Phase 2 Motor Neurone Disease Trial, Recruiting

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

Who might be able to join this trial:

• The person must be willing and able to give written consent before any study procedures begin, and must understand what they are agreeing to.
• The person must have a confirmed or probable ALS diagnosis based on a standard set of diagnostic guidelines called the revised El Escorial criteria.
• The person must be between 18 and 65 years old.
• The person must have lung function (measured by a breathing test called FVC) above 70%.
• Symptoms must have started no more than 24 months before joining the trial.
• The person must score at least 26 on a standard ALS function rating scale (ALSFRS-R), with minimum scores on each individual section of the scale (confirm with trial site for exact score requirements).
• The person's ALS must be progressing at a measurable pace — people whose disease is progressing very slowly (less than 0.3 points per month on the rating scale) will not be included, and the trial will confirm faster progression over a 12-week observation period before the person is formally enrolled.
• The person must either be on a stable dose of the ALS medication riluzole for more than 30 days before screening, or not be taking riluzole at all and not plan to start it during the study.
• The person must be medically suitable to undergo a temporary course of immune-suppressing medication.
• The person must have a caregiver who is willing and able to attend all follow-up visits throughout the study, even if the person's mobility decreases over time.

Who may not be able to join:

• People who have a psychiatric condition or any neurological disease other than ALS.
• People who have any other illness or treatment that could make participation unsafe, or any condition that the neurosurgeon believes could complicate surgery.
• People who have had cancer at any point in the past 10 years.
• People who have received immune-suppressing treatment within the 12 weeks before screening, or who have an active autoimmune disease or active infection, including hepatitis B, hepatitis C, or HIV.
• People who have cognitive impairment (problems with thinking, memory, or understanding).
• People who cannot have an MRI scan, a spinal fluid sample (CSF withdrawal), or a skin biopsy due to any medical reason.
• People who are unable to understand the informed consent form.
• People who are pregnant or breastfeeding.
• People who have previously received any stem cell or somatic cell therapy.
• People who have taken part in another clinical treatment trial or received experimental medications outside of a trial within one month before this study begins.

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