In this study, we will retrospectively evaluate the safety and efficacy of administering SHED-CM for the treatment of ALS.

Amyotrophic Lateral Sclerosis (ALS) is a progressive and irreversible neurodegenerative disease with limited treatment options. Advances in regenerative medicine have opened new avenues for therapeutic interventions. This retrospective cohort study evaluated the safety and efficacy of stem cells from human exfoliated deciduous teeth-conditioned media (SHED-CM) in 24 patients with ALS treated at a single facility between January 1, 2022, and November 30, 2023. Safety assessments included adverse events, vital signs, and laboratory test changes before and after administration, whereas efficacy was measured using the ALS Functional Rating Scale-Revised (ALSFRS-R), grip strength, and forced vital capacity. while ALSFRS-R scores typically decline over time, the progression rate in this cohort was slower, suggesting a potential delay in disease progression. Alternatively, improvements in muscle strength and mobility were observed in some patients. Although adverse events were reported in only 3% of cases (no serious allergic reactions), the treatment-induced changes in vital signs and laboratory results were not clinically significant. The SHED-CM treatment appears to be a safe and potentially effective therapeutic option for patients with ALS. Further research is needed to optimize the SHED-CM treatment; however, this study lays the groundwork for future exploration of regenerative therapies for ALS.

Inclusion Criteria:

• patients who visited our clinic between January 1, 2022 and November 30, 2023 and have been diagnosed with ALS
• male and female patients aged between 16 and 90 years old
• ALSFRS-R score of 12 or more at the time of initial visit

Exclusion Criteria:

• Patients who have a tracheostomy at the time of visit.
• Patients who have expressed their refusal to participate in this study.

Amyotrophic Lateral Sclerosis

This was a retrospective cohort study including patients diagnosed with ALS who visited our hospital between January 1, 2022, and November 30, 2023. We enrolled pa-tients with ALS who received SHED-CM within this period, had a score of 12 or higher on the ALS Functional Rating Scale-Revised (ALSFRS-R), and did not undergo trache-ostomy. All administered data were evaluated for safety. Several patients experienced difficulties presenting to the hospital due to the progression of their ALS; therefore, we evaluated the efficacy of the drug from the first to the 12th dose, which were adminis-tered consecutively, and for which all patients presented to the hospital.

The original data presented in the study are openly available without restrictions.

The original data presented in the study are openly available in FigShare at 10.6084/m9.figshare.26201615.