NCT06889857Active, not recruitingEarly phase 1
Safety and Efficacy of Intravenous Administration of SHED-CM for ALS
Source: ClinicalTrials.gov · Last updated 15 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 18 Jul 2024
- Start date
- 5 Apr 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Hitonowa Medical
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT06889857
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 10
- From 5 Apr 2024 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 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
Other illness
- Patients with a history of non-invasive respiratory support
- Patients with chronic obstructive pulmonary disease (COPD)
- Patients with cognitive impairment
- Patients with serious respiratory, cardiovascular, hepatic, or renal disease
- Patients with malignant tumors
- Patients with uncontrolled infection
Other
- 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 percent FVC of 60 or less
- Pregnant women or patients who may be pregnant
- Patients who are deemed inappropriate to participate in the study by the principal investigator or research coordinator.
Who the study is looking for
- 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.
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hitonowa Medical Coordinator of this site? Confirm its status | Chiyoda City | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.