Spinal Cord InjuryPhase 2NCT06974968
Efficacy of iPSC-Derived Motor Neuron Cells (XS228) in Subacute Spinal Cord Injury: A Phase II Randomized Controlled Trial
A Phase 2 study testing Allogeneic Human Induced Pluripotent Stem Cell (iPSC)-Derived Motor Neuron Progenitor Cells in people with Spinal Cord Injury and Safety, run by XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd. at 1 site in China.
Trial summary
Purpose: This clinical trial is studying an investigational cell therapy called XS228-a lab-made stem cell product designed to help repair damaged nerves in the spinal cord. The goal is to see if XS228 is safe and can improve movement, sensation, and function in people with recent spinal cord injuries. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injury, Safety, Efficacy
- What is being tested?
- Allogeneic Human Induced Pluripotent Stem Cell (iPSC)-Derived Motor Neuron Progenitor Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2028to 26 May 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 to 65 years (inclusive), regardless of gender.
- Etiology: Cervical (C4) to lumbar (L2) spinal cord injury (SCI) caused by traumatic injury or surgery-related factors.
- Severity:
- Classified as ASIA Impairment Scale (AIS) Grades A, B, or C. MRI-confirmed evidence of spinal cord injury.
- Disease Stage:
- Primary SCI occurring 14 to 60 days prior to screening (subacute phase).
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- Contraception:
- Participants of childbearing potential (male and female) must agree to use effective non-hormonal contraceptive methods during the trial and for 6 months after trial completion.
- Compliance:
- Voluntarily participate in the clinical study. Ability to understand and comply with study procedures. Participant or legal guardian can provide written informed consent.
Who cannot join
- Neurological Inability
- Primary spinal cord injury (SCI) during screening with concomitant severe traumatic brain injury precluding neurological function assessment.
- Respiratory/Circulatory Instability
- High cervical SCI (C1-C3) causing respiratory/circulatory compromise requiring endotracheal intubation or tracheostomy.
- Life-Threatening Multiorgan Dysfunction
- Concurrent severe injuries to other organ systems with life-threatening dysfunction.
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- Unstable Thoracoabdominal Injuries
- Injuries to lungs, liver, kidneys, spleen, etc., deemed unstable by the investigator.
- Prior Spinal Pathology
- History of SCI or coexisting spinal disorders (e.g., ankylosing spondylitis, spinal deformities, primary/metastatic spinal tumors, spinal vascular malformations, syringomyelia).
- Local Infection/Increased ICP
- Active infection at the lumbar puncture site or intracranial hypertension during screening.
- Severe Infections
- Sepsis, septic shock, or severe pneumonia (per IDSA/ATS 2007 diagnostic criteria).
- Confounding Neurological/Psychiatric Conditions
- Parkinson's disease, severe dementia, myasthenia gravis, stroke, Guillain-Barré syndrome, diabetic neuropathy, or other conditions interfering with study assessments.
- Cardiac Abnormalities (any of the following):
- Congestive heart failure (NYHA Class III/IV). Severe uncontrolled arrhythmias (e.g., sick sinus syndrome, third-degree AV block).
- Unstable angina or acute myocardial infarction within 3 months prior. Pulmonary Complications
- Pulmonary hypertension, pulmonary embolism, or suspected embolism during screening.
- Uncontrolled Hypertension/Hypotension
- Systolic BP >160 mmHg or diastolic BP >100 mmHg; or systolic BP <90 mmHg or diastolic BP <60 mmHg.
- Active Autoimmune Diseases
- Requiring immunosuppressants (e.g., uncontrolled hyperthyroidism, systemic lupus erythematosus).
- Immunosuppressant Non-Compliance
- Unwillingness or inability to use immunosuppressants per protocol.
