Amyotrophic Lateral Sclerosis
Protocol
Biologic
Follow-up
Endpoint parameters
Neutrojen A 150 Supraselective (Venoplasty 2x IJV + Intrathecal)
Neutrojen A 150 Proprietary biologic / Bone Marrow derived mononuclear cells (autologous trial)
1Y: 30D, 3M, 6M, 12M Baseline: diagnostic tests, CCSVI, Gadolinium MRI Brain & Spine, CT cerebral venography, tests for recognized genetic mutations; familial ALS, defective LXRA protein production by NR1H3, 25 foot walk test (ambulatory subjects), UV exposure, vitamin D synthesis, SF12, PCS / MCS, ALSFRS, ALSAQ- 5, CGBS Scale,
end-point MRI
Immunosuppression (Microglia), reduction in buildup of glutamate, reduction in ADP/Lactic acid buildup, neurogenesis, revascularization, improved cognitive functions, UV exposure, vitamin D synthesis log, 25 foot walk, upper extremity functions, change in T2 lesion volume (if detected in baseline MRI)
Inclusion criteria: Sporadic Amyotrophic Lateral Sclerosis (ALS); M/F (Ag18-70); Spinal stenosis (Myelopathy) negative, Pulmonary embolism negative (preferable rule-out via CTA), recognized genetic mutations such as ‘familial’ mutations may disqualify patients (autosomal recessive diagnosis)