The Safety, Feasibility and Efficacy of NouvNeu001 for Parkinson's Disease
ConditionParkinson Disease (PD)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50-75
SponsoriRegene Therapeutics Co., Ltd.
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Human Dopaminergic Progenitor Cells
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov