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
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)
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
Treatments tested in this trial
- Human Dopaminergic Progenitor Cells
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov