First Case of Debilitating Lower Back Pain Induced by Severe Inflammation of Lumbar Joints, Healed by Intravenous Infusions of Purified Amniotic Fluid

Abstract

We report the first case of debilitating lower back pain induced by spondylitis with end plate inflammation of the lumbar spine, treated successfully by bi-weekly intravenous injections of a sterile fraction (1ml) from human purified amniotic fluid (ViX001) obtained from thoroughly screened volunteers at the time of planned c-section at the term of normal pregnancies. Our product ViX001 was generated through a proprietary process and kept in frozen one milliliter (1 ml) cryvials (protein content was ~1mg/ml) and thawed just prior to injections. Pain improvement was recorded weekly, and inflammation suppression was confirmed by monthly MRIs of the lumbar spine. While our findings need to be reproduced with a larger cohort of patients, it is instructive that ViX001 resolved pain and inflammation for a patient with severe lower back pain, the most common form of pain reported by U.S. adults.

Keywords: Back Pain; Exosomes; Extracellular Vesicles; Healing; Immunity; Inflammation; Perinatal Products; Purified Amniotic Fluid; Regenerative Medicine; Spine; Tissue Repair; Vertebral Disc.

Figure 1:

Magnetic Resonance Imaging (MRI) with Siemens Avanto 1.5 T instrument was used to study the lower spine of our patient before (left) and after (right) treatment with 24 biweekly intravenous infusions of ViX001, 1 ml dose for each infusion. Before treatment, the joints between vertebra T12-L1, and to a lesser degree L3-L4, show marked spondylitis with end plate inflammation (whiter area), which nearly resolved after treatment completion, and resolution of inflammation was associated with stabilization of the end plates on each side of the joints.