Clinical trial for Parkinson Disease
Official title Treating Parkinson's Disease Through Transplantation of Autologous Stem Cell-Derived Dopaminergic Neurons
ClinicalTrials.gov ID: NCT06687837
What this study is testing
What is Autologous dopaminergic cell implantation?
An investigational procedure that involves injecting a patient’s own stem‑cell derived dopaminergic progenitor cells into the brain to study its potential for treating 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 study wants to find out if putting dopaminergic cells into the brain is safe and tolerable for people with Parkinson’s disease.
- Who it's for
- It is looking for people who have Parkinson’s disease.
- What's involved
- Participants will have a surgery that puts stem‑cell derived brain cells, made from their own skin, into their brain. They will also have follow‑up visits and tests to monitor safety.
- Time commitment
- The study lasts about a year, with several hospital visits for surgery, follow‑up exams, and safety monitoring.
- 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 45 to 80
You may be able to join if
- Diagnosis of Parkinson's Disease consistent with the Movement Disorders Society 2015 Parkinson's diagnostic criteria.
- Age 45 - 80 years
- English proficiency sufficient to understand the consent form and participate in a discussion of risks and benefits
- At least 5 years since Parkinson's disease motor symptom onset
- Modified Hoehn and Yahr stage 3-4 in "off"-medication state
You likely can't join if
- people unable to give consent due to dementia or psychosis.
- Montreal Cognitive Assessment (MoCA) score \< 26
- people with a first-degree relative with Parkinson's disease or with a known genetic mutation predisposing to the development of Parkinson's disease...
- Atypical Parkinsonism (Parkinson's-Plus syndrome, secondary parkinsonism)
- Moderate or severe levodopa-induced dyskinesias in any body segment (such patients were found to be more prone to graft-induced dyskinesias in the...
- Neurologic history or imaging demonstrating brain pathology not directly related to Parkinson's disease that is likely to interfere with study...
See the full eligibility criteria
- Diagnosis of Parkinson's Disease consistent with the Movement Disorders Society 2015 Parkinson's diagnostic criteria.
- Age 45 - 80 years
- English proficiency sufficient to understand the consent form and participate in a discussion of risks and benefits
- At least 5 years since Parkinson's disease motor symptom onset
- Modified Hoehn and Yahr stage 3-4 in "off"-medication state
- Motor symptoms responsive to levodopa and/or dopamine agonist, defined as taking at least 300 mg/day of levodopa and exhibiting improvement between "off" and "on" MDS-UPDRS of at least 30%
- At least 3 hours of cumulative "off" time per day
- Stable regimen of Parkinson's medications, including levodopa and dopamine agonists, for at least 4 weeks prior to screening.
- Platelets \> 100×109/L (transfusion independent)
- Prothrombin time / partial thromboplastin time in normal range and international normalized ratio ≤ 1.3
- Aspartate aminotransferase and alanine aminotransferase \< 2.5x the upper limit of normal
- Serum creatinine ≤ 1.5mg/dL
- White blood cell count \< 12×109/L.
- Estimated glomerular filtration rate ≥ 30 mL/min/1.73m2
- Subject agrees to defer elective neurological surgery, including deep brain stimulation or lesional procedure for PD, invasive treatments, including levodopa or apomorphine infusion, or pump- pump-administered levodopa...
- Findings on baseline 18F-DOPA PET imaging consistent with dopaminergic denervation of the putamen
- Subject is willing and able to comply with all study visits and procedures in the opinion of the Investigator.
- people unable to give consent due to dementia or psychosis.
- Montreal Cognitive Assessment (MoCA) score \< 26
- people with a first-degree relative with Parkinson's disease or with a known genetic mutation predisposing to the development of Parkinson's disease (i.e.
- Atypical Parkinsonism (Parkinson's-Plus syndrome, secondary parkinsonism)
- Moderate or severe levodopa-induced dyskinesias in any body segment (such patients were found to be more prone to graft-induced dyskinesias in the fetal tissue studies that are proof of priniciple for this therapy)
- Neurologic history or imaging demonstrating brain pathology not directly related to Parkinson's disease that is likely to interfere with study compliance or assessment of Parkinson's related motor disability.
- History of stroke or transient ischemic attack
- History of subarachnoid hemorrhage
- Presence or history of psychosis within 12 months of screening
- Suicidal ideation associated with intent or plan in the past 12 months (an answer of "yes" to C-SSRS questions 4 or 5) or with a previous history of suicide attempts in the past 5 years.
- History of intracranial surgery including deep brain stimulation, focused ultrasound, stereotactic or radiosurgical lesion therapy
- History of malignancy within 5 years. Exceptions will be made for treated cutaneous squamous cell or basal cell carcinoma without evidence of metastasis.
- Use of anticoagulation / antiplatelet agents that cannot be stopped for one week in advance of and two days following surgery without significant risk to the subject
- Use of chronic immunosuppressive therapy including chronic steroids
- Contraindication to MRI or MRI contrast agents
- Pregnant or nursing women
- people with active cardiovascular and cerebrovascular disease within 6 months prior to signing the informed consent form.
- History of severe heart failure (congestive heart failure of New York Heart Association Class II or above or left ventricular ejection fraction \< 35% by any examination method), unstable angina pectoris and myocardial...
- Severe arrhythmia
- History of cardiovascular surgery (cardiac, vascular stent surgery, angioplasty)
- Patients with major vascular diseases (aortic aneurysm, aortic dissecting aneurysm, internal carotid artery stenosis)
- Hypertensive patients with poorly controlled blood pressure (defined as blood pressure consistently above 160/100 mmHg despite treatment with antihypertensive drugs) and patients with severe postural hypotension
- Diabetic patients with poorly controlled blood glucose (glycosylated hemoglobin \> 9.0%, or fasting plasma glucose (FPG) ≥ 11.1 mmol/L);
- people with alcohol or drug addiction
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, United States
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, but 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, 45 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.