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

NCT06889857 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-09-15

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • U-Factor Co.,Ltd.

    collaborator UNKNOWN

  • Hitonowa Medical

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-05
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06889857 on ClinicalTrials.gov