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Stem Cells After Peripheral Mobilization and Harvest

NCT03381599 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-03-06

No results posted yet for this study

Summary

The proposed study is a controlled laboratory study where stem cell content of bone marrow aspirate will be compared prior to and following pharmaceutical mobilization. Participants who meet the inclusion/exclusion criteria will have a bone marrow sample taken from the iliac crest. The sample will be tested to determine stem cell content and for the presence of proteins which are of interest in orthopedic treatments. Thirty days following the baseline bone marrow collection, participants will receive a subcutaneous injection of Filgrastim daily for four serial days. On the fifth day, a peripheral blood sample will be taken and processed.

Conditions

  • Stem Cells
  • Orthopedic Disorder

Interventions

DRUG

Filgrastim Injection

Filgrastim of 10 ug/kg/day will be given for four serial days.

Sponsors & Collaborators

  • Auburn University

    collaborator OTHER

  • Arthrex, Inc.

    collaborator INDUSTRY

  • Andrews Research & Education Foundation

    lead OTHER

Principal Investigators

  • Adam W Anz, MD · Andrews Research & Education Foundation

  • Michael Goodlett, MD · Auburn University

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
39 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-28
Primary Completion
2019-09-04
Completion
2019-09-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03381599 on ClinicalTrials.gov