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 who were first diagnosed with early-onset Parkinson's disease (EOPD) between the ages of 18 and 50, based on recognised 2015 diagnostic guidelines for Parkinson's disease
• People who are between 18 and 70 years old at the time of enrolling in the trial, of any gender
• People who have lived with Parkinson's disease for at least 5 years
• People whose movement and balance difficulties fall within a specific range of severity, both when their medication is working and when it is not — measured using a standard Parkinson's rating scale (confirm with trial site for which phase applies)
• People whose movement symptoms score above a certain level on a standard assessment when their medication is not active (confirm with trial site)
• People who show a positive response to a levodopa (L-dopa) test, meaning their symptoms improve noticeably after taking the medication
• People whose movement fluctuations (times when medication works less well) cannot be adequately controlled even with recommended medication doses
• People who have been on a stable dose of Parkinson's medication for at least 4 weeks before joining the trial
• People who are medically suitable for brain surgery under general anaesthetic, and able to undergo CT or MRI brain scans
• People who agree to delay any other planned (non-urgent) brain surgery until at least 24 months after joining the trial
• People who agree not to participate in any other clinical studies for 24 months after receiving the trial treatment
• People (or their legal representatives) who understand the study procedures, agree to take part voluntarily, and sign a consent form

Who may not be able to join:

• People whose Parkinson's symptoms are caused by something other than primary Parkinson's disease, or who have a related but different condition sometimes called a "Parkinson's plus" syndrome
• People in advanced stages of Parkinson's disease who experience severe, disabling uncontrolled movements (dyskinesia) or widely unpredictable symptoms
• People who have previously had certain types of brain surgery, including deep brain stimulation (DBS), stereotactic brain surgery, or other procedures affecting the brain; or who have medical reasons that make surgery unsafe
• People currently receiving levodopa through intestinal infusion, apomorphine injections, or continuous daily drug infusions for Parkinson's
• People who received certain treatments for muscle stiffness or involuntary movements (such as botulinum toxin or baclofen injections) within 6 months before joining
• People who have used steroid medications or immune-suppressing drugs for an extended period within 3 months before screening
• People who have previously received cell therapy of any kind
• People who received electroconvulsive therapy (ECT) within 30 days before the trial treatment
• People who received or plan to receive certain vaccines (including COVID-19, flu, shingles, or pneumococcal vaccines) within 3 months before screening or during the trial
• People with a history of mental illness that researchers consider unsuitable for participation; or people with serious or recent suicidal thoughts or any history of suicide attempts in the past 2 years
• People with active epilepsy or who are currently taking anti-epileptic medication
• People with a history of dementia or severe memory and thinking difficulties, or who show significant cognitive impairment at screening
• People experiencing severe anxiety at the time of screening
• People whose previous brain scans show injuries or abnormalities (such as brain trauma, tumours, hydrocephalus, or vascular malformations) that would significantly increase surgical risk
• People with uncontrolled autoimmune disease
• People with a history of serious heart or stroke-related conditions
• People with other serious ongoing medical conditions affecting major body systems
• People with severe arthritis, significant limping, severe stroke after-effects, severe osteoporosis, or a serious injury (such as a hip or leg fracture) within the past month that could affect how the study is measured
• People with a current or past diagnosis of cancer (malignant tumour)
• People with active serious blood clotting disorders or significant bleeding risk within 3 months before signing the consent form; or people unable to safely stop blood-thinning medications at least 10 days before surgery
• People with a known history of abnormal blood clotting
• People with abnormal laboratory (blood or urine) test results during screening (confirm specific values with trial site)
• People with known allergies to any medications used in the study
• People who are pregnant, breastfeeding, or planning to become pregnant during the study
• People of childbearing potential who are unwilling or unable to use effective contraception from the time of signing consent until at least 24 months after treatment; or who are unwilling to agree not to donate eggs or sperm during that period (confirm specific contraception requirements with trial site, as the source criteria wording in this section appears to contain an ambiguity)
• People currently participating in another clinical trial, or who received an investigational treatment in another study within 1 month before joining
• People researchers consider unlikely to follow the study requirements
• People with any other situation that researchers believe could affect their safety or the reliability of study results

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