Case Report

First Case of Severe Pain and Inflammation Reduction by Application of Purified Amniotic Fluid on Active Lesions of a Patient with Pyoderma Gangrenosum

by Pascal J Goldschmidt-Clermont1*, Kenda Plasencia2, Alexander JP Goldschmidt1, Ian A White1

1Neobiosis LLC, UF Sid Martin Innovate Biotechnology Institute, Alachua, FL 32615, USA

2Department of Nursing, Baptist Hospital, Baptist Health South Florida, FL 33176, USA

*Corresponding author: Pascal J Goldschmidt-Clermont, Neobiosis LLC, UF Sid Martin Innovate Biotechnology Institute, Alachua, FL 32615, USA.

Received Date: 19 December 2023

Accepted Date: 22 December 2023

Published Date: 26 December 2023

Citation: Goldschmidt-Clermont PJ, Plasencia K, Goldschmidt AJP, White IA (2023) First Case of Severe Pain and Inflammation Reduction by Application of Purified Amniotic Fluid on Active Lesions of a Patient with Pyoderma Gangrenosum. Ann Case Report 08: 1566. https://doi.org/10.29011/2574-7754.101566

Abstract

We report the first case of severe pain and inflammation reduction by application of purified amniotic fluid on active lesions of a patient with pyoderma gangrenosum. We describe the impact of every third-day skin applications of a sterile fraction (4ml) from human purified amniotic fluid (ViX001) obtained from thoroughly screened volunteers at the time of planned c-section at the term of normal pregnancies. The product ViX001 was generated through a proprietary process and kept in frozen one or two milliliters cryovials (protein content was ~1mg/ml) and thawed just prior to applications. Pain improvement was recorded after each application, and inflammation suppression was confirmed by serial pictures of the lesions. While our findings need to be reproduced with a larger cohort of patients, preferably at an earlier stage of the disease, it is instructive that ViX001 reduced severe pain and inflammation for a patient with advanced pyoderma gangrenosum. Pyoderma gangrenosum is a dreadful skin condition consisting of noninfectious neutrophilic dermatosis that progresses to necrotic ulcers with a characteristic purple edge and extremely painful raw subdermal tissue exposure.

Keywords: Purified Amniotic Fluid; Perinatal Products; Pyoderma Gangrenosum; Inflammation, Extracellular Vesicles; Exosomes; Healing; Tissue Repair, Regenerative Medicine, Immunity.

Introduction

Pyoderma Gangrenosum (PG) is a noninfectious neutrophilic dermatosis which starts with a painful nodule or pustule that progresses to necrotic ulcers with a characteristic purple edge, usually located on lower limbs [1]. Pain associated with the ulcer lesions is excruciating and responds poorly to standard therapy. PG is a diagnosis of exclusion based on clinical and histological features. Up to 50% of the cases are associated with systemic disease, particularly inflammatory bowel disease (Crohn’s and ulcerative colitis). Early lesions show neutrophilic folliculitis, and perifollicular inflammation with a dermal abscess, which may resemble a spider bite (a red bump).

PG is a rare disease, about 2,200 cases are diagnosed per year in the US. It affects women and men equally and is more frequent in individuals 50-70 years old. PG is an inflammatory skin disease of unknown etiology, although approximately 25% of PG cases are caused by a limited injury or an external stimulus [2]. PG rapidly progresses after its onset and is classified into five types: ulcerative type (most frequent), bullous type, pustular type, vegetative type, and a type that develops around a stoma [3]. In ulcerative PG, the lesions expand to form raised ulcers with infiltration of their purple margins [4]. These ulcerations cause severe deterioration in patients’ quality of life [5].

Case Presentation

The patient was a 78-year-old gentleman who had a complicated cardiovascular history with atrial fibrillation, blood clot in the right atrium, status post watchman device placement in left atrial appendage, pacemaker placement. He also had severe peripheral vascular disease, with left calf arterial occlusion and arterial thrombectomy. Further evidence of his thromboembolic proclivity was a history of deep vein thrombosis of the left leg complicated by saddle pulmonary embolism. He was treated with Eliquis to control his thrombotic diathesis. He also had severe coronary artery disease with a history of myocardial infarction, placement of five stents, two in his left anterior descending, and three in his circumflex, coronaries. He did have hypercholesterolemia and was treated for it with Evolocumab injections.

The patient had non-cardiovascular issues, including colon diverticulitis, status post-resection, and cholecystectomy. He had history of sleep apnea treated with Bipap device at night. He also demonstrated advanced signs of Alzheimer’s disease when he developed Pyoderma Gangrenosum (PG). At that time, he did not have history of inflammatory bowel disease like Crohn’s or ulcerative colitis. The patient received debridement of his left lower extremity to remove necrotic tissues. Right after the surgery to remove necrotic tissues, the lesions accelerated and began to spread. In a few weeks, the patient evolved from having what looked like a “spider bite” to severe and deep ulcers of his left leg below the knee, and one milder lesion behind his right calf. The lesions were treated by covering them with Systagenix Adaptic Non-Adhering Sterile Dressing 5”x9”. He was receiving acetaminophen, tramadol, Percocet and Oxycontin for pain.

In late December the patient developed bright red rectal bleeding, his hemoglobin decreased from 15.1 g/dL to 12.1 g/dL. Urgent endoscopy and colonoscopy were performed. The colonoscopy did not reveal any inflammatory bowel disease. However, the upper endoscopy revealed three large bleeding ulcers in the antrum of his stomach. He was prescribed Dexilant, Carafate, and Pepcid.

In January 2023, we learned about the patient while he was in the hospital for the management of excruciating pain resulting from ulcers of his left leg, which were deep enough to expose the muscle layers, and the largest one covered an area of 15 x 7 centimeters. Because this was the single largest lesion of PG for the patient, it was the one illustrated by serial pictures (Figure 1). The patient was unable to leave the hospital because his pain was 10/10 and unmanageable at home.