Intranasal delivery of AlloEx Exosome®, an exosome-rich mesenchymal stem cell secretome, was evaluated in 18 patients with progressive motor disorders including ALS, Kennedy Disease, Congenital Myasthenic Syndrome (CMS), and Lewy Body Dementia (LBD). A total of 32 treatments were administered using the Tian Tx360® nasal applicator.

Safe, Needle-Free Treatment

Across all patients and treatments, there were no adverse events of any kind. All patients remained stable immediately after treatment, that evening, and the following day.

Meaningful Clinical Improvements

Most patients experienced improvements in strength, motor function, or related symptoms:

• ALS:
  13 of 14 patients showed strength improvement. Mean ALSFRS-R scores increased after each treatment (from 30.93 pre-treatment → 34.00 after the third dose).
  Muscle grade testing showed gains in hands, shoulders, core, hips, knees, and feet.
• Kennedy Disease:
  Improved energy (+45%), better ambulation, major reduction in pain, improved balance, and increased grip strength.
• Congenital Myasthenic Syndrome:
  Dramatic gains in respiratory capacity (MIP 26 → 73 cmH₂O), grip strength, endurance, tremor elimination, improved gait, and increased 6-minute walk distance.
• Lewy Body Dementia:
  Improved balance, motor function, cognition, sleep, speech, and daily movement. Benefits were maintained and increased with repeat treatments.

Conclusion

Intranasal delivery of AlloEx Exosomes® was completely safe and produced improvements in strength and function in most patients with ALS, Kennedy Disease, CMS, and dopamine-resistant Lewy Body Dementia — marking a significant development for conditions with no prior treatment capable of increasing strength.