The Striking Power of Amniotic Fluid and Its Exosomes Collected at the End of a Normal Pregnancy on Severe Inflammation and Tissue Repair

Abstract

With this short communication, which contains a new case report on diabetic ulcer, we summarize our research progress in treating several complex conditions at a point where currently available treatments were failing to help the affected patients. We review the first case of lower back pain due to severe spondylitis (T12-L1) treated with intravenous injections of a sterile fraction of human purified amniotic fluid (ViX001) obtained from thoroughly screened volunteers at the time of planned c-section at the term of normal pregnancies. Then, we review the first case of recalcitrant diabetic ulcer treated successfully by twice-daily applications of ViX001 directly on the wound and describe another case of diabetic ulcer treated successfully with ViX001. Next, we review the treatment of severe burns with direct application of ViX001 on the burns leading to accelerated improvement of the burn lesions. Finally, we review the first treatment of a patient with advanced pyoderma gangrenosum with ViX001, with significant reduction of pain, inflammation, and observation of tissue regeneration. We conclude our review with speculations on the mechanism of action of ViX001, the importance of extracellular vesicles in the amniotic fluid for its biological activity, and the need for expanding our studies to generate a better understanding of the omics signature of this incredibly beneficial material.

Keywords: Burns; Diabetic Foot Ulcer; Diabetic Wound; Exosomes; Extracellular Vesicles; Inflammation; Low Back Pain; Neoangiogenesis; Purified Amniotic Fluid; Pyoderma Gangrenosum; Regenerative Medicine; Spondylitis; Therapy; Tissue Repair; ViX001; Wound Healing.

Figure 1:

Evolution of the diabetic ulcer for our case report with every other day applications of an aseptic fraction of our human purified amniotic fluid product, ViX001. The upper left picture shows the wound after three months of standard treatment that did not promote healing of the ulcer. The next picture is 19 days later, the day of the first application of ViX001 (200 microliters) showing that if anything, the crater had further enlarged. The next six pictures show the progressive shrinking of the ulcer, which is filling with cells fed by capillaries indicating skin regeneration and contraction of the wound. After 76 days of treatment (11 weeks) the wound had closed, and treatment was discontinued. The last picture obtained two months after treatment discontinuation shows further progression of the skin healing.