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Stem Cell Therapy
MSC for Parkinson's Disease
Phase 2
Waitlist Available
Led By Mya C Schiess, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline,week 7,week 20,week 29,week 39,week 52,week 78
Awards & highlights
Study Summary
This trial will test how safe and effective it is to give multiple doses of stem cells to people with Parkinson's disease.
Eligible Conditions
- Parkinson's Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline,week 7,week 20,week 29,week 39,week 52,week 78
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline,week 7,week 20,week 29,week 39,week 52,week 78
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Parkinson Disease
Secondary outcome measures
Behavioral changes as measured by the Columbia Suicide Severity Rating Scale (C-SSRS)
Behavioral changes as measured by the Geriatric Depression Scale-Short Form (GDS-SF)
Behavioral changes as measured by the Parkinson Anxiety Scale (PAS)
+16 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: MSC+placeboExperimental Treatment1 Intervention
2 treatment doses + 1 placebo 3 months apart
Group II: MSCExperimental Treatment1 Intervention
3 treatment doses 3 months apart
Group III: PlaceboPlacebo Group1 Intervention
3 placebo doses 3 months apart
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MSC+placebo
2020
Completed Phase 2
~50
MSC
2017
Completed Phase 2
~410
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
903 Previous Clinical Trials
320,932 Total Patients Enrolled
Michael J. Fox Foundation for Parkinson's ResearchOTHER
112 Previous Clinical Trials
535,111 Total Patients Enrolled
Mya C Schiess, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
2 Previous Clinical Trials
314 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a mild to complete loss of sense of smell.You have mild to moderate Parkinson's disease.You have been diagnosed with Parkinson's disease between 3 and 10 years ago.You have a score lower than 25 on a test that measures thinking and memory skills.You have seizures that are not under control.You have severe and unresponsive low blood pressure when standing up.You have a lung condition called COPD where you need oxygen even when resting or moving around, or you have moderate to severe asthma.You are currently thinking about harming yourself or have engaged in self-harming behaviors.You have a condition that weakens your immune system or an autoimmune disease.You have had a stroke involving bigger blood vessels in your brain.You have had a head injury in the past that caused loss of consciousness and ongoing neurological symptoms.You have a problem with using drugs or alcohol.You have a mild to complete loss of your sense of smell.You have shown a strong positive response to treatment with drugs that affect dopamine in the brain.You have a type of Parkinson's disease that is not the typical kind, or is caused by certain medications or blood vessel problems.You have severe mental health symptoms like hallucinations that are hard to treat.You have a history of heart failure or heart rhythm problems.You have had brain surgery in the past for Parkinson's disease.Your Parkinson's disease is not advanced (stage 3 or less according to a specific scale).
Research Study Groups:
This trial has the following groups:- Group 1: MSC
- Group 2: Placebo
- Group 3: MSC+placebo
Awards:
This trial has 0 awards, including: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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are patients who are over 35 years old able to participate in this trial?
"According to the inclusion criteria, this clinical trial is only available for patients aged 50-79. In contrast, there are 28 trials for children and 514 trials for adults over 65."
Answered by AI
Are there any slots left for patients who want to enroll in this clinical trial?
"According to the listing on clinicaltrials.gov, this study is not recruiting patients at this time. The original posting was on November 9th 2020 and there have been no edits since January 26th 2022. However, 517 other studies are actively looking for participants."
Answered by AI
Are there any dangers that patients should be made aware of before using MSC?
"Given that this is a Phase 2 trial - meaning while there is some safety data, there is none yet for efficacy - our team has given MSC a score of 2."
Answered by AI
Are people with pre-existing medical conditions able to join this trial?
"The ideal candidate for this study should have a diagnosis of PD, be between the ages of 50-79, and 45 people are needed in total."
Answered by AI
Who else is applying?
What state do they live in?
Ontario
Texas
How old are they?
18 - 65
What site did they apply to?
The University of Texas Health Science Center at Houston
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
How responsive is this trial?
Typically responds via
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