MSK-DA01 Cell Delivery Device for Parkinson Disease

Phase-Based Estimates
1
Effectiveness
1
Safety
Toronto Western Hospital, Toronto, Canada
Parkinson Disease+1 More
MSK-DA01 Cell Delivery Device - Device
Eligibility
18+
All Sexes
Eligible conditions
Parkinson Disease

Study Summary

This study is evaluating whether surgically injecting nerve cells that make dopamine into the brain of Parkinson's disease patients is safe, and to monitor for potential side effects.

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Eligible Conditions

  • Parkinson Disease
  • Advanced Parkinson's Disease

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether MSK-DA01 Cell Delivery Device will improve 1 primary outcome and 4 secondary outcomes in patients with Parkinson Disease. Measurement will happen over the course of Baseline to 1 Year Post-Transplant.

Year 1
Safety and Tolerability
Year 2
Changes in Motor Function
Changes in Waking Hours in "Off" State
Continued Safety and Tolerability
Evidence of Cell Survival

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

Control
MSK-DA01

This trial requires 12 total participants across 2 different treatment groups

This trial involves 2 different treatments. MSK-DA01 Cell Delivery Device is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

MSK-DA01
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 1 year post-transplant and baseline to 2 years post-transplant
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline to 1 year post-transplant and baseline to 2 years post-transplant for reporting.

Closest Location

Toronto Western Hospital - Toronto, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age 60-78 years old (United States)
You are taking levodopa, but with complications of therapy such as wearing off and/or dyskinesia. show original
Existence of a study partner who may act as potential surrogate over long term for ongoing consent
If you are in the age range of 50-78 years old, you are eligible for the study. show original
You have been diagnosed with Parkinson's disease between 3 and 20 years ago. show original
You are able to participate in all study visits and evaluations, including brain MRI and PET scan. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for parkinson disease?

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Parkinson disease is commonly treated with the use of medications such as levodopa and carbidopa/levodopa. Deep brain stimulation and bilateral subthalamic nucleus implant and deep brain stimulation combined with subthalamic nucleus implant, deep brain stimulation combined with lesioning is a commonly practiced treatment for severe motor deficits. Botulinum toxin injection, stereotactic radiosurgery, and deep brain stimulation combined with bilateral subthalamic nucleus implant seems to be effective for refractory tremors. Deep brain stimulation combined with subthalamic nucleus implant is considered the most likely treatment for severe motor dysfunction in parkinson disease.

Unverified Answer

Can parkinson disease be cured?

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We could not find any statistical significance between treatments of Parkinson's patients and non-Parkinson patients, nor in any of the treatments tested with regard to the primary outcome (motor evolution in the ON-ON patients). The study also demonstrated that it is possible to perform prospective studies in Parkinson's, which must be considered as an option for researchers in this field. The fact that some drugs, such as the MAO inhibitors, do not seem to have an effect on the course of Parkinson's makes us question if they can cure Parkinson's at all.

Unverified Answer

What causes parkinson disease?

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There are probably multifactorial causes of PD, including environmental and genetic factors. A plausible hypothesis is disruption or loss of dopaminergic neurons in the nigrostriatal pathway by abnormal microglial cell function. It has also been proposed that neuroinflammation is an important factor in the disease process and may play a role in PD etiology by increasing oxidative stress and stimulating neuroinflammatory processes.

Unverified Answer

What are the signs of parkinson disease?

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The signs of Parkinson disease are typically nonspecific and include: tremor, slowness of movement, stiffness, and a failure to stand up from a chair. The onset of Parkinson disease can be delayed by many years. The disease is usually progressive but can sometimes improve significantly. As the disease progresses, the symptoms worsen and the patient deteriorates.\n\nThere are many types of epilepsy, and some of the most common symptoms are a feeling of an electric shock, shaking, or falling ill when a seizure breaks out and the person feels overwhelmed. If a seizure lasts a while, a person may forget the incident. There may be brief bouts of confusion in addition to other symptoms and it may result in the person hitting other people.

Unverified Answer

What is parkinson disease?

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Motor symptoms of PD include progressive stiffness and muscle contracture. The tremors of PD are typically rhythmic and may appear to increase over time. The tremor tends to appear as the disease worsens. The main symptom is the inability to control the voluntary movement of the extremities. The head may also be affected before the onset of limb dyskinesia. The progression of PD is variable with different individuals, with some being able to live 20-30 years with the disease. Once diagnosed patients should have regular screening and a careful review every 2–3 years. It is important if symptoms develop to suspect the disease as early as possible. Once the diagnosis is made, further tests are not always required.

Unverified Answer

How many people get parkinson disease a year in the United States?

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[Parkinson's disease is the most commonly occurring neurodegenerative movement disorder that can manifest during the elderly years.] More than 90% of reported PD occurs between ages 45 and 64; however, the [prevalence of PD among the elderly is growing more rapidly than in previous decades. Current estimates of the [number of PD cases reported to the US National Parkinson's Disease Association are comparable to previously published estimates (in terms of [prevalence])] (Parkinson's Disease Association, 2016).

Unverified Answer

Have there been any new discoveries for treating parkinson disease?

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All Parkinson's disease drug therapies show dramatic improvements in motor function but they have very limited impact on treating motor symptoms, including dyskinesias. It is not clear why PD patients do not respond to existing drugs that are usually very effective. In addition, most researchers are still working only on the 'core' symptoms of PD, such as tremor and gait disturbances. However, new therapeutic possibilities have recently begun to be discussed for specific symptoms as described below.\n\nPatients with Parkinson’s disease exhibit changes including, tremors, gait disturbance, abnormal postural control. \n\nIn the early stage of the disease tremors are the most common motor symptom.

Unverified Answer

What are the common side effects of msk-da01 cell delivery device?

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The clinical trial results for the human mesenchymal stem cells demonstrated that many symptoms of msk-da01 device were transient and did not lead to permanent loss of body function, which could be a promising therapy for PD.

Unverified Answer

Is msk-da01 cell delivery device safe for people?

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In this pilot study, the majority of patients (78%) were satisfied or very satisfied with the implant. The most common side effects were local and general symptoms. No patients were found to experience a device related complication requiring removal.

Unverified Answer

What is the average age someone gets parkinson disease?

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[The majority of people with PD have an initial onset in their early 70s which is consistent with current models of PD pathogenesis and age-specific clinical onset of PD(http://www.parkinson.org/parkinson-help-and-support/symptoms of parkinson's disease)]. [See Power] is there an underrepresented Parkinson clinical trials in a younger population?\n

Unverified Answer

What is the primary cause of parkinson disease?

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It is essential to make some of the specific clinical observations of the PD clinical case to try to gain a fuller understanding of the disease. There are so many potential causes for PD, and many of them are potentially reversible with proper timing and proper and effective treatment.

Unverified Answer

How serious can parkinson disease be?

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Significant functional and physical disability occur early in the course of the disease. However, no single symptom predicts a poor outcome. Even if PD is asymptomatic at initial presentation, it is progressive. As such, patients with severe PD may be at a higher risk of having to withdraw from treatment because of functional/motor deterioration.

Unverified Answer
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