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XS228

Also known as XS-228, XS228CN, iPSC-derived motor neuron progenitor cells

Bottom line

Very early: a first safety test of donor-derived nerve cells in about 12 people in China, with no published results. Company claims of slower decline come from uncontrolled cases, and most treatments at this stage do not reach approval.

Very early. This drug is in its first safety trial in people and has not been tested for whether it helps in ALS. Most drugs at this stage never reach approval. More about early drugs

XS228 is a cell therapy: young nerve cells grown in a lab from donor stem cells, meant to replace or support the motor neurons lost in ALS. It is made by XellSmart in Suzhou, China. A 12-person Phase 1 trial at Peking University Third Hospital dosed its first participant in autumn 2025. There are no published results.

Information checked 5 Nov 2026

Evidence: Results pending

Studies: 1 running

Trials are running, but there are no efficacy results yet.

How we decide the overall verdict: How to read this site.

At a glance

CompanyXellSmart Bio-Pharmaceutical (Suzhou)Explanation and sources

XellSmart (士泽生物) is a private Chinese company that makes off-the-shelf cell therapies from induced pluripotent stem cells for nervous system diseases, including Parkinson's disease, spinal cord injury and ALS. XS228 is its ALS product.

Sources

  1. XellSmart Secures FDA Clearance for Three Phase I INDs of Allogeneic iPSC-Derived Cell Therapies Targeting Major CNS DiseasesXellSmart (via PR Newswire) · 2 Jun 2025 · Company press release
  2. XellSmart's Allogeneic iPSC-derived Cell Therapies for Parkinson's Disease and ALS Officially Approved by the U.S. FDA for Phase I Clinical TrialsXellSmart (via PR Newswire) · 15 Apr 2025 · Company press release
How it worksLab-grown young nerve cells meant to support or replace lost onesAllogeneic iPSC-derived motor neuron progenitor cellsExplanation and sources

Induced pluripotent stem cells (iPSCs) are adult cells reprogrammed in a lab so they can become almost any cell type. XellSmart turns donor iPSCs into motor neuron progenitors, early-stage cells that are meant to mature into motor neurons or support existing ones. Because the cells come from donors rather than each patient, they can be made in large batches. Earlier stem cell therapies for ALS have not been shown to work in large controlled trials.

Sources

  1. FDA clears cell therapy XS-228 for ALS Phase 1 clinical trialALS News Today · 24 Apr 2025 · News
  2. Derived Motor Neuron Progenitor Cells (XS228CN) in Subjects With ALS (NCT07118319)ClinicalTrials.gov · Trial registry
StagePhase 1Phase 1 in people with ALS in China, about 12 people · Dosing: people with alsExplanation and sources

China's drug regulator approved registered trials in May 2025, and the first participant in the Beijing trial was dosed by early October 2025. The FDA also cleared a US Phase 1 trial in early 2025, but we found no sign it has started. The company calls the Chinese study Phase I/II; ClinicalTrials.gov lists it as Phase 1. The FDA granted orphan drug status in 2023, which is not a decision on whether it works.

Sources

  1. 士泽生物联合北医三院完成iPSC再生神经细胞治疗渐冻症受试者给药 (First participant dosed in XS228 registered trial)ByDrug (PharmCube) · 2 Oct 2025 · News
  2. Derived Motor Neuron Progenitor Cells (XS228CN) in Subjects With ALS (NCT07118319)ClinicalTrials.gov · Trial registry
  3. XellSmart's Allogeneic iPSC-derived Cell Therapies for Parkinson's Disease and ALS Officially Approved by the U.S. FDA for Phase I Clinical TrialsXellSmart (via PR Newswire) · 15 Apr 2025 · Company press release
  4. XellSmart Secures FDA Clearance for Three Phase I INDs of Allogeneic iPSC-Derived Cell Therapies Targeting Major CNS DiseasesXellSmart (via PR Newswire) · 2 Jun 2025 · Company press release
  5. Orphan designation for allogenic spinal motor neuron precursor cells in ALS (XellSmart)US FDA · 22 Nov 2023 · Regulator
Best reported effectSafety study; no published effect dataSafety; ALSFRS-R exploredExplanation and sources

No results have been published. XellSmart says patients treated in an earlier 2024 Chinese study did well on safety and declined more slowly than expected, but it has not released numbers, and there was no placebo group. Such claims cannot show whether the cells help.

This is the most favourable result reported. See all key studies for the full picture.

Sources

  1. XellSmart's Allogeneic iPSC-derived Cell Therapies for Parkinson's Disease and ALS Officially Approved by the U.S. FDA for Phase I Clinical TrialsXellSmart (via PR Newswire) · 15 Apr 2025 · Company press release
  2. XellSmart Secures FDA Clearance for Three Phase I INDs of Allogeneic iPSC-Derived Cell Therapies Targeting Major CNS DiseasesXellSmart (via PR Newswire) · 2 Jun 2025 · Company press release
Who it's forAdults with probable or definite ALS, breathing at least 70%All ALS · Spinal injection, once or 4 timesExplanation and sources

The trial takes adults aged 18 to 75 with definite or probable ALS and breathing capacity of at least 70% of normal. People with only upper motor neuron symptoms (primary lateral sclerosis) are excluded. Cells are given by lumbar puncture, a needle into the lower back.

