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Cell Therapy
MSK-DA01 Cell Therapy for Parkinson's Disease
Phase 1
Waitlist Available
Research Sponsored by BlueRock Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Taking levodopa, but with complications of therapy such as wearing off and/or dyskinesia
Age 50-78 years old (Canada)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 1 year post-transplant and baseline to 2 years post-transplant
Awards & highlights
Study Summary
This trial will test whether it is safe to surgically inject nerve cells that make dopamine into the brains of Parkinson's disease patients.
Who is the study for?
This trial is for Parkinson's disease patients aged 50-78 in Canada or 60-78 in the US, who've been diagnosed between 3 to 20 years ago and are experiencing complications from levodopa therapy. Participants need a study partner and must be able to undergo MRI and PET scans. Exclusions include other neurodegenerative diseases, past brain surgeries or therapies, high risk conditions for immunosuppressive drugs, inability to stop certain medications, pregnancy/breastfeeding, contraindications to surgery/anesthesia, recent cancer except specific types.Check my eligibility
What is being tested?
The trial is testing the safety of MSK-DA01 Cell Therapy for advanced Parkinson's Disease by surgically injecting dopamine-producing nerve cells into the brain. It aims to assess tolerability and monitor side effects that may arise from this novel intervention.See study design
What are the potential side effects?
Potential side effects might include reactions related to surgery or anesthesia risks such as infection or bleeding at the injection site; immune response against implanted cells; changes in motor function due to cell placement; general surgical risks like blood clots.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am on levodopa and experiencing side effects like sudden loss of effect or involuntary movements.
Select...
I am between 50 and 78 years old.
Select...
I am between 60 and 78 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 1 year post-transplant and baseline to 2 years post-transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 1 year post-transplant and baseline to 2 years post-transplant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and Tolerability
Secondary outcome measures
Changes in Motor Function
Changes in Waking Hours in "Off" State
Continued Safety and Tolerability
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: MSK-DA01Experimental Treatment2 Interventions
Find a Location
Who is running the clinical trial?
BlueRock TherapeuticsLead Sponsor
2 Previous Clinical Trials
412 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterOTHER
1,933 Previous Clinical Trials
585,610 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on levodopa and experiencing side effects like sudden loss of effect or involuntary movements.You weigh more than 350 pounds or have a condition that makes it difficult to have a PET/MRI scan.I haven't had cancer, except for skin or cervical cancer that was treated, in the last 5 years.I have had brain stimulation, lesion, or gene therapy for Parkinson's.I cannot stop my blood thinning medications without serious risk.I cannot undergo surgery or be given general anesthesia due to health risks.I have a condition that makes it risky for me to take drugs that weaken my immune system.I am between 50 and 78 years old.I am between 60 and 78 years old.I have been diagnosed with a condition like epilepsy, MS, Alzheimer's, or another similar neurological disorder.I have had surgery or radiation therapy on my brain or spinal cord.I was diagnosed with Parkinson's Disease between 3 to 20 years ago.
Research Study Groups:
This trial has the following groups:- Group 1: MSK-DA01
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Parkinson's Disease Patient Testimony for trial: Trial Name: NCT04802733 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What kind of participants are best suited for this experiment?
"Candidates with an advanced stage of Parkinson's between the ages of 50 and 78 are eligible for acceptance into this clinical trial. A total of 12 applicants will be admitted to participate in this medical study."
Answered by AI
Are there any potential adverse effects associated with MSK-DA01 usage?
"As MSK-DA01 is currently in its Phase 1, with limited evidence regarding the medication's safety and efficacy, Power estimated a score of 1 for this drug."
Answered by AI
Is the age range for this experiment limited to participants over 40?
"This trial strictly adheres to the inclusion criteria; therefore, participants must be between 50 and 78 years of age."
Answered by AI
Is this investigation presently open to participants?
"Per the details on clinicaltrials.gov, no new participants are being sought for this particular medical trial. Initially posted on May 3rd 2021 and last updated in late May 2022, recruitment efforts have been discontinued; however, there are still 484 other trials actively searching for patients at present."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
California
How old are they?
18 - 65
What site did they apply to?
University of California Irvine
Weill Cornell Medical College
Toronto Western Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1
Why did patients apply to this trial?
I've tried Carbidopa Levadopa and just made me sick to my stomach. Stopped taking months ago and looking for possible alternatives.
PatientReceived 1 prior treatment
I have tried carbidopa levodopa as recommended by my neurologist and had experienced upset stomach with extended release. Not on the prescription any longer. Looking for alternatives.
PatientReceived 1 prior treatment
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