Spinal Cord InjuryPhase 1NCT06976229
Safety and Early Efficacy of iPSC-Derived Motor Neuron Progenitor Cells (XS228) in Subacute Spinal Cord Injury: A Phase I Trial
A Phase 1 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
This Phase I clinical trial is designed to evaluate the safety, tolerability of XS228 ( iPSC-Derived Motor Neuron Progenitor Cells) in patients with Subacute Spinal Cord Injury Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injury, Safety, Clinical Trials
- 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?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 2 Jul 2025to 30 May 2028
- Phase
- Phase 1
- 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, 1 recruiting
- Recruiting
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Limin Rong, prof and M.D, 02085253333, ronglm@mail.sysu.edu.cn
About this study
Official title: A Phase I Clinical Study Evaluating the Safety, Tolerability, and 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
This Phase I clinical trial is designed to evaluate the safety, tolerability of XS228 ( iPSC-Derived Motor Neuron Progenitor Cells) in patients with Subacute Spinal Cord Injury
- Conditions
- Spinal Cord Injury, Safety, Clinical Trials, Efficacy, Induced Pluripotent Stem Cells, Human Motor Neuron Progenitor
- Being tested
- Allogeneic Human Induced Pluripotent Stem Cell (iPSC)-Derived Motor Neuron Progenitor Cells
- Keywords
- spinal cord injury, safety, efficacy, clinical trials, Induced Pluripotent Stem Cells, Human motor neuron progenitor, Transplantation
- 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
Also called XS228 Cell Injection, XS228
Description:
The Single Ascending Dose (SAD) and Muliple Ascending Dose (MAD) stages were built up in the study. XS228 in SAD and MAD following intrathecal injection through lumbar puncture in subacute spinal cord Injury participants.For SAD,the participants will single intrathecal injection with the dose level as 5×10^7 cells 、1.5×10^8 cells. For MAD, the participants will intrathecal injection of XS228 in Day 1, Day15, Day 29, Day 43 under the dose level of 5×10^7 cells、1.5×10^8 cells.Dose escalation followed a rule-based 3+3 design.
XS228 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 subacute spinal cord injury and represents a novel approach in regenerative medicine.
| Study group | Role | What they receive |
|---|---|---|
| XS228 for injection | Experimental | The Single Ascending Dose (SAD) and Muliple Ascending Dose (MAD) stages were built up in the study. XS228 in SAD and MAD following intrathecal injection through lumbar puncture in Subacute Spinal Cord Injury participants. Receives: Biological: Allogeneic Human Induced Pluripotent Stem Cell (iPSC)-Derived Motor Neuron Progenitor Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of adverse events (AEs) and serious adverse events (SAEs)
To evaluate the safety and tolerability of XS228 in A single dose and the last dose of MAD treatment of Subacute Spinal Cord Injury through Adverse events (AE) related to XS228 ,incidence of SAE（serious adverse events).The severity of AEs observed during the trial will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Measured: 28 days after administration in the SAD treatment and 28 days after the final (fourth) administration in the MAD treatment
DLT（Dose-limiting toxicity）
To evaluate the safety and tolerability of XS228 in A single dose and the last dose of MAD treatment of Subacute Spinal Cord Injury through DLT（Dose-limiting toxicity）.A DLT is defined as any Grade 3 or higher adverse event (based on NCI-CTCAE Version 5.0) that occurs within 28 days following single-dose administration in the SAD treatment or the final dose in the MAD treatment ， which is assessed as related to XS228, or any other significant adverse event as determined by the Safety Review Committee (SRC) .
Measured: 28 days after administration in the SAD treatment and 28 days after the final (fourth) administration in the MAD treatment
RP2D（Recommended Phase 2 Dose）
After the last participant in the MAD treatment of the Phase I trial completes the 28-day DLT observation period following their final dose, the Safety Review Committee (SRC) and the sponsor will jointly determine the recommended dose for Phase II based on safety and preliminary efficacy data from Phase I.
Measured: After the last participant in the MAD treatment of the Phase I trial completes the 28-day DLT observation period
Secondary outcomes (4)
Improvement in ASIA Impairment Scale (AIS) grade
To evaluate the Improvement in ASIA Impairment Scale (AIS) grade after the administration 0f XS228(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.
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.
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 start2 Jul 2025
- Primary completion21 Feb 2028 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT06976229
- Sponsor's protocol ID
- XS228-Allo-SCI-CN1-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.
