Recruiting · registry statusTesting a cell treatment for Parkinson’s
Researchers investigate the safety, tolerability and early effects of NouvNeu001, an injection of developing cells intended to produce dopamine.
Testing a treatment or activity · Study reference: NCT06167681
Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓
This registry record was last updated over six months ago, or its update date is missing. Recruitment may have changed. Confirm with the team before making plans.
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Looking for volunteers
- Start (reported actual date)
- 2024-01-17
- Main measurements finished (planned)
- 2025-12
- Study finished (planned)
- 2029-07
Planned dates can move. A study finishing does not tell us when a paper will be published.
No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.
Changes we have recorded
These are dates we observed a change, not necessarily the dates it happened.
Papers connected to this study
No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.
Who can join?
Ages 50 years to 75 years · Does not accept healthy volunteers
These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.
Read all the rules for taking part
Sex eligibility reported by registry: all
Inclusion Criteria:
* Age 50-75 years old, male or female
* Able to understand the rationale of the clinical trial and sign informed consent form (ICF)
* Diagnosis of Parkinson's Disease in accordance with the MDS clinical diagnostic criteria for Parkinson's disease (2015)
* Diagnosis of Parkinson's Disease made between 4 to 20 years ago
* Medically suitable for neurosurgery under anesthesia and able to participate in Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET) scan.
* Hoehn-Yahr staging for "off" episodes is 2.5 to 4
* The MDS-UPDRS Part III (MDS-UPDRS-III) score in the "off" state \> 35, and positive for the Acute Levodopa Challenge Test (ALCT)
* Acceptable laboratory test results during screening and prior to transplantation
Exclusion Criteria:
* Atypical Parkinsonism
* Patients who have had previous pallidotomy, deep brain stimulation (DBS) surgery, striatal or extrapyramidal surgery, brain stereotaxy or other brain surgery; as well as other surgical procedures that are judged by the investigator to affect patient's 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 with a history of severe cardiovascular and cerebrovascular diseases
* Patients with a history of malignant tumors
* Patients who have had previous cellular therapy
* Patients with active disseminated intravascular coagulation and significant hemorrhagic tendency within 3 months prior to screening, or who cannot temporarily suspend anti-platelet agents or other anti-coagulant medications for at least 5 days before surgery
* Patients with long-term, heavy use of glucocorticoids or immunosuppressive drugs within 3 months prior to signing the ICF
* Patients with a history of mental illness who are deemed unfit to participate in the study by the investigator; or a history of suicidal ideation or suicide attempts within the past year or currently;
* Patients who have used botulinum toxin within 6 months prior to signing the ICF
* Patients with active epilepsy or currently on anti-epileptic drugs
* Patients with a history of dementia or severe cognitive disorder, or the score of MDS-UPDRS 1.1 during screening is \> 3; poor compliance, inability to accurately keep diary, and/or inability to sign ICF due to dementia
* Patients with severe depression or with severe anxiety during screening;
* Patients with the following abnormalities during screening, including: Abnormal coagulation; Abnormal immunological tests, and assessed by the investigator it is not suitable to participate in the trial; Hypertensive patients with poorly controlled blood pressure and patients with severe postural hypotension; Diabetic patients with poorly controlled blood glucose
* Patients with surgical contraindications, or with 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)
* Presence of one of the following: positive for human immunodeficiency virus (HIV) antibody, treponema pallidum antibody, hepatitis C virus (HCV) antibody and HCV RNA; Hepatitis B virus (HBV) surface antigen positive and HBV DNA copy number \> detection of normal values; Tuberculosis is in the active stage; Other active infections that the investigator believes may affect Patients' participation in the study or affect study outcomes;
* Patients with alcohol addiction or positive for drug of abuse testing
* Patients with a history of contraindication or allergy to the drugs used during the study or any of its components, or are allergic to the same drugs or other macrolides, or have allergies;
* Female of childbearing potential who are not surgically sterilized/premenopausal/unwilling to use medically approved effective contraception with 2 years after administration of investigational drug and lactating women; men who are not surgically sterilized/unwilling to use medically approved effective contraception with 2 years after administration of investigational drug
* Patients who have received electric shock therapy within 30 days prior to surgery
* Patients who are participating in other clinical trials, or have been enrolled in other clinical studies and received intervention therapy within 3 months prior to the surgery
* Patients with poor compliance based on clinical evaluation of the investigator
* Patients who are being treated with drugs such as apomorphine, or levodopa/carbidopa infusion therapy
* Patients with severe dyskinesia in both on- and off-drug states
Full study name & original research details
Official study title
A Phase I/II Study to Assess the Safety, Tolerability and Efficacy of NouvNeu001 Injection for Mid- to Late-stage Parkinson's Disease
Short title used by the registry
The Safety, Tolerability and Efficacy of NouvNeu001 for Parkinson's Disease
Original description
This clinical trial is designed to evaluate the safety, tolerability and preliminary efficacy of a single injection of NouvNeu001 (Human Dopaminergic Progenitor Cells Injection) in patients with Parkinson's disease.
Further description from the registry
This is a multi-center, single arm, and open label trial. The NouvNeu001 will be transplanted into bilateral putamen/striatum using stereotactic neurosurgery. Subjects will take immunosuppressants to prevent potential immune rejection for 24 to 36 weeks.
Conditions reported: Parkinson Disease
Registry records for this study
Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.
- Study type
- Interventional
- Interventions
- Human Dopaminergic Progenitor Cells
- Phases
- PHASE1; PHASE2
- Sponsor
- iRegene Therapeutics Co., Ltd.
- Start date reported by registry
- 2024-01-17 (actual)
Registry updated: 2024-11-01 · Status last verified by the registry submitter: 2024-07
Registry records retrieved 2026-10-13 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.
Contact the research team
Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.
Meng Cai, Ph.D · 0086-027-59337986 · caimeng@iregene.com
Study locations
Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.
Beijing Hospital
Beijing, Beijing Municipality, China
RecruitingHaibo Chen · chenhbneuro@263.net
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Not yet recruitingNanxiang Xiong · mozhuoxiong@163.com
Facility not reported
China
Status not reportedThe original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.