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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%)

Must not have

Participants with malignant neoplasms

History of electroconvulsive therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I am between 30 and 80 years old and have been diagnosed with MSA.

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I have been diagnosed with MSA and have specific test results supporting this.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with cancer.

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I have undergone electroconvulsive therapy.

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My condition shows symptoms similar to Parkinson's Disease.

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I do not have an active infection, especially near a spinal injection site.

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I have had brain surgery for Parkinson's disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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