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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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.

A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Feasibility, and Preliminary Efficacy of NouvNeu001 in Patients With Advanced Parkinson's Disease.

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. (NCT07102342) is a Phase 1 interventional studying Parkinson Disease, sponsored by iRegene Therapeutics Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is a phase 1 clinical study to evaluate the safety, tolerability, feasibility, and preliminary efficacy of NouvNeu001 in patients with advanced Parkinson's Disease.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Parkinson Disease, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 5 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: Age • Male or female patient must be 30 to 75 years of age inclusive, at the time of signing the willing to sign a consent form 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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, 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 * Able to understand the rationale of the clinical trial and sign the ICF. Other Inclusion Criteria * 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 Criteria: 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. * 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. Other Exclusion Criteria * 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

Treatments Being Tested

BIOLOGICAL

Human Dopaminergic Progenitor Cells

Single injection of Human Dopaminergic Progenitor Cells into the biliteral putamen/striatum regions of the brain

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Cornell University Weill Medical College
New York, New York, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07102342), the sponsor (iRegene Therapeutics Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07102342 clinical trial studying?

This is a phase 1 clinical study to evaluate the safety, tolerability, feasibility, and preliminary efficacy of NouvNeu001 in patients with advanced Parkinson's Disease. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07102342?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07102342?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07102342. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07102342. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.