Status:
COMPLETED
Injection of an Autologous A2M Concentrate Alleviates Back Pain in FAC-positive Patients
Lead Sponsor:
Scuderi, Gaetano J., M.D.
Conditions:
Low Back Pain
Eligibility:
All Genders
18-65 years
Brief Summary
A cartilage degradation product, the Fibronectin-Aggrecan complex (FAC), has been identified in patients with degenerative disc disease (DDD). Alpha-2-macroglobulin (A2M) can prevent the formation of ...
Detailed Description
Objectives: A cartilage degradation product, the Fibronectin-Aggrecan complex (FAC), has been identified in patients with degenerative disc disease (DDD). Alpha-2-macroglobulin (A2M) can prevent the f...
Eligibility Criteria
Inclusion
- 18 years of age or greater with a history of low back pain complaints primarily dictated by pain with associated sensory symptoms and/or low back pain for 6 months or more who had failed expectant management with NSAIDS, activity modification, and/or physical therapy.
- MRI that demonstrated signs of degenerative disc disease at one or more levels with a Pfirrmann grade of II to IV.
- Age from 18 to 65 with axial back pain of at least 6 months duration.
Exclusion
- Patients with a history of oral or injected corticosteroid medication within a three month period prior to disc injection.
- Chronic medical conditions associated with metabolic or inflammatory disorders (insulin-dependent diabetes mellitus, severe coronary artery disease, rheumatic or autoimmune diseases) were excluded from the study.
Key Trial Info
Start Date :
April 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03307876
Start Date
April 1 2014
End Date
May 1 2015
Last Update
October 12 2017
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