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.
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 of two screening period visits.
No significant change in UPDRS-III scores between the two visits during the screening period.
Atypical Parkinsonism (Parkinsonism-Plus syndrome, secondary parkinsonism, familial parkinsonism) Prior/Concomitant Therapy
Patients who have had previous pallidotomy, DBS surgery, striatal or extrapyramidal surgery, brain stereotaxy, prior surgical or radiation therapy to the brain or spinal cord, or other brain surgery; as well as other surgical procedures that, in the investigator's judgment, could interfere with participation in this study.
Patients who have a previous head CT/MRI examination showing cerebral trauma, vascular malformation, hydrocephalus, brain tumor, etc., and patients who have brain imaging abnormalities in the striatum or other brain areas leading to a significantly increased risk for surgery.
Patients who have had previous cellular therapy.
Single group
Human Dopaminergic Progenitor Cells
Biological/VaccineSingle injection of Human Dopaminergic Progenitor Cells into the biliteral putamen/striatum regions of the brain
Safety and Tolerability
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).
The Motor Function and Non-motor Function
Changes in MDS-UPDRS Part I-IV Score from baseline to 48 weeks and 96 weeks post-transplant. A higher score indicates more severe symptoms or worse health.
Continued Safety and Tolerability
Incidence and severity of AEs and SAEs within 96 weeks and 15 years post-transplant.
Click on the lead sponsor to view all of their trials.
