Injection of an Autologous A2M Concentrate Alleviates Back Pain in FAC-positive Patients

NCT03307876 | Completed

• 1 other identifier: 201601
• Study Type: observational
• Target: 24
• Locations: 0 countries
• Sites: N/A

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 the G3 domain of aggrecan, reducing the fibronectin-aggrecan G3 complex and therefore may be an efficacious treatment. The present study was designed to determine 1) the ability of autologous concentrated A2M to relieve back pain in patients with LBP from DDD and 2) the ability of FAC to predict the response to this biologic therapy. 24 patients with low back pain and MRI-concordant DDD had prospective evaluation. Oswestry disability index (ODI) and visual analog scores (VAS) were noted at baseline and at 3- and 6-month follow-up. Primary outcome of clinical improvement was defined as patients with both a decrease in VAS of at least 3 points and ODI \>20 points. Molecular discography and delayed FAC analysis and injection of platelet poor plasma at the time of the procedure. Patients with FACT-positive assays were significantly more likely to show improvement in their VAS and ODI at follow-up.

Conditions

Low Back Pain

Keywords

biologic,; Alpha 2 Macroglobulin; A2M; back pain; APIC; FAC; FACT

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index (ODI)

  Change from Baseline ODI at 3 and 6 months

  3 and 6 months

Secondary Outcomes (1)

• Visual Analogue Score (VAS)

  3 and 6 month

Study Arms (1)

groups that are fac + and -

autologous PPP injection is given to all patients. Prior to injection, a lavage of the disc space is taken to test for FAC.

Other: autologous PPP injection

Interventions

autologous PPP injection OTHER

autologous platelet poor plasma (PPP) injection taken from the participants own blood is injected in to all patients.

groups that are fac + and -

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with LBP

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Scuderi, Gaetano J., M.D.: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

lavage sample of the disc for FAC analysis is taken prior to autologous PPP injection. It was discarded after the analysis was complete.

MeSH Terms

Conditions

Low Back Pain; Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: October 12, 2017
• Study Start: April 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: October 12, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share