Injection of an Autologous A2M Concentrate Alleviates Back Pain in

Status Completed

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03307876
Study type	Observational
Source	Scuderi, Gaetano J., M.D.
Contact
Status	Completed
Phase	N/A
Start date	April 2014
Completion date	May 2015

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms