This Clinical Trial is Designed to Evaluate the Safety, Tolerability, Feasibility and Preliminary… (NCT07102342) | Clinical Trial Compass
RecruitingPhase 1/2
This Clinical Trial is Designed to Evaluate the Safety, Tolerability, Feasibility and Preliminary Efficacy of NouvNeu001 (Human Dopaminergic Progenitor Cells Injection) in Patients With Parkinson's Disease.
United States5 participantsStarted 2026-01-12
Plain-language summary
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.
Who can participate
Age range30 Years – 75 Years
SexALL
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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 of two screening period visits.
* No significant change in UPDRS-III scores between the two visits during the screening period.
* Patients who take stable doing of dopamine drug for at least 4 weeks prior to receiving the study drug.
* No significant change in dose and dosing schedule of the prescribed medicines for PD during the screening period.
* Medically suitable for neurosurgery under general anesthesia.
* Acceptable laboratory test values during screening and prior to transplantation (Day 0):
* Absolute neutrophil count ≥ 2.0 × 109/L
* White blood cell count ≥ 4.0 × 109/L
* Platelet count ≥ 100 × 109/L
* Aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤ 2.5 x upper limit of normal (ULN)
* Total bilirubin ≤ 1.5 x ULN
* Serum creatinine ≤ 1.5 x ULN
* eGFR ≥ 50 mL/min/1.73 m2
* Agree to postpone any additional neurosurgical procedures, including DBS, unt…