Neuro-Cells (nepla-tem-cel) / Neuroplast - LARVOL DELTA

Therapeutic Effects of Neuro-Cells on Amyloid Pathology, BDNF Levels, and Insulin Signalling in APPswe/PSd1E9 Mice. (PubMed, Cells) - "Specifically, NC increased expression of Bdnf, Irs2, and Pgc-1α, while attenuating aberrant upregulation of Insr, Igf1r, and markers of ageing and AD-related pathology (Sirt1, Gdf15, Arc, Egr1, Cldn5). These findings indicate that NC therapy mitigates behavioural and molecular hallmarks of AD, potentially via restoration of BDNF and insulin receptor-mediated signalling."

Journal • Preclinical • Alzheimer's Disease • CNS Disorders • Mood Disorders • Psychiatry • CD34 • CLDN5 • EGR1 • GDF15 • IR • IRS2 • SIRT1

Neuro-Cells Mitigate Amyloid Plaque Formation and Behavioral Deficits in the APPswe/PS1dE9 Model of Alzheimer Disease While Also Reducing IL-6 Production in Human Monocytes. (PubMed, Cells) - "Thus, NC treatment alleviated behavioral deficits and reduced amyloid plaque formation in APPswe/PS1dE9 mice, likely via anti-inflammatory mechanisms. The reduction in IL-6 production in human monocytes further supports the potential of NC therapy for the treatment of AD."

Journal • Alzheimer's Disease • CNS Disorders • Inflammation • Psychiatry • GFAP • IL1B • IL6 • PTPRC • STAT3 • TUBB3

Improved Efficacy of Delayed Treatment with Human Bone Marrow-Derived Stromal Cells Evaluated in Rats with Spinal Cord Injury. (PubMed, Int J Mol Sci) - "Human bmSCs were prepared by negative selection without expansion in vitro (NeuroCellsTM)...The histological analysis revealed a lower degree of axonal degeneration and better survival of neurons and oligodendrocytes in bmSCs treated rats. Our results support delayed intrathecal application of bmSCs prepared by negative selection without expansion in vitro as a treatment of SCI."

Journal • Preclinical • Stroma • CNS Disorders • Inflammation • Orthopedics • Solid Tumor

SCI2: Stem Cells in Spinal Cord Injury (clinicaltrials.gov) - P2/3 | N=16 | Active, not recruiting | Sponsor: Neuroplast | Recruiting ➔ Active, not recruiting | N=70 ➔ 16 | Trial primary completion date: Jun 2023 ➔ Feb 2024

Enrollment change • Enrollment closed • Trial primary completion date • CNS Disorders • Musculoskeletal Diseases • Orthopedics

SSCiSCI: Safety Stem Cells in Spinal Cord Injury (clinicaltrials.gov) - P1 | N=10 | Completed | Sponsor: Neuroplast | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Musculoskeletal Diseases • Orthopedics

SCI2: Stem Cells in Spinal Cord Injury (clinicaltrials.gov) - P2/3 | N=70 | Recruiting | Sponsor: Neuroplast | Trial completion date: Apr 2023 ➔ Jun 2024 | Trial primary completion date: Oct 2022 ➔ Jun 2023

Trial completion date • Trial primary completion date • CNS Disorders • Musculoskeletal Diseases • Orthopedics

Neuroplast receives second orphan medicinal product designation for Neuro-Cells, paving the way for application to both chronic and trauma-induced neurodegenerative diseases (PRNewswire) - “The European Union has granted stem cell biotech Neuroplast an orphan medicinal product designation for the applicability of its stem cell technology platform to frontotemporal dementia (FTD), following a positive opinion from The European Medicines Agency (EMA). With the existing orphan disease designation (ODD) for traumatic spinal cord injury (TSCI), Neuro-Cells® is now approved for a fast-track development pathway with market exclusivity for both a trauma-induced and a chronic degenerative central nervous system disorder….This designation for frontotemporal dementia illustrates the broader applicability of the same technology for acute as well as chronic neurodegenerative disorders, paving the way to explore further applicability to conditions such as ALS, Alzheimer's disease, traumatic brain injury, subarachnoid stroke and Parkinson's Disease.”

European regulatory • Orphan drug • Amyotrophic Lateral Sclerosis • CNS Disorders • Dementia • Frontotemporal Lobar Degeneration