Clinical trial NCT03307876: Injection of an Autologous A2M Concentrate Alleviates Back Pain in FAC-positive Patients
Official title: Intradiscal Injection of an Autologous Alpha-2-macroglobulin (A2M) Concentrate Alleviates Back Pain in FAC-positive Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Keywords: biologic,
Alpha 2 Macroglobulin
A2M
back pain
APIC
FAC
FACT
Lead sponsor: Scuderi, Gaetano J., M.D.
Sponsor class: OTHER
First posted: 2017-10-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with LBP

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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: 3 and 6 months
Secondary outcomes:
measure: Visual Analogue Score (VAS)
timeFrame: 3 and 6 month
Other outcomes:
Locations:
Study officials:
References: