NCT06889857

Safety and Efficacy of Intravenous Administration of SHED-CM for ALS

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Hitonowa Medical · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the safety and efficacy of Stem Cell from Human Exfoliated Deciduous teeth Conditioned Media (SHED-CM) in patients with Amyotrophic Lateral Sclerosis (ALS), using the Japanese version of the revised ALS Functional Rating Scale (ALSFRS-R) as an indicator.

Detailed description

The main objective of this study is to evaluate the safety and efficacy of Stem Cell from Human Exfoliated Deciduous teeth Conditioned Media in patients with Amyotrophic Lateral Sclerosis (ALS), Particular focus will be placed on improving neurological function, slowing the rate of symptom progression, and improving the patient's quality of life. What are the advantages of this therapy over standard therapy? and for which patients it is most effective ?

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
BIOLOGICAL	The study drug is SHED-CM manufactured by U-Factor	This study will involve informed consent, a 12-week observation period, a 12-week study drug administration period, and a 4-week follow-up period.

Timeline

• Start date: 2024-04-05
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-03-21
• Last updated: 2025-09-15

Locations

1 site across 1 country: Japan