Treatment of idiopathic facial paralysis (Bell's Palsy) and secondary facial paralysis with extracellular vesicles: a pilot safety study.

BACKGROUND: Paralysis of the facial nerve (CN VII) is one of the most debilitating issues that any patient can encounter. Bell's palsy is the most commonly seen mononeuropathy. Although usually self-limited, symptomatology can persist for decades in persistent cases. The non-surgical alternative therapies discussed in this study are successful without reconstruction and are regenerative.

OBJECTIVE AND DESIGN: We sought to determine a safe new treatment could be developed to restore facial nerve function using extracellular vesicles (EVs) in patients who have been unable to return to normal under a variety of conditions. We performed a pilot safety study of 7 patients with idiopathic and secondary facial paralysis to determine if any functional restoration was possible. Each patient had symptomology for varying periods of time, with diverse House-Brackmann scores. They were all treated with the same protocol of extracellular vesicles (EVs) over a 4-week period of time and were evaluated both before and after treatment.

CASE PRESENTATIONS: All patients in this study received treatment by their private physicians prior to entering the study. A record review was completed, with independent physical examinations. House-Brackmann scores and Facial Disability Indices were obtained prior to, and after completing the study. EVs were injected into the area of the main trunk of the facial nerve on the affected side, and an intravenous drip of EVs on visits during weeks 1, 2, and 4.

CONCLUSIONS: All seven patients enrolled in the study improved with this treatment protocol. After the second week of treatment, we saw a progression of independent motion of the affected eyelid, brow motion, and commissure. Although all patients began at different House-Brackman starting points, almost all ended at the same endpoint on the scale over the same period of time - four weeks. No adverse effects were encountered. Clearly, the duration of the treatment protocol needs to be longer than one month. The pathomechanism is still unknown. But it appears that the mechanism is reversible. At last, these patients can have hope.

TRIAL REGISTRATION: The Institute of Regenerative and Cellular Medicine IRB approval number: IRCM-2021-304.