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.

Recruiting now · Phase 1/Phase 2

Conditions studied: Parkinson Disease

In brief

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.

Key facts

Study ID

NCT07102342

Run by

iRegene Therapeutics Co., Ltd.

People needed

5

Starts

2026-01-12

Expected to finish

2032-09-01

Last updated by the study team

2026-05-11

Who can join

Age: 30 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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, until completion of the 12-month follow-up study (unless recommended by a neurologist).
• Agree not to participate in any other therapeutic intervention study within 24 months after neurosurgery.
• Able to participate in all study visits and evaluations, including brain/spine MRI, CT and PET scan.
• Weight • Body mass index (BMI) within the range of 18\~32 kg/m2 (inclusive) with a minimum body weight of 45 kg at screening.
• Sex and Contraceptive/Barrier Requirements
• Contraceptive use by men and women for 12 months after neurosurgery should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Informed Consent

You may not qualify if…

• Medical Conditions
• 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.
• Patients who have used glucocorticoids for an extended period (≥14 days) and at high doses (equivalent to prednisone ≥ 20 mg/day or other glucocorticoids at equivalent doses) within 3 months prior to signing the ICF. (excluding topical treatment)
• Patients who have used immunosuppressive drugs for an extended period (≥14 days) within 3 months prior to signing the ICF.
• Patients who have used antipsychotics, such as antidepressants, antimanic drugs, etc. within 3 months prior to signing the ICF and are deemed by the investigator to potentially impact the study assessment.
• Patients who have used botulinum toxin or other drugs for dystonia or muscle spasticity within 6 months prior to signing the ICF and are deemed by the investigator to potentially impact the study assessment.
• Prior/Concurrent Clinical Study Experience
• Patients who are participating in other clinical trials, or have been enrolled in other clinical studies within 3 months prior to the screening
• Patients with poor compliance based on clinical evaluation of the investigator. Diagnostic Assessments
• Patients with a history of dementia or a severe cognitive disorder; or those with obvious dementia or congnitive impairment detected during screening; MDS-UPDRS congnitive impairment score (section 1.1) > 3 point at screening; or patinets with poor compliance, inability to accurately keep diary, and/or inability to sign ICF due to dementia.
• Severe depression as defined by HAMD ≥ 24 at screening.
• Severe anxiety as defined by HAMA ≥ 29 at screening.
• Patients with a history of psychiatric disorders that, in the investigator's opinion, make them unsuitable for participation; or patients with a history of suicidal ideation or suicide attempts within the past year or currently (including actual attempts, interrupted attempts, or failed attempts).
• Patients with abnormal coagulation (prothrombin time ≥ 1.5 ULN, activated partial thromboplastin time ≥ 1.5 ULN), or abnormal INR at screening.
• Patients cannot temporarily suspend anti-platelet agents or other anti-coagulant medications at least 5 days prior to investigational drug administration surgery.
• Patients with active disseminated intravascular coagulation and significant hemorrhagic tendency within 3 months prior to signing the ICF.
• Patients with current or history of following disease
• severe heart failure (congestive heart failure of New York Heart Association Class II or above), unstable angina pectoris, and myocardial infarction
• severe arrhythmia, including but not limited to second- or third-degree atrioventricular block, or prolonged QT interval.
• Long QT Syndrome.
• cardiovascular surgery (cardiac, vascular stent surgery, angioplasty).
• stroke or transient ischemic attack within 3 months prior to signing the ICF, as determined by the investigator to be unsuitable to participate the study.

Where it is running

• Cornell University Weill Medical College — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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