Study of Intranasal Adult Umbilical Cord Stem Cell Exosome Treatment for Stroke Safety and Effectiveness

What this Trial Is About

Researchers are evaluating the safety and effectiveness of intranasal instillation of cultured allogeneic adult umbilical cord derived mesenchymal stem cell exosomes as a treatment for stroke. This Phase 1 trial explores a novel approach aiming to improve outcomes for stroke patients. The study is sponsored by The Foundation for Orthopaedics and Regenerative Medicine and focuses on monitoring safety over an extended period. Participants will receive two doses of AlloEx, a biological treatment containing approximately 800 billion exosomes, administered as 4 CCs intranasally into both nasal cavities on two consecutive days. For patients with more severe stroke, an additional treatment involving autologous effector cells derived from the patients own blood cells may be used. This procedure involves collecting cells through apheresis and activating lymphocytes. Participants will be evaluated before treatment and at multiple time points after treatment, including 1, 6, 12, 24, 36, and 48 months. Safety will be assessed by monitoring adverse events throughout a four-year follow-up. Researchers will also evaluate the treatments effectiveness during these visits. The total study duration allows for long-term observation of outcomes and potential side effects.

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Exosome Intranasal Instillations for Stroke