Status:
ACTIVE_NOT_RECRUITING
Safety and Efficacy of Intravenous Administration of SHED-CM for ALS
Lead Sponsor:
Hitonowa Medical
Collaborating Sponsors:
U-Factor Co.,Ltd.
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
20+ years
Phase:
EARLY_PHASE1
Brief 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 ver...
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), Parti...
Eligibility Criteria
Inclusion
- Patients who meet the following inclusion criteria (1) to (6) at the time of Informed consent
- Patients who have provided written informed consent to participate in the study.
- Patients who are at least 20 years of age at the time of obtaining informed consent.
- Patients diagnosed with isolated or familial ALS and diagnosed as definite, the probable, or the probable laboratory-supported by updated Awaji criteria.
- Patients with severity 1 or 2 on ALS severity criteria.
- Outpatients.
- Patients residing in Japan who can communicate in Japanese.
Exclusion
- Patients who do not meet any of the exclusion criteria (1) to (15) at the time of Informed consent
- Patients with a tracheostomy
- Patients with a history of non-invasive respiratory support
- Patients with a percent FVC of 60 or less
- Patients with chronic obstructive pulmonary disease (COPD)
- Patients newly treated with edaravone or riluzole (oral) within 4 weeks prior to Informed consent
- Patients receiving HAL medical leg type treatment
- Patients receiving intravenous edaravone
- Patients with cognitive impairment
- Pregnant women or patients who may be pregnant
- Patients with serious respiratory, cardiovascular, hepatic, or renal disease
- Patients with malignant tumors
- Patients with uncontrolled infection
- Patients who have participated in other clinical trials within 12 weeks prior to obtaining consent
- Patients with a history of drug allergy or severe allergic disease (e.g., anaphylactic shock) or concomitant history
- Patients who are deemed inappropriate to participate in the study by the principal investigator or research coordinator.
Key Trial Info
Start Date :
April 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06889857
Start Date
April 5 2024
End Date
December 31 2026
Last Update
September 15 2025
Active Locations (1)
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1
Hitonowa Medical
Chiyoda City, Tokyo, Japan, 102-0085