Tests a cell therapy injected into the brain for Parkinson's disease
Tests dopamine-making cells, injected into the brain, in adults with Parkinson's disease.
Plain-language title generated from the registry record
Registry title: Stereotactic Intracerebral Injection of IPSC-DAPs in Patients with Parkinson's Disease
Key facts
- Where
- Hangzhou, ChinaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 39 and 75 years old?
Source: NCT06821529, who can take part
Where in China
- The Second Affiliated Hospital Zhejiang University School of MedicineHangzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- iCamuno Biotherapeutics Ltd.
- Trial code
- NCT06821529
- Record updated
- 12 February 2025
- Original description
Parkinson's disease is a progressive neurodegenerative disorder characterized by high morbidity due to the limited regenerative capacity of dopaminergic neurons in the brain. Current drug treatments primarily manage symptoms but do not halt or reverse neuronal loss. Cellular replacement therapy has emerged as a potential strategy to restore dopaminergic function and address the underlying neuronal deficits. This study aims to evaluate the safety, feasibility, and efficacy of transplanting dopaminergic neurons into the brain to improve motor function and quality of life in patients with advanced Parkinson's disease.Read full original descriptionShow less
Stereotactic Intracerebral Injection of Autologous Induced Pluripotent Stem Cell-derived Dopamine Progenitor Cells in Patients with Parkinson's Disease
Parkinson's disease is a progressive neurodegenerative disorder characterized by high morbidity due to the limited regenerative capacity of dopaminergic neurons in the brain. Current drug treatments primarily manage symptoms but do not halt or reverse neuronal loss. Cellular replacement therapy has emerged as a potential strategy to restore dopaminergic function and address the underlying neuronal deficits. This study aims to evaluate the safety, feasibility, and efficacy of transplanting dopaminergic neurons into the brain to improve motor function and quality of life in patients with advanced Parkinson's disease.
Inclusion: Able to sign informed consent and comply with the study protocol; 39-75 years of age, at the time of signing informed consent; Diagnosed to be Parkinson's disease patients over 5 years; Taking levodopa, but with complications of therapy such as wearing off and/or dyskinesia; At least 3 hours accumulative "off" time per day; Hoehn and Yahr Stage 2.5 - 4 in the off state at screening; Dopamine drug responsiveness demonstrated by a positive "on/off" test with at least a 30% improvement on UPDRS III (motor) scale.
Exclusion: Patients with the following concomitant conditions or disorders: Epilepsy；Multiple sclerosis；Unable to give consent due to dementia；Atypical Parkinsonism；Genetic Parkinson's disease；Suicidal ideation associated with intent or plan in the past 12 months；History of psychosis；History of subarachnoid hemorrhage；History of stroke or transient ischemic attack; Patient with unstable vital sign at screening and/or prior to the surgery:; Received cell or gene therapy (autologous or allogeneic) within the previous 12 months; Patients with autoimmune disorders; Patients with HIV and/or active HBV or HCV; Patients who have had active malignancies; Patients who have history of pallidotomy or thalamotomy or deep brain stimulation (DBS) surgery; Other conditions that researchers consider not suitable to participate in this study; Estimated Glomerular Filtration Rate (eGFR) < 60 ml/min/1.73m2; Liver dysfunction, as evidenced by enzymes (AST and ALT) greater than three times the ULN; Hematologic abnormality: hemoglobin <10 mg/dL or platelet count < 100,000/mL; International normalized ratio (INR) ≥ 1.3 not due to a reversible cause; Patients who are unable to undergo MRI and PET/CT; Patients with an expected life expectancy of <1 year; Patients currently receive levodopa-carbidopa intestinal gel or apomorphine treatment; Participation in an investigational therapeutic or device trial within 30 days of consent; Women who are pregnant or breast-feeding.