Phase 3 Multiple Sclerosis 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 55 years old at the time of the screening visit
• People who have been diagnosed with multiple sclerosis (MS) according to the 2017 McDonald Criteria
• People whose MS disability level (measured by a standard scale called the EDSS) is 6.0 or below at the time of joining the trial
• People who have specific abnormalities visible on a brain MRI scan that meet certain criteria for MS diagnosis, with MRI reports or images available for review
• People whose MS has been highly active and resistant to treatment, meaning at least 2 episodes of MS disease activity (either a clinical relapse or new MRI changes) in the 3 years before screening, where: at least one episode happened while taking an approved MS medication for at least 1 month; at least one episode happened within the past 12 months; and at least one episode was a confirmed clinical relapse documented by a neurologist
• People whose MS disease activity episodes (as described above) have been confirmed either through a neurologist's records or approved by a study review committee
• People for whom a doctor determines that at least one of the following MS medications would be suitable: cladribine, natalizumab, alemtuzumab, ocrelizumab, ofatumumab, ublituximab, or rituximab — and who have not had a disease activity episode while on that medication, have no medical reason to avoid it, and have not taken it in the past 12 months
• People who have completed a COVID-19 vaccination course at least 14 days before joining the trial, in line with CDC recommendations
• People who either test positive for chickenpox (VZV) antibodies, or have received at least one dose of the Shingrix shingles vaccine at least 4 weeks before joining the trial
• People whose insurance has approved MS treatment with at least one of the qualifying medications listed above
• People who, in the investigator's opinion, are able to follow the study procedures and give informed consent
• People who are willing and able to use contraception as required by the study (applies to women who could become pregnant and men whose partners could become pregnant)
• People who use medicinal or recreational marijuana and are willing to switch to an approved alternative (MARINOL®) if assigned to the stem cell transplant treatment arm

Who may not be able to join:

• People diagnosed with primary progressive MS
• People with a history of neuromyelitis optica spectrum disorder or MOG antibody disease
• People who have taken an experimental treatment within the past 3 months (or longer, depending on the medication), not including FDA-authorised COVID-19 treatments
• People who have had an MS relapse begin, or who have received high-dose intravenous steroid treatment, within one month before joining the trial
• People who start any of the qualifying high-efficacy MS medications between the screening visit and the start of the trial
• People whose brain MRI or spinal fluid test suggests a serious brain infection called progressive multifocal leukoencephalopathy (PML)
• People with a history of low blood cell counts linked to a bone marrow disorder called myelodysplastic syndrome (MDS)
• People with unexplained abnormal blood counts (too few or too many red blood cells, platelets, or white blood cells)
• People with sickle cell anaemia or other inherited red blood cell disorders
• People with evidence of past or current hepatitis B or hepatitis C infection (including previously treated cases); a positive hepatitis B antibody from vaccination alone does not count as evidence of infection
• People with a history of mild to severe liver scarring (cirrhosis)
• People with liver disease where certain liver function blood test results are significantly above the normal range (confirm specific thresholds with trial site)
• People who test positive for COVID-19 on a PCR or similar test within 14 days before joining the trial
• People with evidence of HIV infection
• People who test positive for tuberculosis (TB) on standard screening tests
• People with an active viral, bacterial, parasitic, or opportunistic infection
• People with an active invasive fungal infection
• People who have been hospitalised for an infection or received intravenous or injected antibiotics, antivirals, antifungals, or antiparasitic treatments within 30 days before joining the trial, unless an infectious disease specialist has given clearance
• People who have received a live or live-attenuated vaccine within 6 weeks before joining the trial
• People with significant heart conditions, including certain irregular heart rhythms requiring medication, coronary artery disease with angina or heart failure symptoms, or moderate-to-severe heart valve disease (confirm specific details with trial site)
• People whose heart pumping function (left ventricular ejection fraction) is below 50%
• People with reduced kidney function below a certain threshold on standard testing (confirm with trial site)
• People with reduced lung function on breathing tests, specifically FEV1 below 70% predicted or carbon monoxide diffusion capacity below 70% predicted
• People with poorly controlled diabetes, defined as a blood sugar control measure (HbA1c) above 8%
• People with a history of cancer, with the exception of certain treated skin cancers or cervical pre-cancer; other cured cancers may be reviewed individually by the study committee
• People with a moderate to severe autoimmune rheumatic disease requiring treatment, such as lupus, rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, or related conditions
• People with active peptic ulcer disease confirmed by imaging or endoscopy
• People who have previously had a stem cell transplant (AHSCT)
• People who have previously had a solid organ transplant (such as a kidney or liver transplant)
• People who are pregnant or breastfeeding, or who test positive on a pregnancy test
• People who are not willing or able to accept that infertility may be a permanent side effect of the treatment
• People with a psychiatric illness, intellectual disability, or cognitive difficulties severe enough to affect their ability to consent or follow the study
• People with a known allergy to rabbit or E. coli-derived proteins
• People who have metal implants or electronic devices in their body, or any other condition that prevents them from safely having an MRI scan with contrast dye
• People with a history of stroke, mini-stroke (TIA), or other blood vessel-related brain conditions
• People with other neurological conditions such as brain or spinal cord tumours, inherited progressive brain disorders, CNS sarcoidosis, or other conditions affecting the nervous system
• People with any other serious medical condition that the investigator believes would significantly increase the risk of harm from the treatment
• People with any other medical condition that the investigator considers incompatible with taking part in the trial

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