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:

• You (or your legal guardian) must be willing to give written consent to take part in this study.
• You must be between 18 and 60 years old; any gender may apply.
• You must have been officially diagnosed with ALS (Lou Gehrig's disease) using internationally recognised guidelines, and your diagnosis must have been made between 6 and 24 months before the screening date.
• You must have already tried standard treatments that have not worked well or where your condition has continued to get worse.
• Your lungs must be working at 50% or more of their expected capacity, based on a breathing test.
• During the screening period, your blood oxygen levels must not fall below 90% for more than 2% of any night measured.
• The trial doctor must consider you to be in good nutritional health, and your body weight relative to your height (BMI) must be 18.5 or above.
• If you are a man or a woman who could become pregnant, you must agree to use effective birth control from the time you sign the consent form until one year after treatment begins.
• You must be willing and able to attend appointments and have your medical information collected throughout the study.

Who may not be able to join:

• You have muscle weakness symptoms but it has not been clearly confirmed that you have ALS.
• You have been diagnosed with severe memory or thinking problems, dementia, or a serious mental health condition such as schizophrenia, bipolar disorder, or severe depression.
• You have any other condition that affects how your nerves or muscles work, such as nerve damage in the limbs or a muscle disease caused by metabolism problems.
• You have a history of cancer or have previously been diagnosed with any type of malignant tumour.
• In the two weeks before screening, you had an active infection that needed treatment with antibiotics, antiviral, or antifungal medicines.
• You have ALS and are also experiencing breathing (respiratory) failure.
• You have previously received a transplant of cells from another person, or had an organ transplant.
• You have taken part in another clinical trial within the three months before screening.
• You have had a tracheostomy (a surgical opening in the throat to help breathing) or you currently use a machine to help you breathe.
• You have a documented history of a severe allergic reaction to general anaesthesia medicines, or have had other serious allergic reactions in the past.
• You have a brain condition that causes increased pressure inside your skull.
• Your liver function blood tests during screening show certain abnormal results above specified levels (confirm with trial site).
• Your kidney function blood tests during screening show certain abnormal results, such as raised creatinine levels or reduced kidney filtration rate (confirm with trial site).
• You have other significantly abnormal laboratory test results during screening (confirm with trial site).
• You have hepatitis A, active hepatitis B, active hepatitis C, hepatitis E, HIV, or syphilis.
• You have reduced or impaired consciousness.
• Your blood clotting tests show abnormal results, or you are currently taking blood-thinning (anticoagulant) medication.
• You have high blood pressure that remains poorly controlled (above 160/100 mmHg) even with treatment.
• You have severe diabetes with advanced complications, or another condition affecting how you move your limbs, such as severe arthritis or gout.
• You have had surgery or a significant injury (including a broken bone) within the past month.
• You are pregnant or currently breastfeeding.
• The trial doctor believes you have another poorly controlled health condition or any other reason that makes it unsuitable for you to take part.

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