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Tests treatment safety and results for Early-onset Parkinson's Disease
Official title The Safety, Tolerability and Preliminary Efficacy of NouvNeu001 for Early-onset Parkinson's Disease
ClinicalTrials.gov ID: NCT06608355
What this study is testing
What is Human Dopaminergic Progenitor Cells?
Human Dopaminergic Progenitor Cells is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for early-onset parkinson's disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn about the safety of NouvNeu001 injection in Early-onset Parkinson's Disease (EOPD) patients. It will also learn about the effects of NouvNeu001 treatment.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Age 18-70 years old, male or female
- Able to understand the rationale of the clinical trial and sign informed consent form (ICF)
- Diagnosis of Early-onset Parkinson's Disease in accordance with the MDS clinical diagnostic criteria for Parkinson's disease, and the age of onset...
- Medically suitable for neurosurgery under anesthesia and able to participate in Computed Tomography (CT)/Magnetic Resonance Imaging (MRI) scan.
- Hoehn-Yahr staging for "off" episodes is 2 to 4
You likely can't join if
- Atypical Parkinsonism
- Patients who have had previous pallidotomy, striatal or extrapyramidal surgery or other brain surgery; as well as other surgical procedures that are...
- Patients who have a previous head CT/MRI examination showing cerebral trauma, vascular malformation, hydrocephalus, brain tumor, etc., and patients...
- Patients with a history of severe cardiovascular and cerebrovascular diseases
- Patients with a history of malignant tumors
- Patients who have received stem cell therapy for Parkinson's disease within 2 years before signing the ICF
See the full eligibility criteria
- Age 18-70 years old, male or female
- Able to understand the rationale of the clinical trial and sign informed consent form (ICF)
- Diagnosis of Early-onset Parkinson's Disease in accordance with the MDS clinical diagnostic criteria for Parkinson's disease, and the age of onset was ≤50 years old
- Medically suitable for neurosurgery under anesthesia and able to participate in Computed Tomography (CT)/Magnetic Resonance Imaging (MRI) scan.
- Hoehn-Yahr staging for "off" episodes is 2 to 4
- The MDS-UPDRS-III score in the "off" state \>30, and positive for the Acute Levodopa Challenge Test (ALCT)
- Acceptable laboratory test results during screening and prior to transplantation
- Atypical Parkinsonism
- Patients who have had previous pallidotomy, striatal or extrapyramidal surgery or other brain surgery; as well as other surgical procedures that are judged by the investigator to affect patient's participation in this...
- 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...
- Patients with a history of severe cardiovascular and cerebrovascular diseases
- Patients with a history of malignant tumors
- Patients who have received stem cell therapy for Parkinson's disease within 2 years before signing the ICF
- 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...
- 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
- Patients with active epilepsy or currently on anti-epileptic drugs
- Patients with a history of dementia or severe cognitive disorder, or the score of MDS-UPDRS 1.1 during screening is \> 3; poor compliance, inability to accurately keep diary, and/or inability to sign ICF due to dementia
- Patients with severe depression or with severe anxiety
- Patients with the following abnormalities during screening, including: Abnormal coagulation; Abnormal immunological tests, and assessed by the investigator it is not suitable to participate in the trial; Hypertensive...
- Patients with other combined severe systemic diseases, such as pulmonary heart disease, 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...
- Patients with alcohol addiction or positive for drug of abuse testing
- Patients with a history of contraindication or allergy to the drugs used during the study or any of its components, or are allergic to the same drugs or other macrolides, or have allergies
- Female of childbearing potential who are not surgically sterilized/premenopausal/unwilling to use medically approved effective contraception with 2 years after administration of investigational drug and lactating women...
- 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 in other clinical studies and received intervention therapy within 3 months prior to the surgery
- Patients with poor compliance based on clinical evaluation of the investigator
- Patients who are being treated with drugs such as apomorphine, or levodopa/carbidopa infusion therapy
- Patients with severe dyskinesia in both on- and off-drug states
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.