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New treatment option for Multiple System Atrophy - Parkinsonian Subtype (MSA-P)
Official title A Phase I/III Clinical Study to Evaluate NouvNeu001 Injection for Multiple System Atrophy
ClinicalTrials.gov ID: NCT07289477
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 multiple system atrophy - parkinsonian subtype (msa-p).
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
- 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 Multiple System Atrophy.
- 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 30 to 70
You may be able to join if
- Aged between 30 and 70 years (inclusive), regardless of gender.
- The subject understands and agrees to comply with the study procedures and voluntarily provides written informed consent.
- Diagnosed with pathologically confirmed, clinically established, or clinically probable Multiple System Atrophy (MSA) according to the 2022 MDS...
- Current treatments for core MSA symptoms are inadequately controlled.
- The duration of MSA-related motor symptoms (parkinsonism and/or cerebellar ataxia) is no more than 5 years.
You likely can't join if
- Neurological diseases/disorders other than Multiple System Atrophy, such as Parkinson's disease, Dementia with Lewy Bodies, Essential Tremor...
- Diagnosis of dementia.
- Previous or current receipt of other disease-modifying therapies, or participation in clinical trials of other new drugs or novel therapies.
- Use of medications within the past 3 months that may affect Parkinsonian symptoms, autonomic function, or the evaluation of safety.
- Presence of clinically significant or unstable medical or surgical conditions that may preclude the safe completion of the treatment or confound the...
- History of or undergoing treatment for recurrent stroke.
See the full eligibility criteria
- Aged between 30 and 70 years (inclusive), regardless of gender.
- The subject understands and agrees to comply with the study procedures and voluntarily provides written informed consent.
- Diagnosed with pathologically confirmed, clinically established, or clinically probable Multiple System Atrophy (MSA) according to the 2022 MDS diagnostic criteria.
- Current treatments for core MSA symptoms are inadequately controlled.
- The duration of MSA-related motor symptoms (parkinsonism and/or cerebellar ataxia) is no more than 5 years.
- Ability to walk without human assistance, defined as being able to take at least 10 steps; the use of assistive devices (e.g., a walker or cane) is permitted.
- Life expectancy of at least 3 years.
- The subject agrees not to participate in any other clinical studies for 24 months following the investigational product administration.
- Neurological diseases/disorders other than Multiple System Atrophy, such as Parkinson's disease, Dementia with Lewy Bodies, Essential Tremor, Progressive Supranuclear Palsy, Spinocerebellar Ataxia, Hereditary Spastic...
- Diagnosis of dementia.
- Previous or current receipt of other disease-modifying therapies, or participation in clinical trials of other new drugs or novel therapies.
- Use of medications within the past 3 months that may affect Parkinsonian symptoms, autonomic function, or the evaluation of safety.
- Presence of clinically significant or unstable medical or surgical conditions that may preclude the safe completion of the treatment or confound the treatment outcomes.
- History of or undergoing treatment for recurrent stroke.
- Screening brain MRI shows other significant pathological findings, including but not limited to: cerebral hemorrhage, acute cerebral infarction, aneurysm, vascular malformation, infectious lesions, brain tumors, or...
- people meeting any of the following criteria indicating advanced disease: Speech impairment defined by a score of ≥3 on UMSARS Item 1. Swallowing impairment defined by a score of ≥3 on UMSARS Item 2. Walking impairment...
- History of current substance abuse and/or alcohol abuse (within 12 months prior to screening).
- Known allergy to the investigational product(s); or history of allergy to antibiotics or other drugs.
- Positive screening results for active viral infection, including Human Immunodeficiency Virus (HIV), Hepatitis B Surface Antigen (HBsAg), Hepatitis B Core Antibodies, or Hepatitis C Virus (HCV).
- Severe hepatic insufficiency, renal insufficiency, or severe cardiac insufficiency: Severe hepatic insufficiency: ALT ≥ 2.0 × upper limit of normal (ULN) or AST ≥ 2.0 × ULN. Severe renal insufficiency: Serum creatinine...
- History of thrombocytopenia within the past three months, other bleeding disorders, or current receipt of anticoagulant therapy (excluding aspirin at a dose ≤ 100 mg per day).
- Pregnancy, lactation, or planning pregnancy.
- History of Bipolar Disorder, Major Depressive Disorder, Schizophrenia, or other psychotic disorders.
- people judged by the investigator to have suicidal ideation at screening, or a suicide attempt within 6 months prior to screening.
- Contraindications for surgery (e.g., implantation of cochlear implants, pacemakers, defibrillators, history of stereotactic ablation, previous implantation of unilateral/bilateral similar products) or history of other...
- Clinically significant cardiac disease defined as: myocardial infarction, NYHA Class III or IV heart failure, uncontrolled coronary spasm, severe uncontrolled ventricular arrhythmia, or evidence of acute ischemia or...
- Diagnosis of malignancy.
- Family history of congenital or inherited immunodeficiency disorders.
- Considered by the investigator to have poor compliance.
- Any other significant disease or condition that, in the investigator's judgment, may jeopardize the subject's safety or interfere with the study assessments.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, 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, 30 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, 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.