Loading clinical trials...

The Safety, Tolerability and Efficacy of NouvNeu001 for Parkinson's Disease | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

A Phase I/II Study to Assess the Safety, Tolerability and Efficacy of NouvNeu001 Injection for Mid- to Late-stage Parkinson's Disease

NCT06167681•iRegene Therapeutics Co., Ltd.

View on ClinicalTrials.gov

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.

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 prevent potential immune rejection for 24 to 36 weeks.

Eligibility

Age

50 - 75 years

Sex

ALL

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)
•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
+15 more criteria

Locations (2)

Beijing Hospital

Beijing, Beijing Municipality, China

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Key Dates

Start Date

January 17, 2024

Primary Completion Date

December 1, 2025

Completion Date

July 1, 2029

Last Updated

November 1, 2024

Enrollment

ESTIMATED participants

Conditions

Parkinson Disease

Interventions

Human Dopaminergic Progenitor Cells

BIOLOGICAL

Contacts

Meng Cai, Ph.D

CONTACT

0086-027-59337986 caimeng@iregene.com

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

NCT06692920

Parkinson Disease

View study

RECRUITINGPHASE1

[18F]F-DOPA Imaging in Patients With Autonomic Failure

NCT04246437

Autonomic FailurePure Autonomic Failure+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 1, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

[18F]F-DOPA Imaging in Patients With Autonomic Failure

Montelukast in Parkinson Disease

Exercise for Cognitive Excellence in Parkinson's Disease

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations

The Effect of Functional Rotational Exercises on Fall Risk and Mobility in Parkinson's Disease Patients