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Baby teeth stem cells tested as possible ALS treatment

NCT ID NCT06889857

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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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