Stem cells injected into spine: hope for paralysis?
NCT ID NCT06976229
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests a new treatment called XS228, made from special stem cells that can become nerve cells. The goal is to see if injecting these cells into the spine is safe and tolerable for people who had a spinal cord injury 2 to 8 weeks ago. Up to 12 adults with injuries between the neck and lower back will take part. The study focuses on safety first, but will also check if the treatment helps improve movement or nerve function.
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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Jul 2025
- Expected to finish
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May 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 65 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: 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). 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. Exclusion Criteria: * 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. 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.
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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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The Third Affiliated Hospital of Sun Yat-sen University
RECRUITINGGuangzhou, Guangdong, 510630, China
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