- Laboratory Abnormalities (any of the following):
- ALT/AST >2×ULN or total bilirubin >2×ULN. eGFR <60 mL/min/1.73m² (CKD-EPI 2021 formula). APTT/PT >2.5×ULN (without anticoagulants). Platelets <100×10⁹/L or hemoglobin <90 g/L. Allergy
- History of severe allergies or hypersensitivity to trial drug/excipients (human albumin, lactated Ringer's solution).
- Infectious Diseases
- HBsAg+ with HBV DNA >1000 IU/mL; HCV-Ab+; HIV-Ab+; or TP-Ab+. Lumbar Puncture Refusal
- Unwillingness to undergo intrathecal administration procedures. Pregnancy/Lactation
- Females who are pregnant or breastfeeding. Malignancy
- Active malignancy or anticancer therapy within 5 years prior. Recent Clinical Trial Participation
- Enrollment in another drug trial within 3 months prior. Investigator Discretion
- Any condition deemed unsuitable for participation by the investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Limin Rong, 02085253333, ronglm@mail.sysu.edu.cn
Limin Rong, prof and M.D
About this study
Official title: A Phase II Clinical Study Evaluating the Preliminary Efficacy of Human Allogeneic Induced Pluripotent Stem Cell (iPSC)-Derived Motor Neuron Progenitor Cells (XS228 Cell Injection) in Patients With Subacute Spinal Cord Injury
Purpose: This clinical trial is studying an investigational cell therapy called XS228-a lab-made stem cell product designed to help repair damaged nerves in the spinal cord. The goal is to see if XS228 is safe and can improve movement, sensation, and function in people with recent spinal cord injuries.
Study Treatment: XS228 contains specialized nerve-supporting cells derived from human stem cells. These cells are injected into the spinal fluid (intrathecal administration) in a single dose.
Read more
Who Can Join? Adults aged 18-65 with a spinal cord injury (thoracic or lumbar level) that occurred 2-12 weeks before enrollment. Participants must have severe but incomplete paralysis (ASIA Impairment Scale Grade A , B or C).
Study Plan:
Phase II (Main Study): About 60 participants will be randomly assigned to receive either XS228 or a placebo (inactive solution) in a 2:1 ratio.
Follow-up: Patients will be monitored for 1 year, with regular check-ups to assess safety, nerve function, and recovery progress.
What Researchers Are Looking For:
Primary Goal: Measure changes in leg and arm function using the ASIA Motor Score at 6 months.
Secondary Goals:
Improvement in ASIA Impairment Scale (AIS) grade (e.g., from "complete" to "incomplete" paralysis).
Recovery of sensation and bladder/bowel control. Safety (monitoring for side effects like infections or immune reactions). Exploratory Tests: MRI scans and biomarker tests in spinal fluid to see if the treatment helps nerve regrowth.
Why This Study Matters: If successful, XS228 could become the first stem cell therapy to promote meaningful recovery in spinal cord injury patients. Currently, no treatments exist to repair nerve damage-this trial aims to change that.
Read the detailed description
Title: A Randomized, Double-Blind, Placebo-Controlled Phase II Trial to Evaluate the Efficacy and Safety of XS228 Cell Injection in Patients with Subacute Thoracic or Lumbar SCI
Study Type: Interventional (Clinical Trial) Phase: Phase II Allocation: Randomized (2:1, XS228 vs. Placebo) Masking: Double-blind (Participant, Investigator) Primary Purpose: Treatment
Hypothesis:
XS228 (allogeneic iPSC-derived motor neuron progenitor cells) will demonstrate statistically significant improvement in motor function (ASIA Motor Score) compared to placebo at 6 months post-treatment.
The therapy will exhibit an acceptable safety profile with no dose-limiting toxicities (DLTs).
Intervention Details
Investigational Product:
XS228 Cell Injection: Cryopreserved suspension of optimal dose from Phase I. Placebo: Normal saline with identical packaging/labeling. Administration: 4 intrathecal injection via lumbar puncture (Day 1, Day 15, Day 29 and Day 43).
