Retrospective Study on the Safety and Therapeutic/Improvement Effects of Intravenous Administration of SHED-CM for ALS (SHED-CAH2023)

Hitonowa Medical

Status: Completed

Conditions: Amyotrophic Lateral Sclerosis

Treatments: Biological: The study drug is SHED-CM manufactured by U-Factor

Study type: Observational

Funder types: Other

Identifiers

NCT06608719

SHED-CM-ALS-H-2023

Details and patient eligibility

About

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

Full description

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.

Enrollment: 24 patients

Sex: All

Ages: 38 to 81 years old

Volunteers: No Healthy Volunteers

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.

Trial design

24 participants in 1 patient group

Receiving the study drug

Description:

Patients diagnosed with ALS who visited our hospital and were administered SHED-CM between January 1, 2022, and November 30, 2023.

Treatment:

Biological: The study drug is SHED-CM manufactured by U-Factor