Background: Autism spectrum disorders (ASD) are developmental disorders affecting 1:88 children, and which appear to be associated with a variety of complex immune dysregulations including autoimmunity. The enzyme, alpha-N-acetylgalactosaminidase (Nagalase) deglycosylates serum Gc protein (vitamin D3 – binding protein) rendering it incapable of activating macrophage defenses. Increased Nagalase activity has been associated with a variety of malignancies, immune disorders and viral infections. Macrophage activating factor (GcMAF) has been repeatedly published as an intervention to lower serum Nagalase activity for a variety of cancer and HIV patients. GcMAF is a naturally occurring protein with well-established safety and therapeutic benefit(s) supported by numerous human studies.
Methods: Initially, parents of 40 individuals with ASD sought testing for Nagalase serum activity as part of an evaluation of immune dysregulation. Nagalase enzyme activity measurement was performed by the European Laboratory of Nutrients (ELN), Bunnik, the Netherlands, using an end-point enzymatic assay of a chromogenic substrate. Some parents of patients with elevated Nagalase activity opted for weekly GcMAF injections provided by Immuno Biotech Ltd., Guernsey UK (www.gcmaf.eu). GcMAF is purified from human serum obtained from the American Red Cross using 25-hydroxyvitamin D3-Sepharose high affinity chromatography. The protein is then further diluted to obtain therapeutically appropriate levels for patients based on their clinical presentations.
Results: Individuals with ASD (32 males and 8 females, n = 40, ages: 1 year 4 months - 21 years 2 months) had initial and post treatment assessment of Nagalase activity. Dosing of GcMAF was recommended based on previously reported response curves adjusted by the treating clinician for age, weight, and Nagalase levels. The average pre-treatment Nagalase activity of the autism group was 1.93 nmol/min/mg of substrate. This was well above the laboratory reported normal range of <0.95 nmol/min/mg. For the ASD group the average level at the time of second testing was 1.03 nmol/min/mg, reflecting an average reduction of 0.90 nmol/min/mg (P < 0.0001). Apart from the likely immunological benefits of lowering the Nagalase activity of these individuals, uncontrolled observations of GcMAF therapy indicated substantial improvements in language, socialization and cognition. No significant side-effects were reported during the course of injections.
Conclusions: In this first report of Nagalase activity in patients with autism, it appears that most individuals have substantially higher levels than the expected healthy ranges. Although Nagalase is a nonspecific marker of immune dysregulation, its observed levels in autism may have both etiological and therapeutic significance. Importantly, this is also the first report of reduction of Nagalase activity in an autism population with GcMAF injections.
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