Concomitant Therapies:
Standard rehabilitation protocols (uniform across sites). Prohibited: Other experimental therapies or stem cell treatments during the study.
- Conditions
- Spinal Cord Injury, Safety, Efficacy, Clinical Trial, Induced Pluripotent Stem Cells, Human Motor Neuron Progenitor
- Being tested
- Allogeneic Human Induced Pluripotent Stem Cell (iPSC)-Derived Motor Neuron Progenitor Cells, Placebo
- Keywords
- Spinal Cord Injury, Safety, efficacy, clinical trial, Induced Pluripotent Stem Cells, Human motor neuron progenitor, Transplantation, RCT
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic Human Induced Pluripotent Stem Cell (iPSC)-Derived Motor Neuron Progenitor CellsBiological
Description:
XS228 Cell Injection is an investigational, allogeneic cell therapy product composed of motor neuron progenitor cells (MNPCs) derived from human induced pluripotent stem cells (iPSCs). This advanced therapy medicinal product (ATMP) is being developed for the treatment of spinal cord injury (SCI) and represents a novel approach in regenerative medicine.
PlaceboOther
Also called Standard rehabilitation protocols
Standard rehabilitation protocols
| Study group | Role | What they receive |
|---|---|---|
| XS228 Interventional Group | Active comparator | Investigational Product:
XS228 Cell Injection: Cryopreserved suspension of optimal dose from Phase I. Placebo: Normal saline with identical packaging/labeling. Administration: 4 intrathecal injection via lumbar puncture (Day 1, Day 15, Day 29, Day 43). Receives: Biological: Allogeneic Human Induced Pluripotent Stem Cell (iPSC)-Derived Motor Neuron Progenitor Cells |
| Placebo Control Group | Placebo comparator | Standard rehabilitation protocols Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in ASIA Impairment Scale (AIS) grade
Measured: Improvement in ASIA Impairment Scale (AIS) grade from baseline at Day 29, Day 90, Day 180, Day 270, and Day 360 after the first dose administration.
Secondary outcomes (4)
Changes in American Spinal Injury Association (ASIA) Motor Score
Changes in motor scores assessed by the ASIA score scale (total score range from 0 to 100, higher values represent a better outcome)
Measured: From baseline at Day 29, Day 90, Day 180, Day 270, and Day 360 after the first dose administration.
Changes in American Spinal Injury Association (ASIA) Sensory Score
Changes in sensory scores assessed by the ASIA score scale (total score range from 0 to 224, higher values represent a better outcome)
Measured: From baseline at Day 29, Day 90, Day 180, Day 270, and Day 360 after the first dose administration.
Changes in Spinal Cord Independence Measure-III (SCIM-III)
SCIM-III(range: 0-100, with lower score indicating greater disability)
Measured: From baseline at Day 29, Day 90, Day 180, Day 270, and Day 360 after the first dose administration.
Safety and Tolerability
Description: Systematic evaluation of:
Adverse events (AEs) up to 360 days post-infusion Immunogenicity (anti-HLA antibodies, T-cell responses)
Assessment Methods:
CTCAE v5.0 grading Neurological monitoring (ISNCSCI exams) CSF analysis for inflammation markers
Measured: From baseline at Day 29, Day 90, Day 180, Day 270, and Day 360 after the first dose administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start25 May 2028 (estimated)
- Primary completion25 May 2031 (estimated)
- Study completion26 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Third Affiliated Hospital, Sun Yat-Sen University
- Responsible party
- Sponsor
- Investigators
- Limin Rong, prof and M.D, Principal investigator, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974968
- Sponsor's protocol ID
- XS228-Allo-SCI-CN2-P01
- Status last verified
- Aug 2025
- First submitted
- 8 May 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this stage, the sponsor has not yet finalized a decision regarding the sharing of individual participant data (IPD). The potential risks and benefits of data sharing, including patient privacy, regulatory requirements, and intellectual property considerations, are still under evaluation. A final determination will be made following further internal review and alignment with applicable data protection laws, institutional policies, and ethical guidelines. If IPD sharing is approved in the future, details regarding data accessibility, anonymization methods, and request procedures will be specified in an updated plan.
