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

NCT04066933 | Unknown

• 1 other identifier: 33237/1
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Alpha 2 macroglobulin

Outcome Measures

Primary Outcomes (2)

• Brief Pain Inventory (BPI)

  Self-report measure containing a composite pain score and functional interference score. The pain subscale contains 4 questions, each with answers ranging from 0 'no pain' to 10 'pain as bad as you can imagine.' Total possible score for the pain subscale is 40 points. The functional/interference subscale contains 7 questions, with each answer ranging from 0 'does not interfere' to 10 'completely interferes.' The maximum possible score for the interference subscale is 70 points. The total overall composite BPI score is out of 100 maximum points.

  Baseline

• Patient Global Impression of Change Scale (PGIC)

  Qualitative assessment of meaningful change obtained by a brief interview to estimate patients' overall perceived benefit of study procedures. The PGIC is structured as a 7-item scale ranging from 1 'very much improved' to 7 'very much worse.' Scores of 1 and 2 reflected notable subjective perception of benefit.

  3 months

Secondary Outcomes (3)

• Brief Pain Inventory (BPI)

  1 month

• Brief Pain Inventory (BPI)

  3 months

• Brief Pain Inventory (BPI)

  6 months

Other Outcomes (1)

• Adverse Event (AE) and Serious Adverse Event (SAE) Reporting

  Reported throughout study duration, up to 12 months

Interventions

A2M enriched plasma COMBINATION_PRODUCT

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).

Also known as: A2M-PPP

Eligibility Criteria

• Age: 23 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

56 patients (43 women, 13 men) with an age range of 23 to 77 years old who had undergone the outlined procedure were included in this chart review.

Inclusionary Criteria: * All patients had daily disabling cervical brachial pain that was continuously present for at least six months. * After examination by one or both of the authors, patients who were diagnosed as having a condition related to musculotendinous pain (MTPS), neuropathic Thoracic Outlet Syndrome (NTOS), or Complex Regional Pain Syndrome (CRPS) qualified for treatment and inclusion in the chart review. Exclusionary Criteria: * N/A * (retrospective analysis of clinical treatment)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Neurological Associates of West Los Angeles: lead

Study Sites (1)

Neurological Associates of West Los Angeles

Santa Monica, California, 90403, United States

Location

Related Publications (16)

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  BACKGROUND

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  PMID: 17629925 RESULT

MeSH Terms

Conditions

Complex Regional Pain Syndromes; Neuralgia; Thoracic Outlet Syndrome

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nerve Compression Syndromes; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sheldon Jordan, MD, FAAN

  Neurological Associates of West Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 26, 2019
• Study Start: September 24, 2018
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 28, 2022

Record last verified: 2022-09

Locations

US (1)