Testing new nerve cells to treat ALS

Plain-English translation of NCT07118319 on ClinicalTrials.gov ↗ · Source last updated November 2025 · Translation generated June 2026 · How we translate trials

Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.

What is this trial?

This is an early-stage study testing a new treatment called XS228CN, which consists of nerve cell precursors (immature nerve cells) grown in the laboratory from donated stem cells. Researchers will inject these cells directly into the spinal fluid of people with ALS to see if the treatment is safe and whether it might help slow or improve symptoms. This is one of the first studies in humans testing this approach.

ALS causes progressive weakness because motor neurons—the nerve cells that control movement—gradually die. Currently available treatments can only slow the disease in some patients. This study is exploring whether replacing or supporting these damaged nerve cells with healthy ones grown in the lab could offer a new way to help people with ALS.

Do you qualify?

You likely qualify if…

you are between 18 and 75 years old
you have been diagnosed with definite or probable ALS
your lung function (measured by a breathing test) is at least 70% of normal
you are willing to use effective birth control from enrollment through 6 months after the study ends
you understand the study and agree to participate by signing an informed consent form

You likely don't qualify if…

you have other medical conditions that could cause muscle weakness and haven't ruled them out
you are significantly underweight (BMI below 18.5)
you have active infections requiring antibiotics, antivirals, or antifungals in the past 2 weeks
you have untreated or poorly controlled high blood pressure, heart problems, liver disease, kidney disease, or HIV/hepatitis
you are pregnant or breastfeeding, or have had cancer in the past 5 years

What participation looks like

If you enroll, you will receive an injection of the treatment cells directly into your spinal fluid (through a procedure called a lumbar puncture or spinal tap). The study will test two different doses to find the safest and most effective amount. You will have regular follow-up visits to check your health, breathing, muscle strength, and how you are tolerating the treatment. The study involves a small group of 12 people total, and researchers will closely monitor your safety and any changes in your ALS symptoms over time.

AI-generated summary from trial data · Jun 7, 2026 · Not medical advice

Trial locations(1 site)

China

Peking University Third Hospital, Beijing, Beijing Municipality