Is NCT06687837 recruiting in Boston, MA?

Yes, NCT06687837 is currently recruiting participants at its Boston, MA location. This parkinson disease clinical trial is actively enrolling qualified participants.

How do I join the parkinson disease clinical trial in Boston?

To join this clinical trial in Boston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Boston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Parkinson Disease Clinical Trial in Boston, MA

About This Parkinson Disease Study in Boston

The goal of this clinical trial is to assess the safety and tolerability of the surgical transplantation of dopaminergic progenitor cells into the brains of participants with Parkinson's disease. The transplanted dopaminergic cells will be derived from the participant's own skin cells.

Sponsor: Jeffrey S. Schweitzer, MD, PhD

Who Can Participate

Inclusion 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.

Acceptable surgical laboratory values including:

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 intestinal gel, until after the study's primary outcome is completed.

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.

Exclusion Criteria

Subjects unable to give consent due to dementia or psychosis.

Montreal Cognitive Assessment (MoCA) score \< 26

Subjects 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. this initial study is confined to the more common "sporadic" vs a "genetic" form of the 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 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

Subjects 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 infarction/

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);

Subjects with alcohol or drug addiction

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Boston?

Yes, this clinical trial (NCT06687837) has an active research site in Boston, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Parkinson Disease Treatment Options in Boston, MA

If you're searching for parkinson disease treatment options in Boston, MA, this clinical trial (NCT06687837) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Boston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced parkinson disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all parkinson disease clinical trials near you to find additional studies recruiting in your area.

Parkinson Disease Clinical Trial in Boston, MA

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