NCT04066933

Forms of Cervical Brachial Syndrome Treated With Plasma Concentrate Enriched for A2M

Neurogenic Thoracic Outlet Syndrome and Other Forms of Cervical Brachial Syndrome Treated With Plasma Concentrate Enriched for Alpha 2 Macroglobulin

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Neurological Associates of West Los Angeles · Academic / Other
• Sex: All
• Age: 23 Years – 77 Years
• Healthy volunteers: Not accepted

Summary

Alpha 2 macroglobulin (A2M) is a plasma protein that acts as a molecular trap for inflammatory factors such as tumor necrosis factor (TNF). After plasma is enriched for A2M, it may be injected for treating chronic inflammation. Plasma enriched for A2M may be considered as a possible injectable agent to counteract inflammation that may occur with a cervicobrachial pain syndrome. This study reports on an experiencing using A2M to treat cervicobrachial syndrome which was predominant for either musculotendinous or neuralgic features.

Detailed description

Regional pain in the neck, shoulder and arm is a common problem when there is exposure to repetitive work with a prevalence of about fifty percent. In the absence of a widespread pain conditions, and when cervical radiculopathy is ruled out with appropriate imaging, myalgia, tendinopathy or neurogenic sources of pain may predominate in a given case. Myalgia (MTPS) may be characterized by muscles that are tight and tender to palpation and where there may be radiation of pain down the limb. A twitch may be elicited with stimulation of affected muscle. Numerous treatments for myalgia have been proposed with variable or incomplete success including local anesthetic injections, botulinum chemodenervation and platelet rich plasma injections. Neuralgic complaints may be caused by chronic compression in the interscalene triangle as in Thoracic Outlet Syndrome (NTOS) and other patients may have injury from sudden stretch, electrocution, inflammatory diseases, penetrating wounds or acute or chronic post-operative conditions. Botulinum chemodenervation and surgical decompression has been applied for treating nerve compression due to Thoracic Outlet Syndrome with partial success. \[9-13\] Chemodenervation tends to be transient in effect and surgery may have significant complications. Previous reports have demonstrated relatively poor outcomes with targeted treatments when there is a coexistence of conditions characterized by increased sensitivity as in complex regional pain syndrome (CRPS) or fibromyalgia. In the present retrospective review, it was anticipated that patients with CRPS may not respond as well to targeted treatment so that they were evaluated separately from patients with NTOS along. Because existing therapies for myofascial and neuralgic forms of cervicobrachial pain may have unsatisfactory outcomes, alternative therapies may be considered, particularly, for individuals who have failed to respond. Contemporary conceptualizations of chronic pain mechanisms include the contribution of inflammatory factors. Mindful of these considerations, locally targeted anti-inflammatory administrations may be thought to play a potential role in treatment of cervicobrachial pain. Alpha 2 macroglobulin is a plasma protein that acts as a molecular trap for inflammatory factors such as tumor necrosis factor, TNF. After plasma is enriched for A2M, it may be injected for treating chronic inflammation. Plasma enriched for A2M may be considered as a possible injectable agent to counteract inflammation that may occur with a cervicobrachial pain syndrome. The present paper reports on an experience using A2M for treating cervicobrachial syndrome which was predominant for either musculotendinous or neuralgic features.

Conditions

• Complex Regional Pain Syndromes
• Neuralgia
• Thoracic Outlet Neurologic Syndrome

Interventions

Type	Name	Description
COMBINATION_PRODUCT	A2M enriched plasma	Plasma enriched for alpha2macroglobulin (A2M-PPP) was produced by a centrifugation and filtration process developed by Cytonics Corporation. Initially, 7 milliliters of Anticoagulant Citrate Dextrose Solution A, ubiquitous surface protein (USP) was drawn into a 60 cc syringe and then an additional 38 cc of autologous blood was drawn up through an antecubital vein. Two syringes were prepared in this manner and then centrifuged at 4000 rpm (1280G) for 4 minutes. The supernatant plasma fraction was then transferred to a roller pump system that circulates the fluid through a proprietary filter having a high molecular weight cutoff designed to trap larger molecules including alpha 2 macroglobulin (720 kDa).

Timeline

• Start date: 2018-09-24
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2019-08-26
• Last updated: 2022-09-28

Locations

1 site across 1 country: United States