The Safety, Feasibility and Efficacy of NouvNeu001 for Parkinson's Disease

iRegene Therapeutics

Status and phase

Not yet enrolling

Phase 2

Conditions

Parkinson Disease (PD)

Treatments

Biological: Human Dopaminergic Progenitor Cells

Study type

Interventional

Funder types

Industry

Identifiers

NCT07028632

NouvNeu001-02-

Details and patient eligibility

About

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.

Full description

This is a multi-center, single arm, and open label trial. The NouvNeu001 will be transplanted into bilateral putamen using stereotactic neurosurgery. Subjects will take immunosuppressants to prevent potential immune rejection for 24 to 36 weeks.

Enrollment

30 estimated patients

Sex

All

Ages

50 to 75 years old

Volunteers

No Healthy Volunteers

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)，Parkinson's disease history of ≥ 4 years
Medically suitable for neurosurgery under anesthesia and able to participate in Computerized Tomography (CT) and 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)
Currently undergoing treatment with levodopa drugs, but with poor control of motor symptoms or reduced efficacy
Receive a stable dose of anti-Parkinson's disease drugs for at least 4 weeks before administration
Acceptable laboratory test results during screening and prior to transplantation
The patients agreed to postpone any other elective neurosurgery, including deep brain stimulation (DBS), until the completion of the 24-month follow-up
The patients agreed not to participate in any other interventional clinical studies within 24 months after administration
The patients agreed not to receive any vaccines within 30 days after administration

Exclusion criteria

Atypical or secondary Parkinson's syndrome to be caused by drugs, metabolic disorders or other reasons
The patients who have a previous history of PD-related brain surgery and have been judged by the investigator to pose significant risks or impact the assessment, or patients with contraindications for magnetic resonance imaging, or those who have been assessed by the investigator as having any contraindications for surgery or anesthesia, or patients who have received other surgeries that the investigator consider might affect their participation in this study
There were obvious abnormalities in the cranial CT/MRI examination
Those who have a history of severe cardiovascular diseases within one year prior to screening
Patients with a history of malignant tumors，or those who have received cellular therapy or gene therapy within the five years prior to the screening
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 other combined severe systemic diseases, such as pulmonary heart disease, moderate to severe asthma, severe chronic obstructive pulmonary disease (COPD)
There are human immunodeficiency virus (HIV) infection, syphilis infection, and active hepatitis C virus (HCV) infection, hepatitis B virus (HBV) infection, tuberculosis infection or other active infections that the investigator consider may affect the participation of the patients in the study or affect the study outcome
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 severe dyskinesia in both on- and off-drug states