Status:
COMPLETED
Stem Cells After Peripheral Mobilization and Harvest
Lead Sponsor:
Andrews Research & Education Foundation
Collaborating Sponsors:
Auburn University
Arthrex, Inc.
Conditions:
Stem Cells
Orthopedic Disorder
Eligibility:
MALE
19-39 years
Phase:
PHASE1
Brief 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 inclu...
Detailed Description
Orthopaedic practitioners have begun to augment surgical procedures and treat degenerative conditions, such as osteoarthritis, with injections of bone marrow aspirate. Clinical application studies hav...
Eligibility Criteria
Inclusion
- Weight 110-220 pounds
- Healthy
Exclusion
- 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
Key Trial Info
Start Date :
March 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 4 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03381599
Start Date
March 28 2018
End Date
September 4 2019
Last Update
March 6 2020
Active Locations (1)
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1
Auburn University
Auburn, Alabama, United States, 36849