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NCT02322151 · ClinicalTrials.gov registry record

Pharmacokinetics of Granulocyte Colony Stimulating Factor in the Breast Milk of Volunteer Peripheral Blood Stem Cell Donor

A clinical trial, sponsored by National Institutes of Health Clinical Center (CC).

Completed
Registry status
4
Enrollment target

NCT02322151: Completed study, sponsored by National Institutes of Health Clinical Center (CC).

NCT02322151 is a clinical trial that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 4 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02322151 has completed, sponsored by National Institutes of Health Clinical Center (CC).

COMPLETED
Registry status
4 participants
Enrollment target

Study Summary

Background: \- The drug filgrastim (rGCSF) increases the number of blood-forming cells in the bloodstream. These cells can be collected from donors bloodstreams and used for transplant. Studies have shown that rGCSF is present in the breast milk of nursing mothers who are taking it. Based on these studies, it is now recommended that a nursing mother should not breastfeed from the time she receives the first dose of the drug until 2 days after the final dose. Researchers want to study the amount of the drug and its effect on the cells present in donor blood and breast milk. They hope to better understand the effects of this drug on breast milk. Objectives: \- To understand the effects of filgrastim on breast milk. Eligibility: \- Women enrolled in NIH protocol 00-CC-0165 and currently breastfeeding. Design: * Participants will receive rGCSF daily for 5 days. They will have blood taken daily. * Participants will get a freezer bag containing 10 sterile, labeled containers for breast milk collection. * Participants will transfer some of the breast milk they pump into one of the containers. They will write the date and time the milk was collected on the container. They will freeze the samples. Any remaining milk should be disposed of. * Participants will bring the samples to NIH on the day of their stem cell collection procedure. * For days 1 and 2 after stem cell collection, participants will continue to collect and freeze breast milk samples and dispose of any remaining milk. * For days 3 5 after stem cell collection, participants will collect and freeze samples. They can also resume normal breastfeeding. * A research nurse will arrange to collect the samples.

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2014-12-12
Est. Completion 2016-10-14

What the finished NCT02322151 record still lists

NCT02322151 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 4 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT02322151 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02322151 about?

NCT02322151 is a clinical study titled "Pharmacokinetics of Granulocyte Colony Stimulating Factor in the Breast Milk of Volunteer Peripheral Blood Stem Cell Donor". Background: \- The drug filgrastim (rGCSF) increases the number of blood-forming cells in the bloodstream. These cells can be collected from donors bloodstreams and used for transplant. Studies have shown that rGCSF is present in the breast milk of nursing mothers who are taking it. Based on these ...

What is the current status of trial NCT02322151?

This trial is currently completed. The enrollment target is 4 participants. The study started on 2014-12-12. Estimated completion is 2016-10-14.

Who is sponsoring clinical trial NCT02322151?

This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT02322151, the US trial registry maintained by the National Library of Medicine. NCT02322151 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.