Stereotactic Intracerebral Injection of IPSC-DAPs in Patients with Parkinson's Disease

Launched by ICAMUNO BIOTHERAPEUTICS LTD. · Feb 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients with advanced Parkinson's disease, a condition that affects movement and can lead to severe disability. The researchers want to see if transplanting special cells called dopaminergic neurons into the brain can help improve motor function and quality of life. Currently, treatments mainly relieve symptoms but do not stop the disease from progressing. This trial will evaluate how safe and effective this new approach is, with the hope that it could lead to better options for people living with Parkinson's.

To be eligible for this study, participants must be between 39 and 75 years old, have been diagnosed with Parkinson's disease for at least five years, and currently experience complications from their medication, such as fluctuations in their symptoms. They should also have significant "off" time, meaning times when their medication is not working well. Participants will be monitored closely throughout the trial to assess the treatment's safety and effectiveness. It's important to note that certain health conditions and treatments may exclude someone from participating, so potential participants will need to discuss their specific situation with the researchers.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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:
• • 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 with autoimmune disorders
• • Patients with HIV and/or active HBV or HCV
• • Patients who are unable to undergo MRI and PET/CT
• • Patients with an expected life expectancy of \<1 year
• • Patients who have had active malignancies
• • Patients currently receive levodopa-carbidopa intestinal gel or apomorphine treatment
• • Patients who have history of pallidotomy or thalamotomy or deep brain stimulation (DBS) surgery
• • Received cell or gene therapy (autologous or allogeneic) within the previous 12 months
• • Participation in an investigational therapeutic or device trial within 30 days of consent
• • Women who are pregnant or breast-feeding
• • Other conditions that researchers consider not suitable to participate in this study