iRegene Therapeutics Co., Ltd.
This is a phase 1/2 clinical study to evaluate the safety, tolerability, feasibility, and preliminary efficacy of NouvNeu001 in patients with advanced Parkinson's Disease.
This is a multi-center, single arm, and open label trial. The NouvNeu001 will be transplanted into the bilateral putamen/striatum using stereotactic neurosurgery. Subjects will take immunosuppressants to prevent potential immune rejection for 24 to 36 weeks.
Inclusion Criteria: Age • Male or female patient must be 30 to 75 years of age inclusive, at the time of signing the informed consent form (ICF). Type of Patient and Disease Characteristics * Diagnosis of PD between past 4 to 20 years (meet MDS 2015 clinical diagnostic criteria for PD). * H-Y staging (Appendix III) for "OFF" episodes is 2.5-4.0. * MDS-UPDRS-III score \> 35, and positive for the Acute levodopa challenge test (ALCT) (improvement \> 30% for MDS UPDRS-III staging from OFF episodes to ON episodes) over two screening period visits. Baseline scores will be computed as the means o…
Single injection of Human Dopaminergic Progenitor Cells into the biliteral putamen/striatum regions of the brain
Arctuva estimate
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