Sources

  1. Derived Motor Neuron Progenitor Cells (XS228CN) in Subjects With ALS (NCT07118319)ClinicalTrials.gov · Trial registry
  2. 士泽生物联合北医三院完成iPSC再生神经细胞治疗渐冻症受试者给药 (First participant dosed in XS228 registered trial)ByDrug (PharmCube) · 2 Oct 2025 · News
What's nextSafety results from the 12-person Phase 1 trialExpected January 2027Explanation and sources

XellSmart has not given a date for results. The trial registry estimates the main data will be collected by January 2027, with the study finishing in September 2028.

Sources

  1. Derived Motor Neuron Progenitor Cells (XS228CN) in Subjects With ALS (NCT07118319)ClinicalTrials.gov · Trial registry
Can I join?Recruiting at one site in Beijing, ChinaRecruiting nowExplanation and sources

The registry lists one recruiting site in Beijing. The FDA-cleared US trial has not been registered as recruiting that we could find. We found no expanded access programme.

Sources

  1. Derived Motor Neuron Progenitor Cells (XS228CN) in Subjects With ALS (NCT07118319)ClinicalTrials.gov · Trial registry
  2. XellSmart's Allogeneic iPSC-derived Cell Therapies for Parkinson's Disease and ALS Officially Approved by the U.S. FDA for Phase I Clinical TrialsXellSmart (via PR Newswire) · 15 Apr 2025 · Company press release

Signal: Silent

Signal measures how often, and how reliably, XellSmart Bio-Pharmaceutical (Suzhou) tells the public about this drug. It says nothing about whether the drug works. A quiet company isn't necessarily a bad sign, but regular, on-time updates help patients plan.

Last company update2 Jun 2025 (17 months ago)0 / 40
Company updates in the last 12 months00 / 35
Promises keptNot enough history yet (neutral score)12.5 / 25
Signal score13 / 100 · Silent

70 or more is Active, 45 or more is Steady, 20 or more is Quiet, below 20 is Silent. Full method.

Timeline

6 events, newest first. Company updates are marked; independent news and regulator decisions are shown too.

2025

  1. NewsByDrug (PharmCube)

    First participant dosed in the registered trial

    Chinese industry news reported that the first participant received XS228 cells by lumbar puncture in Beijing with no complications, and had moved on to follow-up.

  2. Trial registryClinicalTrials.gov

    Beijing Phase 1 trial registered

    The 12-person trial at Peking University Third Hospital was posted on ClinicalTrials.gov.

  3. Press releaseFrom the companyXellSmart (via PR Newswire)

    Company update on its cell therapy trials

    XellSmart said a registered Phase I/II trial of XS228 in ALS had been started by Peking University Third Hospital.

  4. NewsALS News Today

    ALS News Today reports the FDA clearance

    ALS News Today reported the FDA clearance and the company's claims from early studies in China, noting these came from the company.

  5. Press releaseFrom the companyXellSmart (via PR Newswire)

    FDA clears a US Phase 1 trial

    XellSmart announced the FDA had cleared Phase 1 trials of XS228 in ALS and of a related cell therapy in Parkinson's disease, and said earlier Chinese patients had done well.

2023

  1. RegulatoryUS FDA

    FDA orphan drug designation

    The FDA listed XellSmart's motor neuron precursor cells as an orphan drug for ALS. This gives business incentives; it is not a judgement on whether the treatment works.

All sources for this page

  1. Orphan designation for allogenic spinal motor neuron precursor cells in ALS (XellSmart)US FDA · 22 Nov 2023 · Regulator
  2. XellSmart's Allogeneic iPSC-derived Cell Therapies for Parkinson's Disease and ALS Officially Approved by the U.S. FDA for Phase I Clinical TrialsXellSmart (via PR Newswire) · 15 Apr 2025 · Company press release
  3. FDA clears cell therapy XS-228 for ALS Phase 1 clinical trialALS News Today · 24 Apr 2025 · News
  4. XellSmart Secures FDA Clearance for Three Phase I INDs of Allogeneic iPSC-Derived Cell Therapies Targeting Major CNS DiseasesXellSmart (via PR Newswire) · 2 Jun 2025 · Company press release
  5. 士泽生物联合北医三院完成iPSC再生神经细胞治疗渐冻症受试者给药 (First participant dosed in XS228 registered trial)ByDrug (PharmCube) · 2 Oct 2025 · News
  6. Derived Motor Neuron Progenitor Cells (XS228CN) in Subjects With ALS (NCT07118319)ClinicalTrials.gov · Trial registry