Phase 1 Motor Neurone Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 65 years, of any gender
• People whose spinal cord was injured due to a traumatic event or a complication of surgery, affecting the spine between the neck (C4 level) and lower back (L2 level)
• People whose spinal cord injury has been classified as ASIA Impairment Scale Grade A, B, or C (ranging from complete to partial loss of function), confirmed by MRI
• People whose spinal cord injury occurred between 14 and 60 days before the screening visit (considered a subacute stage)
• People who are able to have children (male or female) and agree to use effective non-hormonal contraception during the trial and for 6 months after it ends
• People who are willing and able to follow the study procedures
• People who, or whose legal guardian, can provide written consent to participate

Who may not be able to join:

• People whose spinal cord injury is accompanied by a severe traumatic brain injury that makes it impossible to assess neurological function
• People with a high neck injury (C1–C3 level) that has caused breathing or circulation problems serious enough to require a breathing tube or tracheostomy
• People with life-threatening injuries to multiple other organs at the same time
• People with unstable injuries to organs such as the lungs, liver, kidneys, or spleen, as determined by the study doctor
• People with a previous spinal cord injury or existing spinal conditions such as ankylosing spondylitis, spinal deformities, spinal tumours, spinal vascular malformations, or syringomyelia
• People with an active infection at the lower back area where a lumbar puncture would be performed, or who have raised pressure inside the skull at the time of screening
• People with serious infections such as sepsis, septic shock, or severe pneumonia
• People with neurological or psychiatric conditions that could interfere with study assessments, such as Parkinson's disease, severe dementia, myasthenia gravis, stroke, Guillain-Barré syndrome, or diabetic neuropathy
• People with moderate-to-severe heart failure (NYHA Class III or IV)
• People with severe uncontrolled heart rhythm problems, such as sick sinus syndrome or third-degree heart block
• People who have had unstable chest pain or a heart attack within the 3 months before joining
• People with pulmonary hypertension, pulmonary embolism, or suspected blood clots in the lungs at the time of screening
• People with blood pressure that is too high (systolic above 160 mmHg or diastolic above 100 mmHg) or too low (systolic below 90 mmHg or diastolic below 60 mmHg)
• People with active autoimmune diseases that require immune-suppressing medications, such as uncontrolled overactive thyroid or lupus
• People who are unwilling or unable to take immune-suppressing medications as required by the study protocol
• People with certain abnormal blood test results, including liver enzyme levels, kidney function, blood clotting, platelet count, or haemoglobin below the thresholds set by the trial (confirm with trial site)
• People with a history of severe allergic reactions to the trial drug or its ingredients, which include human albumin or lactated Ringer's solution
• People who test positive for hepatitis B with a high viral load, or who test positive for hepatitis C, HIV, or syphilis
• People who are unwilling to undergo the spinal injection procedure used in this trial
• People who are pregnant or breastfeeding
• People who have had an active cancer or received cancer treatment within the past 5 years
• People who have participated in another drug trial within the 3 months before joining
• People considered unsuitable for any other reason, at the discretion of the study doctor

Important: Always verify eligibility with the trial site directly before applying.