Phase 2 Transverse Myelitis 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 who are able to understand what the study involves and are willing to sign a consent form agreeing to participate and to allow their health information to be used.
• People who live close enough to the trial centre, or have a reliable way to travel there.
• People who have a caregiver who is willing and able to help with travel and care during the study.
• People who are between 18 and 70 years old on the day of their screening visit.
• People diagnosed with idiopathic transverse myelitis (TM — a spinal cord condition with no known cause) within the past 120 months (10 years), based on recognised diagnostic guidelines.
• People whose spinal cord MRI scan shows a single area of abnormality at or below a certain level of the neck/upper spine (confirm with trial site).
• People who have tested negative for a specific antibody called NMO IgG (anti-AQP4) on two separate occasions at least 6 months apart.
• People whose brain MRI does not show signs of multiple sclerosis or similar conditions affecting the brain.
• People who are more than 12 months past the point when their TM first started.
• People whose TM has been classified as ASIA A, B, or C, meaning they are either unable to walk at all or unable to walk 100 feet without significant support on both sides.
• People whose neurological symptoms from TM have been stable for at least 3 months.
• People who are medically well enough to go through the study procedures and able to attend all scheduled visits.
• Women who could become pregnant must have a negative pregnancy test during the screening period and before any procedure.
• All participants must agree to use effective contraception throughout the study and for up to one year after it ends.
• People who are up to date with their COVID-19 vaccination.
• People who are up to date with their chickenpox (varicella zoster) vaccination.
• People who are up to date with their current season's flu vaccination.

Who may not be able to join:

• People whose weakness, sensory loss, or other symptoms may be caused by something other than TM that has not been ruled out.
• People with significant cognitive impairment, dementia, or serious mental health conditions such as psychosis, bipolar disorder, or major depression that could interfere with participation.
• People diagnosed with a neurodegenerative disease such as ALS, Parkinson's disease, or Alzheimer's disease.
• People with medical conditions that affect nerve or muscle function, such as significant nerve damage, metabolic muscle disease, or severe joint disease like osteoarthritis.
• People with a serious or unstable medical history involving the heart, lungs, kidneys, liver, hormone systems, blood, active cancer, or active infection, if this would make surgery too risky or make completing the trial unlikely.
• People who have had previous spine surgery or who have an unusual spinal anatomy that would make the treatment delivery procedure impossible, as assessed by a neurosurgeon.
• People with severe narrowing of the spinal canal or significant spinal cord compression.
• People whose spinal cord imaging suggests an abnormal blood vessel condition (such as an arteriovenous malformation) or evidence of a vascular cause for their spinal cord condition.
• People with any signs of cancer or significant abnormal findings in the brain or spinal cord on imaging scans.
• People with uncontrolled high blood pressure (systolic above 180 mmHg and/or diastolic above 110 mmHg).
• People with poorly controlled medical conditions that, in the opinion of the trial doctor or surgeon, would make surgery too risky.
• People who are unable to have an MRI scan for any reason, including having a pacemaker, an implanted defibrillator, certain other electronic or metal implants, or possible metal fragments in the body.
• People with significantly abnormal blood test results at the screening visit, as assessed by the trial investigator.
• People whose immune system is weakened — either due to a medical condition or medication — or who have a condition such as tuberculosis or another ongoing infection that would make immune-suppressing medication unsafe.
• People with significantly elevated liver enzyme levels (AST or ALT more than 3 times the normal upper limit) at screening.
• People with diabetes or a blood sugar marker (HbA1c) above 6.5.
• People with a history of alcohol or drug misuse or dependence within the past year before screening.
• People considered unlikely to follow the study requirements, as judged by the investigator.
• People who have taken part in another experimental treatment study within the past 60 days before screening (and possibly longer for certain biological treatments, assessed case by case).
• People who have pre-existing high levels of certain antibodies (anti-HLA class I or II) that are directed against the study treatment cells (Q-Cells®), as determined by a specific blood test.
• People with a known allergy to the study treatment (Q-Cells®) or any of its components — including chicken eggs — or to any of the immune-suppressing medications used in the study.
• People who have a medical condition or are taking medications that would make it unsafe to use the immunosuppressant drugs tacrolimus, mycophenolate mofetil, or prednisone.
• People who have previously had a stem cell transplant, including T-cell or bone marrow transplants, at any time.
• People with a history of blood clots or deep vein thrombosis (DVT) that has not been properly treated.
• People with a recent (within 1 year) or recurring history of gastrointestinal bleeding or stomach ulcers, or who are actively being treated to prevent these.
• People with reduced kidney function below a certain threshold at screening (confirm with trial site).
• People with a rare inherited enzyme deficiency condition such as Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome.
• People who have received a live virus vaccine within 6 weeks of screening.
• People with a history or evidence of optic neuritis (inflammation of the optic nerve affecting vision).
• People considered inappropriate for the trial for any other reason, at the investigator's discretion.

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