Phase 2 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 50 to 75 years old, of any gender
• People who are able to understand the purpose of the trial and sign a consent form
• People who have been diagnosed with Parkinson's Disease according to a specific set of internationally recognised diagnostic guidelines (the MDS 2015 criteria)
• People whose Parkinson's Disease diagnosis was made between 4 and 20 years ago
• People who are medically suitable for brain surgery under general anaesthetic, and able to undergo MRI and PET scans
• People whose Parkinson's Disease symptoms, during "off" periods (when medication is less effective), fall within a certain severity range on a standard staging scale called Hoehn-Yahr (stages 2.5 to 4)
• People whose Parkinson's motor symptoms score above 35 on a standard assessment scale during an "off" period, and who respond positively to a specific medication test involving levodopa
• People whose blood and other laboratory test results fall within acceptable ranges during the screening period and before any transplant procedure

Who may not be able to join:

• People who have a form of parkinsonism that is not standard Parkinson's Disease (sometimes called "atypical parkinsonism")
• People who have previously had certain brain surgeries, including deep brain stimulation, pallidotomy, or other procedures affecting relevant brain areas
• People whose past brain scans (CT or MRI) showed conditions such as brain injury, abnormal blood vessels, fluid on the brain, or brain tumours, or who have brain imaging abnormalities that would significantly increase the risk of surgery
• People with a history of serious heart or stroke-related conditions
• People with a history of cancer (malignant tumours)
• People who have previously received any cell-based therapy
• People who have had significant bleeding problems or a clotting disorder in the 3 months before screening, or who are unable to stop blood-thinning or anti-clotting medications for at least 5 days before surgery
• People who have used steroid medications (glucocorticoids) or immune-suppressing drugs heavily and over a long period in the 3 months before signing the consent form
• People with a history of mental illness considered by the trial doctor to affect participation, or who have had thoughts of suicide or a suicide attempt in the past year or currently
• People who have used botulinum toxin (such as Botox) within 6 months before signing the consent form
• People who have active epilepsy or are currently taking anti-epilepsy medication
• People with a history of dementia or severe memory or thinking difficulties, or whose cognitive score on a specific screening assessment is above a certain threshold, or who are unable to keep an accurate diary or sign the consent form due to cognitive impairment
• People with severe depression or severe anxiety at the time of screening
• People with certain abnormal test results at screening, including: abnormal blood clotting results; abnormal immune system test results assessed by the trial doctor as unsuitable for participation; poorly controlled high blood pressure; severe drops in blood pressure when standing; or poorly controlled blood sugar levels in people with diabetes
• People who have conditions that make brain surgery medically unsafe, or who have had other surgeries within 6 months before screening that the trial doctor believes would affect participation
• People with other serious ongoing illnesses affecting major body systems, such as serious lung or heart conditions, moderate to severe asthma, or severe chronic obstructive pulmonary disease (COPD)
• People who test positive for HIV, syphilis, hepatitis C, or active hepatitis B (with elevated viral levels), or who have active tuberculosis, or other active infections the trial doctor considers may affect participation or results
• People with alcohol dependency or who test positive for illegal drug use
• People with a known allergy or sensitivity to any medications used during the study, including a group of drugs called macrolides (confirm with trial site)
• Women who could become pregnant and are not surgically sterilised, not post-menopausal, or unwilling to use effective contraception for 2 years after receiving the study treatment; and women who are currently breastfeeding; and men who are not surgically sterilised or unwilling to use effective contraception for 2 years after receiving the study treatment
• People who have received electroconvulsive therapy (electric shock therapy) within 30 days before surgery
• People who are currently in another clinical trial, or who received an experimental treatment in another clinical study within 3 months before surgery
• People whom the trial doctor considers unlikely to reliably follow the trial requirements
• People currently being treated with apomorphine, or with levodopa/carbidopa delivered by infusion (pump therapy)
• People who experience severe uncontrolled movement problems (dyskinesia) both when their medication is working and when it is not

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