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study Evaluating the Preliminary Efficacy of Human Allogeneic Induced Pluripotent Stem Cell (iPSC)-Derived Motor Neuron Progenitor Cells (XS228 Cell Injection) in Patients With Subacute Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT06974968
- Acronym / sponsor ID
- XS228-Allo-SCI-CN2-P01
- Conditions
- Spinal Cord Injury, Safety, Efficacy, Clinical Trial, Induced Pluripotent Stem Cells, Human Motor Neuron Progenitor
- Keywords
- Spinal Cord Injury, Safety, efficacy, clinical trial, Induced Pluripotent Stem Cells, Human motor neuron progenitor, Transplantation, RCT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Third Affiliated Hospital, Sun Yat-Sen University
- Study start
- 25 May 2028 (estimated)
- Primary completion
- 25 May 2031 (estimated)
- Study completion
- 26 May 2031 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: This clinical trial is studying an investigational cell therapy called XS228-a lab-made stem cell product designed to help repair damaged nerves in the spinal cord. The goal is to see if XS228 is safe and can improve movement, sensation, and function in people with recent spinal cord injuries.
Study Treatment: XS228 contains specialized nerve-supporting cells derived from human stem cells. These cells are injected into the spinal fluid (intrathecal administration) in a single dose.
Who Can Join? Adults aged 18-65 with a spinal cord injury (thoracic or lumbar level) that occurred 2-12 weeks before enrollment. Participants must have severe but incomplete paralysis (ASIA Impairment Scale Grade A , B or C).
Study Plan:
Phase II (Main Study): About 60 participants will be randomly assigned to receive either XS228 or a placebo (inactive solution) in a 2:1 ratio.
Follow-up: Patients will be monitored for 1 year, with regular check-ups to assess safety, nerve function, and recovery progress.
What Researchers Are Looking For:
Primary Goal: Measure changes in leg and arm function using the ASIA Motor Score at 6 months.
Secondary Goals:
Improvement in ASIA Impairment Scale (AIS) grade (e.g., from "complete" to "incomplete" paralysis).
Recovery of sensation and bladder/bowel control. Safety (monitoring for side effects like infections or immune reactions). Exploratory Tests: MRI scans and biomarker tests in spinal fluid to see if the treatment helps nerve regrowth.
Why This Study Matters: If successful, XS228 could become the first stem cell therapy to promote meaningful recovery in spinal cord injury patients. Currently, no treatments exist to repair nerve damage-this trial aims to change that.
Detailed description
Title: A Randomized, Double-Blind, Placebo-Controlled Phase II Trial to Evaluate the Efficacy and Safety of XS228 Cell Injection in Patients with Subacute Thoracic or Lumbar SCI
Study Type: Interventional (Clinical Trial) Phase: Phase II Allocation: Randomized (2:1, XS228 vs. Placebo) Masking: Double-blind (Participant, Investigator) Primary Purpose: Treatment
Hypothesis:
XS228 (allogeneic iPSC-derived motor neuron progenitor cells) will demonstrate statistically significant improvement in motor function (ASIA Motor Score) compared to placebo at 6 months post-treatment.
The therapy will exhibit an acceptable safety profile with no dose-limiting toxicities (DLTs).
Intervention Details
Investigational Product:
XS228 Cell Injection: Cryopreserved suspension of optimal dose from Phase I. Placebo: Normal saline with identical packaging/labeling. Administration: 4 intrathecal injection via lumbar puncture (Day 1, Day 15, Day 29 and Day 43).
