Status:
RECRUITING
The Safety, Tolerability and Efficacy of NouvNeu001 for Parkinson's Disease
Lead Sponsor:
iRegene Therapeutics Co., Ltd.
Conditions:
Parkinson Disease
Eligibility:
All Genders
50-75 years
Phase:
PHASE1
PHASE2
Brief Summary
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 Parki...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2029
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06167681
Start Date
January 17 2024
End Date
July 1 2029
Last Update
November 1 2024
Active Locations (2)
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1
Beijing Hospital
Beijing, Beijing Municipality, China, 100730
2
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430071