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

Low Back Pain Clinical Trial

Official title:

Intradiscal Injection of an Autologous Alpha-2-macroglobulin (A2M) Concentrate Alleviates Back Pain in FAC-positive Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03307876
• Other study ID #: 201601
• Status: Completed
• Phase: N/A
• First received: June 24, 2016
• Last updated: October 11, 2017
• Start date: April 2014
• Est. completion date: May 2015

Study information

• Verified date: October 2017
• Source: Scuderi, Gaetano J., M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 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 platelet poor plasma (PPP) with concentrated A2M to relieve back pain in patients with low back pain (LBP) from DDD and 2) the ability of FAC to predict the response to this biologic therapy.

Study design/setting: Prospective cohort

Patients: 24 patients with low back pain and MRI-concordant DDD

Methods: All patients underwent lavage for molecular discography and delayed FAC analysis and injection of autologous platelet poor plasma (PPP) rich in A2M (Cytonics Autologous Protease Inhibitor Concentrate, APIC) at the time of the procedure. ANOVA with Bonferonni correction for multiple comparisons was performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Scuderi, Gaetano J., M.D.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oswestry Disability Index (ODI)	Change from Baseline ODI at 3 and 6 months	3 and 6 months
Secondary	Visual Analogue Score (VAS)	Change from Baseline VAS at 3 and 6 months	3 and 6 month