Autism
Protocol
Biologic
Follow-up
Endpoint parameters
Neutrojen Au 100 Supraselective
(peripheral- Intravenous infusion)
Neutrojen Au 100 Proprietary biologic / Bone Marrow derived mononuclear cells (autologous trial)
1Y: 30D, 3M, 6M, 12M Baseline diagnostic tests, Gadolinium MRI Brain & Spine, tests for recognized genetic mutations; UBE3A; neuroligins (NLGN), SH3 and multiple ankyrin repeat domains (SHANK), neurexin (NRXN) families, and contactin associated protein (CNTNAP2), Autism Spectrum Disorder Evaluation Scale, 25 foot walk test (ambulatory subjects), end-point MRI
Neurogenesis and Revascularization, change in lesion volume (if detected in baseline MRI), improvement in social interaction, behavioral, verbal and non-verbal communication, improvement in impaired functions, Language learning ability, reduced repetitive behavior, mental development, muscle tone
Inclusion criteria: Autism spectrum disorder; Autistic Disorder / Asperger Syndrome / Pervasive Developmental Disorder (Ag15-40), no family history of ASD, Fragile X syndrome, tuberous sclerosis, Down syndrome and other chromosomal disorders. Ultrasound negative for CCSVI, Human immunodeficiency virus/Hepatitis B Virus/Hepatitis C Virus, malignancies, bleeding tendencies, pneumonia, renal failure, severe liver dysfunction, severe anemia [Hemoglobin < 8], space occupying lesion in brain, other acute medical conditions such as respiratory infection, pyrexia may disqualify participants, CCSVI rule-out via CTV/MRV, recognized genetic mutations may disqualify patients