Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in Japan / NCT06889857
Active, not recruiting Early Phase 1

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

NCT06889857 · tracked via the Priya Life Science Japan tracker
Sponsor
Hitonowa Medical
Phase
Early Phase 1
Started
2024-04-05
Last updated
2025-09-15

Condition(s) studied

Amyotrophic Lateral Sclerosis

Investigational drug(s) / intervention(s)

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

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.

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.

Eligibility

Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: Patients who meet the following inclusion criteria (1) to (6) at the time of Informed consent 1. Patients who have provided written informed consent to participate in the study. 2. Patients who are at least 20 years of age at the time of obtaining informed consent. 3. Patients diagnosed with isolated or familial ALS and diagnosed as definite, the probable, or the probable laboratory-supported by updated Awaji criteria. 4. Patients with severity 1 or 2 on ALS severity criteria. 5. Outpatients. 6. Patients residing in Japan who can communicate in Japanese. Exclusion Criteria: Patients who do not meet any of the exclusion criteria (1) to (15) at the time of Informed consent 1. Patients with a tracheostomy 2. Patients with a history of non-invasive respiratory support 3. Patients with a percent FVC of 60 or less 4. Patients with chronic obstructive pulmonary disease (COPD) 5. Patients newly treated with edaravone or riluzole (oral) within 4 weeks prior to Informed consent 6. Patients receiving HAL medical leg type treatment 7. Patients receiving intravenous edaravone 8. Patients with cognitive impairment 9. Pregnant women or patients who may be pregnant 10. Patients with serious respiratory, cardiovascular, hepatic, or renal disease 11. Patients with malignant tumors 12. Patients with uncontrolled infection 13. Patients who have participated in other clinical trials within 12 weeks prior to obtaining consent 14. Patients with a history of drug allergy or severe allergic disease (e.g., anaphylactic shock) or concomitant history 15. Patients who are deemed inappropriate to participate in the study by the principal investigator or research coordinator.

Primary outcome measure(s)

  • All Adverse Events — Immediately after each administration and up to 4 weeks post-treatment
    This measure will check the total number of adverse events (AEs) reported during the study, categorized by CTCAE Ver 5.0 .
  • Number of Clinically Significant Changes in Laboratory Test Results — Baseline, Week 4, Week 8, Week 12, and at follow-up (Week 16).
    This measure will track the number of events where clinically significant abnormalities are detected in laboratory test parameters, including blood count, biochemistry, and coagulation function tests. Changes from baseline to follow-up are evaluated based on predefined clinical thresholds.
  • Number of Clinically Significant Changes in Vital Signs — Baseline, Week 4, Week 8, Week 12, and at follow-up (Week 16).
    This measure will evaluate the number of events where clinically significant changes in vital signs occur. Parameters include systolic blood pressure, diastolic blood pressure, pulse rate, body temperature, and SpO2. Each event will be assessed at two time points: immediately after treatment and after follow-up session, comparing values to baseline.
  • Safety assessment during the study period: Adverse events - Self- and other findings — Immediately after each administration and up to 4 weeks post-treatment
    Medical examination, subjective findings, Other findings

Trial sites (1)

FacilityCityRegionStatus
Hitonowa Medical Chiyoda City Tokyo

Other trials for the same condition

FUSION: A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ION363 in Amyotrophic Lateral Sclerosis Participants With Fused in Sarcoma Mutations (FUS-ALS) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06889857 on ClinicalTrials.gov ↗ ← All trials in Japan