G-CSF Responder
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8 participants
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Number of Participants With Successful Apheresis Collection Following Combination of AMD3100 and G-CSF.
AMD& G-CSF Non-Responder
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1 participants
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SECONDARY outcome
Timeframe: Day 7Average fold change from baseline of mobilized cells that contained immune properties and other cellular content following G-CSF and AMD3100 to mobilize stem cells in healthy volunteers. The mobilized cells are defined as: white blood cells, lymphocytes, polys and monocytes. Polys (also known as segs, segmented neutrophils, neutrophils, granulocytes) are the most numerous of our white blood cells.
Outcome measures
| Measure |
G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers
n=9 Participants
Participants received subcutaneous injection of granulocyte colony-stimulating factor (G-CSF) at 10 mcg/kg/day for 5 days followed by a single subcutaneous injection of AMD3100 (240 mcg/kg) given 12 hours prior to apheresis peripheral blood stem cell collection. Peripheral blood stem cell collection was performed on the fifth day following G-CSF administration.
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Average Fold Change From Baseline of Mobilized Cells Following G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers
White Blood Cells
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9.3 Mean Fold Change from Baseline
Interval 6.6 to 14.0
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Average Fold Change From Baseline of Mobilized Cells Following G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers
Lymphocytes
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3.8 Mean Fold Change from Baseline
Interval 2.4 to 5.3
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Average Fold Change From Baseline of Mobilized Cells Following G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers
Polys
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11.9 Mean Fold Change from Baseline
Interval 7.2 to 17.8
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Average Fold Change From Baseline of Mobilized Cells Following G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers
Monocytes
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6.6 Mean Fold Change from Baseline
Interval 2.2 to 12.2
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SECONDARY outcome
Timeframe: Day 7Population: 1 participant did not complete apheresis, therefore 1 participant was not included in analysis
Number of participants with increase in yields of hematopoietic progenitor cells, immune cells, and other cellular subsets collected by apheresis following G-CSF and AMD3100 to mobilize stem cells.
Outcome measures
| Measure |
G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers
n=9 Participants
Participants received subcutaneous injection of granulocyte colony-stimulating factor (G-CSF) at 10 mcg/kg/day for 5 days followed by a single subcutaneous injection of AMD3100 (240 mcg/kg) given 12 hours prior to apheresis peripheral blood stem cell collection. Peripheral blood stem cell collection was performed on the fifth day following G-CSF administration.
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Number of Participants With Increased the Levels of Circulating Hematopoietic Progenitor Cells, Immune Cells, and Other Cellular Subsets Collected by Apheresis.
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8 participants
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Adverse Events
G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers
Serious adverse events
| Measure |
G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers
n=9 participants at risk
Participants received subcutaneous injection of granulocyte colony-stimulating factor (G-CSF) at 10 mcg/kg/day for 5 days followed by a single subcutaneous injection of AMD3100 (240 mcg/kg) given 12 hours prior to apheresis peripheral blood stem cell collection. Peripheral blood stem cell collection was performed on the fifth day following G-CSF administration.
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Vascular disorders
deep vein thrombosis
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11.1%
1/9 • 30 days
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Other adverse events
| Measure |
G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers
n=9 participants at risk
Participants received subcutaneous injection of granulocyte colony-stimulating factor (G-CSF) at 10 mcg/kg/day for 5 days followed by a single subcutaneous injection of AMD3100 (240 mcg/kg) given 12 hours prior to apheresis peripheral blood stem cell collection. Peripheral blood stem cell collection was performed on the fifth day following G-CSF administration.
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Blood and lymphatic system disorders
Elevated Alk Phos
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88.9%
8/9 • 30 days
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Blood and lymphatic system disorders
Elevated LDH
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88.9%
8/9 • 30 days
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Blood and lymphatic system disorders
Elevated WBCs
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11.1%
1/9 • 30 days
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Cardiac disorders
tachycardia
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11.1%
1/9 • 30 days
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Gastrointestinal disorders
Diarrhea
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44.4%
4/9 • 30 days
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General disorders
achy
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11.1%
1/9 • 30 days
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General disorders
Appetite decr'd
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11.1%
1/9 • 30 days
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General disorders
Body ache
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11.1%
1/9 • 30 days
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General disorders
diaphoresis
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11.1%
1/9 • 30 days
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General disorders
fatigue
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33.3%
3/9 • 30 days
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General disorders
Headache
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33.3%
3/9 • 30 days
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General disorders
low back pain
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11.1%
1/9 • 30 days
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General disorders
Tiredness
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11.1%
1/9 • 30 days
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General disorders
Tiredness (fatigue)
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44.4%
4/9 • 30 days
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Musculoskeletal and connective tissue disorders
Back pain
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11.1%
1/9 • 30 days
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Musculoskeletal and connective tissue disorders
bone pain
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33.3%
3/9 • 30 days
|
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Musculoskeletal and connective tissue disorders
low back pain
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11.1%
1/9 • 30 days
|
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Musculoskeletal and connective tissue disorders
Muscle pain
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11.1%
1/9 • 30 days
|
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Nervous system disorders
paresthia (facial tingling)
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11.1%
1/9 • 30 days
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Psychiatric disorders
Mood alteration
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11.1%
1/9 • 30 days
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Skin and subcutaneous tissue disorders
Bruising, local at IV site
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11.1%
1/9 • 30 days
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place