Stem Cells After Peripheral Mobilization and Harvest

Completed · Phase 1

Conditions studied: Stem Cells, Orthopedic Disorder

In brief

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.

Key facts

Study ID

NCT03381599

Run by

Andrews Research & Education Foundation

People needed

10

Starts

2018-03-28

Expected to finish

2019-09-04

Last updated by the study team

2020-03-06

Who can join

Age: 19 and older, up to 39. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Weight 110-220 pounds
• Healthy

You may not qualify if…

• Previous allergic reaction to Filgrastim, lidocaine, or other injectable numbing agent
• White blood count greater than 20,000/mcL
• Latex allergy
• Diabetes
• Any autoimmune disorder
• Any blood disorder requiring immunosuppression
• Cancer
• Ongoing infectious disease
• Significant cardiovascular, renal, hepatic, or pulmonary disease
• Sickle cell or other blood disorders
• Presence of abdominal tenderness with palpation upon physical examination
• Signs of splenomegaly upon physical examination
• Abnormal lung fields upon physical examination

Where it is running

• Auburn University — Auburn, Alabama, United States

Full record on ClinicalTrials.gov

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