Multiple sclerosis


Multiple Sclerosis

The intervention relates to methods and compositions for treating a patient having or at risk of developing a vascular-related degenerative neurological disease such as multiple sclerosis, by superselectively administering stem cells and growth factors to the patient.

Endpoint parameters

Neutrojen M 150 – Supraselective (Venoplasty 2x IJV + Intrathecal)
Neutrojen M 150 Proprietary biologic / Bone Marrow derived mononuclear cells (autologous trial)
1Y: 30D, 3M, 6M, 12M Baseline: diagnostic tests, CCSVI, MSFC: 25 foot walk test (ambulatory subjects), 9-hole peg test, PASAT, Gadolinium MRI Brain & Spine, CT cerebral venography, genetic mutations; defective LXRA protein production by NR1H3, UV exposure, vitamin D synthesis, EDSS, MSIS- 29, Beck’s depression scale,
end-point MRI
Anti-inflammation, immune- modulation; immunosuppression
(T-lymphocyte), reduced restenosis (due to vascular endothelial repair), remyelination (oligodendrocyte regeneration); reduced relapses, UV exposure, vitamin D synthesis log, MSFC change; change in cognitive functions, walking gate and speed, upper extremity functions, change in T2 lesion volume (to quantify neurogenesis)
Inclusion criteria: Relapsing Remitting (RR) / Primary Progressive (PP) Multiple Sclerosis; M/F (Ag18-70); lesions demonstrated on brain MRI; EDSS 1.0~8.5, Spinal stenosis (Myelopathy) negative, Pulmonary embolism negative (preferable rule-out via CTA), recognized genetic mutations may disqualify patients



The Neutrojen M 150 – Supraselective allogeneic treatment involves selective administration of stem cells close to the sites of damage in multiple minimally invasive procedures. The allogeneic treatment (higher efficacy) is currently available at Somata Genesis’s Trinidad facility while the autologous bone marrow variant also utilizing the same Supraselective protocol for stem cell administration is available at our USA and India sites. All treatments adhere to regulatory standards for inclusion, procedures and follow-up as per US FDA 21CFR guidelines governing clinical research and bioanalysis.

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