Stem Cells After Peripheral Mobilization and Harvest

• Status: Completed
• Trial end date: 2019-09-04
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Andrews Research & Education Foundation
• Collaborators: Arthrex, Inc.; Auburn University
• Treatments: Lenograstim

Criteria

Inclusion Criteria:

• Weight 110-220 pounds

• Healthy

Exclusion Criteria:

• 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