Concomitant Therapies:
Standard rehabilitation protocols (uniform across sites). Prohibited: Other experimental therapies or stem cell treatments during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XS228 Interventional Group | Active comparator | Biological: Allogeneic Human Induced Pluripotent Stem Cell (iPSC)-Derived Motor Neuron Progenitor CellsInvestigational Product: XS228 Cell Injection: Cryopreserved suspension of optimal dose from Phase I. Placebo: Normal saline with identical packaging/labeling. Administration: 4 intrathecal injection via lumbar puncture (Day 1, Day 15, Day 29, Day 43). |
| Placebo Control Group | Placebo comparator | Other: PlaceboStandard rehabilitation protocols |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age: 18 to 65 years (inclusive), regardless of gender.
- Etiology: Cervical (C4) to lumbar (L2) spinal cord injury (SCI) caused by traumatic injury or surgery-related factors.
- Classified as ASIA Impairment Scale (AIS) Grades A, B, or C. MRI-confirmed evidence of spinal cord injury.
- Primary SCI occurring 14 to 60 days prior to screening (subacute phase).
- Participants of childbearing potential (male and female) must agree to use effective non-hormonal contraceptive methods during the trial and for 6 months after trial completion.
Key exclusion criteria (36 listed)
- Neurological Inability
- Primary spinal cord injury (SCI) during screening with concomitant severe traumatic brain injury precluding neurological function assessment.
- Respiratory/Circulatory Instability
- High cervical SCI (C1-C3) causing respiratory/circulatory compromise requiring endotracheal intubation or tracheostomy.
- Life-Threatening Multiorgan Dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogeneic Human Induced Pluripotent Stem Cell (iPSC)-Derived Motor Neuron Progenitor CellsDescription: XS228 Cell Injection is an investigational, allogeneic cell therapy product composed of motor neuron progenitor cells (MNPCs) derived from human induced pluripotent stem cells (iPSCs). This advanced therapy medicinal product (ATMP) is being developed for the treatment of spinal cord injury (SCI) and represents a novel approach in regenerative medicine. | Biological | XS228 Interventional Group |
| PlaceboAlso: Standard rehabilitation protocolsStandard rehabilitation protocols | Other | Placebo Control Group |
Primary outcome
Improvement in ASIA Impairment Scale (AIS) grade
Time frame: Improvement in ASIA Impairment Scale (AIS) grade from baseline at Day 29, Day 90, Day 180, Day 270, and Day 360 after the first dose administration.
4 secondary outcomes
Changes in American Spinal Injury Association (ASIA) Motor Score
Time frame: From baseline at Day 29, Day 90, Day 180, Day 270, and Day 360 after the first dose administration.
Changes in American Spinal Injury Association (ASIA) Sensory Score
Time frame: From baseline at Day 29, Day 90, Day 180, Day 270, and Day 360 after the first dose administration.
Changes in Spinal Cord Independence Measure-III (SCIM-III)
Time frame: From baseline at Day 29, Day 90, Day 180, Day 270, and Day 360 after the first dose administration.
Safety and Tolerability
Time frame: From baseline at Day 29, Day 90, Day 180, Day 270, and Day 360 after the first dose administration.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: Undecided. At this stage, the sponsor has not yet finalized a decision regarding the sharing of individual participant data (IPD). The potential risks and benefits of data sharing, including patient privacy, regulatory requirements, and intellectual property considerations, are still under evaluation. A final determination will be made following further internal review and alignment with applicable data protection laws, institutional policies, and ethical guidelines. If IPD sharing is approved in the future, details regarding data accessibility, anonymization methods, and request procedures will be specified in an updated plan.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Limin Rong, prof and M.D principal investigator
Third Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Allogeneic Human Induced Pluripotent Stem Cell (iPSC)-Derived Motor Neuron Progenitor Cells in people with Spinal Cord Injury and Safety, run by XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael LEE (+86 21 64027719, CEO@xellsmart.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in ASIA Impairment Scale (AIS) grade (time frame: Improvement in ASIA Impairment Scale (AIS) grade from baseline at Day 29, Day 90, Day 180, Day 270, and Day 360 after the first dose administration.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.