Stem cells injected into ALS patients in first human trial
NCT ID NCT07118319
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tests whether injecting lab-grown nerve cells (made from stem cells) into the spinal cord is safe for people with ALS, a fatal disease that destroys movement control. Twelve participants will receive the cells either once or four times over six months. The main goal is to check for side effects, not yet to prove it works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- iPSC-derived motor neuron progenitor cells (XS228CN)
- What this could lead to
- If safe and effective, this could point toward a cell-replacement therapy to slow or halt ALS progression.
- What could go wrong
- This is a very early Phase 1 trial with only 12 participants, focused on safety. It may not show any benefit, and cell therapies carry risks like immune rejection or tumor formation.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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: 1. 18-75 years of age (inclusive of 18 and 75 years), regardless of gender; 2. Diagnosed of definite or probable ALS according to the revised EI Escorial criteria; 3. Respiratory function FVC at baseline was ≥70% of the predicted value (FVC%); 4. Patients with birth-potential (both male and female) must agree to use effective non-drug contraceptive measures from the time of signing the informed consent until 6 months after the conclusion of the trial; 5. Volunteer to participate in the clinical study, understand and sign the informed consent form. Exclusion Criteria: 1. Subject has signs and symptoms of neuromuscular weakness, and other causes of muscle weakness cannot be ruled out; 2. Baseline body mass index (BMI) \< 18.5 kg/m²; 3. Primary lateral sclerosis presenting only with upper motor neuron symptoms; 4. Significant psychiatric disorders that the investigator assesses may affect evaluation; 5. Diseases causing neurological or muscular dysfunction, such as metabolic muscle diseases or myasthenia gravis; 6. Diagnosed autoimmune diseases with uncontrolled severe arthritis or other conditions (e.g., lameness) that the investigator assesses may affect evaluation; 7. Acute active infections requiring antibiotics, antivirals, or antifungals that occurred within the 2 weeks prior to screening and are not controlled; 8. Subject diagnosed with active pulmonary tuberculosis or treated for suspected tuberculosis; 9. Diagnosed severe pulmonary diseases that the investigator assesses may affect evaluation; 10. Poorly controlled hypertension; 11. Previous or detected cardiac abnormalities; 12. A history of cirrhosis, chronic hepatitis, or liver function at screening; 13. A history of chronic kidney disease; 14. Previous history of bleeding, abnormal clotting, or being treated with anticoagulation; 15. Active hepatitis B, active hepatitis C, human immunodeficiency virus (HIV) antibody or treponema pallidum antibody positive at screening; 16. History of severe trauma or surgery and may affect the assessment judged by investigator; 17. Subjects with contraindications to lumbar puncture, including menifestations of injection site infection or high intracranial pressure. 18. Those who have had a malignant tumor within 5 years prior to screening or are undergoing antitumor therapy; 19. Have participated in other clinical trials within 3 months prior to screening; 20. Pregnant or breastfeeding women; 21. Subject who is judged by the investigator to be unsuitable for the clinical trial.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking University Third Hospital
RECRUITINGBeijing, Beijing Municipality, 100191, China
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