Baby teeth stem cells tested as possible ALS treatment
NCT ID NCT06889857
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-phase trial tests a substance made from stem cells from baby teeth (SHED-CM) in 10 people with ALS. The goal is to see if it is safe and if it might slow the disease. Participants receive the treatment intravenously over 12 weeks, with follow-up for 4 more weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SHED-CM (stem cell from human exfoliated deciduous teeth conditioned media)
- What this could lead to
- If it works, this could point toward a way to slow ALS progression and improve quality of life.
- What could go wrong
- This is a very early, small trial with only 10 participants, so results may not apply to everyone. The treatment may not work or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Apr 2024
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
20 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Hitonowa Medical
Chiyoda City, Tokyo, 102-0085, Japan
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