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

NCT04066933 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2022-09-28

No results posted yet for this study

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.

Conditions

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

Interventions

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).

Sponsors & Collaborators

  • Neurological Associates of West Los Angeles

    lead OTHER

Principal Investigators

  • Sheldon Jordan, MD, FAAN · Neurological Associates of West Los Angeles

Eligibility

Min Age
23 Years
Max Age
77 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-24
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04066933 on ClinicalTrials.gov