NCT07212088Not yet recruitingPhase 1
Stereotactic Intracerebral Injection of Allogenic IPSC-DAPs in Patients With Parkinson's Disease
Stereotactic Intracerebral Injection of Allogenic Induced Pluripotent Stem Cell-derived Dopamine Progenitor Cells in Patients With Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 11 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 30 Sept 2025
- Start date
- 28 Feb 2026
- Primary completion date
- 15 Dec 2027
- Lead sponsor
- iCamuno Biotherapeutics Ltd.
- Diseases
- Parkinson disease
- NCT number
- NCT07212088
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 12
- From 28 Feb 2026 to the primary completion date, 15 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- 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
Other
- 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
Who the study is looking for
- Able to sign informed consent and comply with the study protocol
- 55-75 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 3 - 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
Age in the registry: 55 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Second Affiliated Hospital, Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.