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Stem Cell Therapy
Mesenchymal Stem Cell Therapy for Multiple System Atrophy
Phase 1 & 2
Waitlist Available
Led By Phillip Low, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants aged 30-80 years old with a diagnosis of MSA based on clinical criteria and standardized autonomic testing
Patients fulfilling Gilman Criteria (2000) for probable MSA of the parkinsonian subtype (MSA-P) or cerebellar subtype (MSA-C) and have findings on autonomic function testing suggestive of MSA (CASS ≥5 or a TST% ≥25%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 months
Awards & highlights
Study Summary
This trial will test whether it is safe to deliver mesenchymal stem cells to the cerebrospinal fluid of patients with multiple system atrophy.
Who is the study for?
This trial is for people aged 30-80 with multiple system atrophy (MSA), who meet specific clinical criteria and have a certain level of autonomic dysfunction. They should expect to live at least 3 more years, be able to consent, have normal cognition, and be within 4 years of MSA diagnosis. It excludes pregnant women not using birth control, those with unstable conditions or cancer, recent investigational drug use, medications affecting autonomic function, Parkinson-like diseases, dementia, brain surgery history for Parkinson's disease or contraindications for MRI.Check my eligibility
What is being tested?
The study tests if mesenchymal stem cells can be safely given into the cerebrospinal fluid of patients with multiple system atrophy. The goal is to see if this treatment is safe and how it affects the disease.See study design
What are the potential side effects?
Potential side effects may include reactions related to stem cell infusion such as pain or infection at the injection site; immune responses like fever; headache; back pain; nausea; potential risks associated with spinal procedures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 30 and 80 years old and have been diagnosed with MSA.
Select...
I have been diagnosed with MSA and have specific test results supporting this.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse event frequency (by severity, type, attribution, and intervention dose).
Secondary outcome measures
Change in CASS score and thermoregulatory sweat test (TST) % from baseline to 12 months.
Change in CSF biomarkers from baseline to 2 months.
MRI morphometric changes using dedicated algorithms to evaluate rate of atrophy of defined areas of brain from baseline to 12 months.
+4 moreTrial Design
5Treatment groups
Experimental Treatment
Group I: 2 doses of 5 × 10(7) MSCsExperimental Treatment1 Intervention
Group 2: Participants will receive one intrathecal dose of 5 × 10(7) mesenchymal stem cells (MSCs), followed by a second intrathecal dose of 5 × 10(7) MSCs approximately one month later
Group II: 2 doses of 1 × 10(8) MSCsExperimental Treatment1 Intervention
Group 3: Participants will receive one intrathecal dose of 1 × 10(8) mesenchymal stem cells (MSCs), followed by a second intrathecal dose of 1 × 10(8) MSCs approximately one month later
Group III: 10 doses of 5 x 10(7) (±20%) MSCsExperimental Treatment1 Intervention
Group 4: Participants will receive up to 10 doses of 5 x 10(7) (±20%) mesenchymal stem cells (MSCs) approximately 6 months apart.
Group IV: 10 doses of 2.5 x 10(7) (±20%) MSCsExperimental Treatment1 Intervention
Group 5: Participants will receive up to 10 doses of 2.5 x 10(7) (±20%) mesenchymal stem cells (MSCs) approximately 6 months apart.
Group V: 1 dose of 1 × 10(7) MSCsExperimental Treatment1 Intervention
Group 1: Participants will receive a single intrathecal dose of 1 × 10(7) mesenchymal stem cells (MSCs)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Autologous Mesenchymal Stem Cells
2012
Completed Phase 2
~40
Find a Location
Who is running the clinical trial?
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,339 Previous Clinical Trials
649,276 Total Patients Enrolled
10 Trials studying Multiple System Atrophy
2,039 Patients Enrolled for Multiple System Atrophy
Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,767,053 Total Patients Enrolled
5 Trials studying Multiple System Atrophy
1,580 Patients Enrolled for Multiple System Atrophy
Food and Drug Administration (FDA)FED
171 Previous Clinical Trials
1,331,576 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 30 and 80 years old and have been diagnosed with MSA.I am not on medications that affect my nervous system's automatic functions.I have been diagnosed with cancer.You have good memory and thinking skills, as tested by the Mini-Mental State Examination, with a score higher than 24.You have been diagnosed with dementia and your score on the Mini-Mental State Examination is less than 24.I do not have any health conditions that would make it unsafe for me to participate in the study.My condition shows symptoms similar to Parkinson's Disease.You cannot have an MRI scan for medical reasons.I do not have an active infection, especially near a spinal injection site.I have undergone electroconvulsive therapy.I have been diagnosed with MSA and have specific test results supporting this.I have had brain surgery for Parkinson's disease.My MSA diagnosis was less than 4 years ago.
Research Study Groups:
This trial has the following groups:- Group 1: 10 doses of 2.5 x 10(7) (±20%) MSCs
- Group 2: 2 doses of 5 × 10(7) MSCs
- Group 3: 2 doses of 1 × 10(8) MSCs
- Group 4: 10 doses of 5 x 10(7) (±20%) MSCs
- Group 5: 1 dose of 1 × 10(7) MSCs
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How can I sign up for this opportunity to help test a new treatment?
"This trial is looking for 30 patients that have experienced atrophy and are between the ages of 30 and 80. The most crucial aspect is that candidates meet the following criteria: • Participants aged 30-80 years old with a diagnosis of MSA based on clinical criteria and standardized autonomic testing. This approach allows for identification of patients with MSA with very high specificity and is yet sensitive enough to allow for enrollment of patients at a disease stage at which an intervention on the natural disease course has a meaningful impact on patient outcome. Patients therefore have to fulfill Gilman Criteria (2000) for probable MSA of the parkinsonian sub"
Answered by AI
Are new participants being enrolled in this trial at this time?
"From what is visible on clinicaltrials.gov, this particular trial has already closed recruitment. The study was created on October 1st 2012 and edited for the last time September 8th 2022. Although this specific trial is not looking for patients, there are currently 195 other trials that are still recruiting individuals."
Answered by AI
Does this research involve geriatric patients?
"According to the restrictions set by the study, individuals must be between 30 and 80 years old in order to participate."
Answered by AI
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