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

Last updated: October 30, 2024
Sponsor: iRegene Therapeutics Co., Ltd.
Overall Status: Active - Recruiting

Phase

1/2

Condition

N/A

Treatment

Human Dopaminergic Progenitor Cells

Clinical Study ID

NCT06167681
NouvNeu001-02
  • Ages 50-75
  • All Genders

Study 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 Parkinson's disease.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 50-75 years old, male or female

  • Able to understand the rationale of the clinical trial and sign informed consentform (ICF)

  • Diagnosis of Parkinson's Disease in accordance with the MDS clinical diagnosticcriteria 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 inMagnetic 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 positivefor the Acute Levodopa Challenge Test (ALCT)

  • Acceptable laboratory test results during screening and prior to transplantation

Exclusion

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 wellas other surgical procedures that are judged by the investigator to affect patient'sparticipation 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 brainimaging abnormalities in the striatum or other brain areas leading to asignificantly 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 significanthemorrhagic tendency within 3 months prior to screening, or who cannot temporarilysuspend anti-platelet agents or other anti-coagulant medications for at least 5 daysbefore surgery

  • Patients with long-term, heavy use of glucocorticoids or immunosuppressive drugswithin 3 months prior to signing the ICF

  • Patients with a history of mental illness who are deemed unfit to participate in thestudy by the investigator; or a history of suicidal ideation or suicide attemptswithin 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 ofMDS-UPDRS 1.1 during screening is > 3; poor compliance, inability to accurately keepdiary, 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: Abnormalcoagulation; Abnormal immunological tests, and assessed by the investigator it isnot suitable to participate in the trial; Hypertensive patients with poorlycontrolled blood pressure and patients with severe postural hypotension; Diabeticpatients with poorly controlled blood glucose

  • Patients with surgical contraindications, or with other surgical procedures within 6months before screening which, in the opinion of the investigator, have an impact onthis trial; Patients with other neurosurgical contraindications

  • Patients with other combined severe systemic diseases, such as pulmonary heartdisease, 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 > detectionof normal values; Tuberculosis is in the active stage; Other active infections thatthe investigator believes may affect Patients' participation in the study or affectstudy 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 thestudy or any of its components, or are allergic to the same drugs or othermacrolides, or have allergies;

  • Female of childbearing potential who are not surgicallysterilized/premenopausal/unwilling to use medically approved effective contraceptionwith 2 years after administration of investigational drug and lactating women; menwho are not surgically sterilized/unwilling to use medically approved effectivecontraception 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 inother clinical studies and received intervention therapy within 3 months prior tothe surgery

  • Patients with poor compliance based on clinical evaluation of the investigator

  • Patients who are being treated with drugs such as apomorphine, or levodopa/carbidopainfusion therapy

  • Patients with severe dyskinesia in both on- and off-drug states

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Human Dopaminergic Progenitor Cells
Phase: 1/2
Study Start date:
January 17, 2024
Estimated Completion Date:
July 31, 2029

Study 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 prevent potential immune rejection for 24 to 36 weeks.

Connect with a study center

  • Beijing Hospital

    Beijing, Beijing 100730
    China

    Active - Recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei 430071
    China

    Site Not Available

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