Phase 1 Parkinson's 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 between 50 and 75 years old (male or female)
• People who have been formally diagnosed with Parkinson's disease according to established medical diagnostic guidelines
• People who have been living with their Parkinson's diagnosis for at least 5 years
• People whose Parkinson's symptoms during an "off" period fall within a moderate-to-severe range on a standard symptom rating scale (Hoehn-Yahr score of 3 to 4 during off-time)
• People who experience an average of at least 2.5 hours per day when their Parkinson's medication is not working well ("off time")
• People who have been on a stable Parkinson's medication plan for at least 1 month before the screening visit
• People whose Parkinson's medication once worked well but has since become less effective, or who have developed movement-related side effects from their medication that affect daily life
• People whose symptoms improve by more than 30% on a standard motor assessment when given a levodopa test dose
• People who have completed all vaccinations recommended by local health authorities at least three months before the first treatment dose
• People whose blood test results meet specific minimum levels for white blood cells, a type of infection-fighting white blood cell (neutrophils), platelets, and haemoglobin (confirm exact values with trial site)
• People (or their legal guardian) who are willing to give written informed consent to take part in the study

Who may not be able to join:

• People whose condition is a form of Parkinson's-like syndrome other than standard Parkinson's disease (such as atypical, hereditary, or secondary Parkinson's syndromes)
• People in advanced stages of Parkinson's disease who experience severe, disabling uncontrolled movement problems at peak medication times or unpredictable, widely fluctuating symptoms
• People with serious memory or thinking difficulties, including a low score on a standard cognitive test (MMSE below 24), or who are unable to reliably keep a symptom diary or provide informed consent
• People with a history of serious mental illness, strong suicidal thoughts or behaviour in the past 12 months, or a suicide attempt in the past 5 years, as assessed by a standard rating scale
• People whose brain scans (CT or MRI) show significant brain shrinkage, growths, fluid build-up, abnormal blood vessels, or other structural changes that investigators determine could make surgery riskier
• People who currently have active internal bleeding, had a needle inserted into an artery in a hard-to-compress location within the past week, or had bleeding from the gut or urinary tract within the past 3 weeks
• People who have previously had brain surgery related to Parkinson's disease, including deep brain stimulation (DBS) or procedures targeting specific brain areas
• People with blood clotting problems
• People with abnormal liver or kidney function detected during screening blood tests
• People who have used certain medications, including: benzodiazepine sedatives above recommended doses for more than 4 weeks in the month before enrolment; immune-suppressing drugs (other than those used in this trial); antipsychotic medications within 3 months before treatment; botulinum toxin injections or certain other treatments for muscle stiffness or movement disorders within 6 months before treatment; anti-seizure medications or a history of epilepsy; or cell-based therapies within 3 months before screening
• People for whom general anaesthesia, stereotactic (precision brain) surgery, MRI scans, or PET scans are medically unsuitable (for example, due to sleep apnoea or chronic lung disease)
• People with certain heart or circulation problems, including heart failure, severe or poorly controlled irregular heartbeat, significant ECG abnormalities, unstable chest pain or a heart attack within the past 3 months
• People with poorly controlled diabetes or poorly controlled high blood pressure
• People with an active infection during screening that has not been brought under control with antibiotic, antifungal, or antiviral treatment (minor skin infections are generally not excluded — confirm with trial site)
• People with serious lung disease during the screening period
• People with autoimmune diseases that are not well controlled
• People with severe joint disease, significant limping, severe stroke effects, severe bone thinning (osteoporosis), or a serious injury within the past month, where investigators consider these may affect trial assessments
• People with any history of cancer, except for certain fully cured skin cancers or early-stage cervical or breast conditions as specified (confirm with trial site)
• People with serious infectious diseases
• People who are pregnant, breastfeeding, planning to become pregnant during the study or within 6 months after it ends, or who are unwilling to use effective contraception
• People who have taken part in another clinical trial of a drug or medical device within the 3 months before treatment
• People with a long history of heavy alcohol use or drug misuse
• People with a history of severe allergic reactions, or known allergies to the study drug or immune-suppressing medications used in the trial
• People with severe depression
• People experiencing hallucinations that persist even after their Parkinson's medications have been reviewed and adjusted
• People who have previously undergone MRI-guided focused ultrasound thalamotomy (a type of non-invasive brain procedure)
• People who have used immune-suppressing medications within the 3 months before the trial, except for those used as part of this study
• People whom the investigator considers unsuitable for any other reason

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