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 who have been diagnosed with Parkinson's disease (either a confirmed or probable diagnosis) based on recognised medical diagnostic guidelines from 2015.
• People whose Parkinson's symptoms have not been adequately controlled by medication.
• People who are between 40 and 75 years old at the time of signing the consent form.
• People who have had Parkinson's disease for at least 5 years.
• People who experience both "ON" periods (when medication is working) and "OFF" periods (when medication is not working as well), as shown through movement assessments and a symptom diary.
• People whose involuntary movements (dyskinesia) caused by Parkinson's medication are not severely debilitating (scored below 3 on a standard medical scale).
• People whose movement ability during "OFF" periods and "ON" periods falls within specific ranges on a standard Parkinson's staging scale (confirm with trial site for exact details).
• People whose Parkinson's symptoms improve by 30% or more when assessed with levodopa (a common Parkinson's medication), compared to without medication.
• People whose blood test results at the screening visit show healthy enough levels of white blood cells, platelets, liver enzymes, bilirubin, and kidney function.
• People who are willing to avoid pregnancy during the trial by using abstinence, highly effective contraception, surgical sterilisation, or who are post-menopausal.
• People who are willing to attend and complete all required assessments as set out in the trial protocol.
• People who are able to provide written consent to take part; if signing is not physically possible, verbal consent with a signature from a legally authorised representative may be accepted.

Who may not be able to join:

• People whose brain MRI scan shows abnormalities that suggest a brain condition other than Parkinson's disease.
• People who have a form of parkinsonism that is not standard Parkinson's disease (such as atypical, secondary, or inherited forms).
• People who have a diagnosed or clinically identified problem with immune system function.
• People who have been diagnosed with a major memory or thinking disorder such as dementia, or who are considered at high risk of developing one.
• People who have a tendency to bleed easily or have abnormal blood clotting, based on blood test results.
• People who test positive for certain markers of Hepatitis B virus infection.
• People who test positive for HIV antibodies.
• People who test positive for HTLV-1 antibodies (a type of viral infection).
• People who have an active infection such as Hepatitis C or syphilis.
• People who have a known allergy or medical reason to avoid tacrolimus (an immunosuppressant medication), levodopa, carbidopa, MRI contrast dye, or related medications used in the trial.
• People for whom general anaesthesia is not considered safe, as assessed by relevant medical specialists.
• People who have a serious allergy to gentamicin (an antibiotic) or to products derived from cattle or pigs, which are used in preparing the trial treatment.
• People who currently have any of the following conditions: cancer, epilepsy, uncontrolled psychiatric conditions (such as severe anxiety or depression, bipolar disorder, or schizophrenia), poorly controlled diabetes, or other serious conditions such as stroke-related disorders, heart disease, chronic breathing problems, or inadequately controlled high blood pressure (as determined by the trial doctor).
• People who have a history of: cancer diagnosed within the last 5 years (unless in full remission with an expected survival of more than 5 years), epilepsy, brain bleeding or stroke, uncontrolled psychiatric conditions, a heart condition called congenital long QT syndrome, or prior brain surgeries for Parkinson's such as pallidotomy, thalamotomy, or deep brain stimulation.
• People who are currently pregnant or breastfeeding, or who are unwilling to avoid pregnancy throughout the trial.
• People who have previously received a transplant of a specific type of cell therapy (human iPSC-derived dopaminergic progenitors) for Parkinson's disease.
• People whom the trial doctor considers unsuitable for safe participation, for any reason.

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