Inteligex
Give Back FundedGenetically engineered human stem cells to replace damaged cells and regrow tissue after brain and spinal cord injury.
Solution overview
Inteligex develops ReStaRT (Region-Specific Stem Cell and Regenerative Therapeutic) cells — region-specific neural progenitor cells derived from human iPSCs — to replace lost cells, regrow tissue, regenerate neural circuits and restore function after traumatic cervical spinal cord injury. Lineage-biasing and matrix modification tailor the cells for acute cervical SCI, where the upper limbs, respiratory function and autonomic regulation are all at risk.
Scientific progress to date
In a validated rat cervical SCI model, ReStaRT cell transplantation restored forelimb grip strength with statistical significance (p = 0.01). The team has selected clinical-grade GMP iPSC lines and completed the cell-banking process required for regulatory-quality manufacturing. The programme builds on more than $20 million of prior research funding at UHN and the University of Toronto.
Benefit to the Canadian health-care system
Spinal cord injury affects more than 2 million people across G7 countries, with cervical injuries accounting for the majority of new cases. The lifetime economic cost of a cervical SCI is estimated at $3.5M–$4.7M per patient. A regenerative therapy that restores even partial upper-limb and respiratory function would dramatically reduce lifetime care costs and improve quality of life for a population currently without disease-modifying options.
Proposed use of funds
Capital will fund the IND-enabling programme: GLP toxicology studies, biodistribution and persistence studies, scale-up of GMP manufacturing, and regulatory submission preparation to reach a Phase 1 / 2a first-in-human trial. The clinical advisory board — including W. Dalton Dietrich III (The Miami Project) and Armin Curt (Balgrist) — has confirmed that the milestones achievable with this capital are sufficient to support IND filing.
Team
Dr. Fehlings is one of the world's foremost spinal cord injury researchers and neurosurgeons. He holds the Robert Campeau Family Foundation / Dr. C. H. Tator Chair in Brain and Spinal Cord Research at UHN and has published more than 600 peer-reviewed papers. He leads the clinical and scientific direction of the ReStaRT programme.
Scientific Director Emeritus of The Miami Project, Dr. Dietrich brings four decades of SCI research experience and a track record of translating preclinical discoveries into clinical programmes.
Professor and Head of Spinal Cord Injury Medicine at the University of Zurich / Balgrist, Dr. Curt is a global leader in clinical SCI trials and outcome assessment, and chairs the International Spinal Cord Injury Classification committee.