Publications
Pang M, Kang J, Yang Y, He T, Yao S, Hu B, Li X, Liu B, Rong L. Safety and early efficacy of iPSC-derived motor neuron progenitor cells in subacute spinal cord injury: protocol for a phase I, multicentre, open-label, single-arm trial. BMJ Open. 2026 Jul 8;16(7):e111718. doi: 10.1136/bmjopen-2025-111718.
PubMed 42419896
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 I Clinical Study Evaluating the Safety, Tolerability, and 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
- NCT06976229
- Acronym / sponsor ID
- XS228-Allo-SCI-CN1-P01
- Conditions
- Spinal Cord Injury, Safety, Clinical Trials, Efficacy, Induced Pluripotent Stem Cells, Human Motor Neuron Progenitor
- Keywords
- spinal cord injury, safety, efficacy, clinical trials, Induced Pluripotent Stem Cells, Human motor neuron progenitor, Transplantation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Third Affiliated Hospital, Sun Yat-Sen University
- Study start
- 2 Jul 2025 (actual)
- Primary completion
- 21 Feb 2028 (estimated)
- Study completion
- 30 May 2028 (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.
This Phase I clinical trial is designed to evaluate the safety, tolerability of XS228 ( iPSC-Derived Motor Neuron Progenitor Cells) in patients with Subacute Spinal Cord Injury
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XS228 for injection | Experimental | Biological: Allogeneic Human Induced Pluripotent Stem Cell (iPSC)-Derived Motor Neuron Progenitor CellsThe Single Ascending Dose (SAD) and Muliple Ascending Dose (MAD) stages were built up in the study. XS228 in SAD and MAD following intrathecal injection through lumbar puncture in Subacute Spinal Cord Injury participants. |
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 CellsAlso: XS228 Cell Injection, XS228Description: The Single Ascending Dose (SAD) and Muliple Ascending Dose (MAD) stages were built up in the study. XS228 in SAD and MAD following intrathecal injection through lumbar puncture in subacute spinal cord Injury participants.For SAD,the participants will single intrathecal injection with the dose level as 5×10^7 cells 、1.5×10^8 cells. For MAD, the participants will intrathecal injection of XS228 in Day 1, Day15, Day 29, Day 43 under the dose level of 5×10^7 cells、1.5×10^8 cells.Dose escalation followed a rule-based 3+3 design. XS228 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 subacute spinal cord injury and represents a novel approach in regenerative medicine. | Biological | XS228 for injection |
Primary outcome
The incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: 28 days after administration in the SAD treatment and 28 days after the final (fourth) administration in the MAD treatment
To evaluate the safety and tolerability of XS228 in A single dose and the last dose of MAD treatment of Subacute Spinal Cord Injury through Adverse events (AE) related to XS228 ,incidence of SAE（serious adverse events).The severity of AEs observed during the trial will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
DLT（Dose-limiting toxicity）
Time frame: 28 days after administration in the SAD treatment and 28 days after the final (fourth) administration in the MAD treatment
To evaluate the safety and tolerability of XS228 in A single dose and the last dose of MAD treatment of Subacute Spinal Cord Injury through DLT（Dose-limiting toxicity）.A DLT is defined as any Grade 3 or higher adverse event (based on NCI-CTCAE Version 5.0) that occurs within 28 days following single-dose administration in the SAD treatment or the final dose in the MAD treatment ， which is assessed as related to XS228, or any other significant adverse event as determined by the Safety Review Committee (SRC) .
RP2D（Recommended Phase 2 Dose）
Time frame: After the last participant in the MAD treatment of the Phase I trial completes the 28-day DLT observation period
After the last participant in the MAD treatment of the Phase I trial completes the 28-day DLT observation period following their final dose, the Safety Review Committee (SRC) and the sponsor will jointly determine the recommended dose for Phase II based on safety and preliminary efficacy data from Phase I.
4 secondary outcomes
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.
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.
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.
- Derived from this study: PubMed 42419896Pang M, Kang J, Yang Y, He T, Yao S, Hu B, Li X, Liu B, Rong L. Safety and early efficacy of iPSC-derived motor neuron progenitor cells in subacute spinal cord injury: protocol for a phase I, multicentre, open-label, single-arm trial. BMJ Open. 2026 Jul 8;16(7):e111718. doi: 10.1136/bmjopen-2025-111718.
- 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 1 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: looking for participants now, 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The incidence of adverse events (AEs) and serious adverse events (SAEs) (time frame: 28 days after administration in the SAD treatment and 28 days after the final (fourth) administration in the MAD treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06976229, which also lists 1 linked publication.
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.