Orthopedic Disorder Clinical Trial
Official title:
Quantification and Qualification of Stem Cells After Peripheral Mobilization and Harvest for Orthopaedic Point of Care Application
Verified date | March 2020 |
Source | Andrews Research & Education Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | September 4, 2019 |
Est. primary completion date | September 4, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 19 Years to 39 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Auburn University | Auburn | Alabama |
Lead Sponsor | Collaborator |
---|---|
Andrews Research & Education Foundation | Arthrex, Inc., Auburn University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Stem Cell Count | Quantity and quality of the harvested stem cells | Baseline to Day 32 | |
Secondary | Complete blood count | Participants white blood cell count/differential | Day 1, Day 2, Day 28, Day 29, Day 30, Day 31 Day 32 | |
Secondary | Chemokine/Cytokine | Participants chemokine/cytokine count | Day 1, Day 2, Day 28, Day 29, Day 30, Day 31 Day 32 |
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