NouvNeu001 for Parkinson's Disease
This study is testing a new treatment called NouvNeu001, which involves injecting human dopaminergic progenitor cells into specific areas of the brain, for people with Parkinson's disease. Researchers want to see if this treatment is safe, how well people tolerate it, and if it shows any early signs of helping. You might be able to join if you are between 30 and 75 years old and have had Parkinson's disease for 4 to 20 years, with a certain level of motor symptoms (H-Y staging 2.5-4.0 during "OFF" episodes). The main goals are to check for safety and how well people tolerate the treatment for up to 48 weeks after the injection. This study is currently recruiting a small number of participants (5 people).
- Study design
- This is an early-stage (Phase 1/2), single-arm study, meaning all 5 participants will receive the NouvNeu001 treatment. It is also open-label, so both you and the study team will know which treatment you are receiving.
- What's involved
- You would receive a single injection of NouvNeu001 into your brain and then take medications to prevent immune rejection for 24 to 36 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety and tolerability will be checked at 24 weeks and 48 weeks after the injection.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07102342
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
PHASE1Ages 30–75InterventionalTreatmentiRegene Therapeutics Co., Ltd.
~5 participants
Updated 2026-05-11 on ClinicalTrials.gov
What's tested:Human Dopaminergic Progenitor Cells
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Tolerability
Measured over 24 weeks and 48 weeks post-transplant
Conditions
NCT07102342
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Cornell University Weill Medical College
New York, New Yorkno site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Eligibility criteria
Inclusion
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.
Agree not to receive COVID-19 vaccine within 14 days before neurosurgery, and not to receive any other vaccine within 30 days after neurosurgery
Exclusion
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.
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.
subarachnoid hemorrhage
primary mitochondrial disorder, multiple sclerosis, or other neurodegenerative diseases such as Alzheimer's disease
major vascular diseases (aortic aneurysm, aortic dissecting aneurysm, internal carotid artery stenosis), as determined by the investigator to be unsuitable to participate the study.
previous or current malignant tumors
immune disfunction, including autoimmune disease or immunocompromised state
traumatic brain injury with loss of consciousness and residue neurologic symptoms
active epilepsy or currently on anti-epileptic drugs
Hypertensive patients with poorly controlled blood pressure (defined as blood pressure above 160/100 mmHg despite antihypertensive drugs treatment) and patients with severe postural hypotension
Diabetic patients with poorly controlled blood glucose (glycosylated hemoglobin \> 9.0%, or fasting plasma glucose (FPG) ≥ 11.1mmol/L)
Patients with clinically significant abnormalities in kidney or liver function at screening.
Patient with clinically significant abnormalities in immunological tests at screening
Patients with surgical contraindications (such as those with cochlear implant, cardiac pacemaker, cardiac defibrillator, stereotactic nucleus pallidotomy; Patients who have had unilateral or bilateral intraparenchymal implantation of cellular products, or other surgical procedures within 6 months before screening which, in the opinion of the investigator, have an impact on this trial; Patients with other neurosurgical contraindications)
Patients with other combined severe systemic diseases, such as pulmonary heart disease, moderate to severe asthma, severe chronic obstructive pulmonary disease (COPD) (FEV1% \< 50%)
Patients with serious infections, requiring antibiotic treatment within 2 weeks prior to signing the ICF
Patients with any active infectious disease, including but not limited to positive for human immunodeficiency virus, SARS Covid-19 virus, syphilis antibody, quantitative HCV-RNA testing, quantitative HBV-DNA testing greater than normal range for test results, or untreated tuberculosis; any other active infection that, in the investigator's opinion, may affect the participant's ability to take part in the study or could impact study outcomes.
Patients with alcohol or drug addiction
Patients with contraindications or a history of allergy to any medicines used during the neurosurgical procedure.
Patients with contraindication or a history of allergy to any medicines used during the study, such as immunosuppressants, levodopa, etc, or any of their components; Patients who are allergic to similar drugs or other macrolides.
Female of childbearing potential who are not surgically sterilized/premenopausal/unwilling to use medically approved effective contraception during the study and lactating women; men who are not surgically sterilized/unwilling to use medically approved effective contraception during the study
Patients who have received electric shock therapy within 30 days prior to the investigational drug administration surgery
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
Patients who are being treated with drugs such as neuroleptics, apomorphine, or levodopa/carbidopa infusion therapy
Patients with severe dyskinesia in both "ON" and "OFF" drug states
Patients who have received or will receive a live vaccine within 4 weeks prior to the study
Patients with significant medical conditions, or with other conditions that, in the opinion of the investigator, are unsuitable to participate in the study
What this trial measures
- Safety and Tolerability24 weeks and 48 weeks post-transplant
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).