The Safety, Tolerability and Efficacy of NouvNeu001 for Parkinson's Disease
ConditionParkinson Disease
Trial statusRecruiting
Trial phasePhase 1, Phase 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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
Human Dopaminergic Progenitor Cells
Biological/VaccineSingle injection of Human Dopaminergic Progenitor Cells into the putamen/striatum region of brain.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: NouvNeu001Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety and Tolerability
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).
Time frame
24 weeks and 48 weeks post-transplant2
Motor Function
Changes in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part Ⅲ score from baseline to 24 weeks post-transplant. MDS-UPDRS Part III assesses the motor signs of PD, a higher score indicates more severe symptoms of PD.
Time frame
24 weeks post-transplantSecondary outcomes
1
The Motor Function and Non-motor Function
Changes in MDS-UPDRS Part I-IV Score from baseline to 48 weeks and 96 weeks post-transplant. A higher score indicates more severe symptoms or worse health.
Time frame
48 weeks and 96 weeks post-transplant2
Continued Safety and Tolerability
Incidence and severity of AEs and SAEs within 96 weeks and 5 years post-transplant.
Time frame
96 weeks and 5 years post-transplantSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov