← Back to Search

Stem Cell Therapy

Stem Cell Therapy for Multiple System Atrophy

Phase 2
Recruiting
Led By Wolfgang Singer, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinical diagnosis of MSA, fulfilling consensus criteria for probable MSA
UMSARS I (omitting question 11) between 5 and 17, and able to walk unaided (i.e. able to walk at least 50 yards without the use of a cane or walker, and without other support such as holding on to an arm or touching walls).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial is assessing the effectiveness and safety of delivering adipose-derived autologous mesenchymal stem cells into the spinal fluid of patients with multiple system atrophy (MSA), a rare, progressive, and fatal neurological condition characterized by autonomic failure, parkinsonism, and/or ataxia.

Who is the study for?
Adults aged 30-70 with Multiple System Atrophy (MSA) who can walk unaided and have a life expectancy of at least 3 years. They must have normal cognition, not be pregnant or breastfeeding, agree to birth control if applicable, and haven't taken investigational drugs recently. Excluded are those with MRI contraindications, unstable medical conditions, certain medication use, or severe heart, liver or kidney diseases.Check my eligibility
What is being tested?
This trial tests whether injecting patients' own mesenchymal stem cells into their spinal fluid is safe and effective for treating MSA. It's a randomized study where some get the real treatment while others get a placebo without knowing which one they received.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site in the spine such as pain or infection; immune responses since stem cells are involved; and possible unknown risks due to the innovative nature of this therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with probable multiple system atrophy (MSA).
Select...
I can walk by myself for at least 50 yards and my UMSARS I score is between 5 and 17.
Select...
I can walk by myself for at least 50 yards and my UMSARS I score is between 5 and 17.
Select...
My cognitive function is normal, scoring 26 or higher on the MOCA test.
Select...
I am between 30 and 70 years old and can consent to treatment.
Select...
I have been diagnosed with probable multiple system atrophy (MSA).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in UMSARS total (= UMSARS I + UMSARS II) score
Secondary outcome measures
Change in COMPASS select score
Change in UMSARS I score
Change in UMSARS II score
+2 more

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Arm 2Active Control2 Interventions
25 million mesenchymal stem cells administered intrathecally every 6 months for 2 injections (placebo injections at 3 month and 9 month timepoints)
Group II: Arm 1Active Control1 Intervention
25 million mesenchymal stem cells administered intrathecally every 3 months for 4 injections
Group III: Arm 3Placebo Group1 Intervention
Placebo (lactated Ringer's) administered intrathecally every 3 months for 4 injections

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,212 Previous Clinical Trials
3,766,962 Total Patients Enrolled
5 Trials studying Multiple System Atrophy
1,534 Patients Enrolled for Multiple System Atrophy
Wolfgang Singer, MDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
80 Total Patients Enrolled
1 Trials studying Multiple System Atrophy
30 Patients Enrolled for Multiple System Atrophy

Media Library

Autologous Mesenchymal Stem Cells (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05167721 — Phase 2
Multiple System Atrophy Research Study Groups: Arm 2, Arm 3, Arm 1
Multiple System Atrophy Clinical Trial 2023: Autologous Mesenchymal Stem Cells Highlights & Side Effects. Trial Name: NCT05167721 — Phase 2
Autologous Mesenchymal Stem Cells (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05167721 — Phase 2

Frequently Asked Questions

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

How can I join this clinical trial?

"The requirements for participants of this study are that they have multiple system atrophy and are between 30 to 70 years old. In total, the trial can take up 76 individuals."

Answered by AI

How many people are allowed to be enrolled in this research project?

"Yes, this is an ongoing trial that was first posted on December 15th 2021. The most recent update occurred on January 18th 2022. So far, 1 site has enrolled 76 patients."

Answered by AI

Can new patients join this research project?

"Yes, the trial is recruiting. According to information on clinicaltrials.gov, the trial was posted on December 15th 2021 and updated January 18th 2022. They are looking for 76 participants from 1 site."

Answered by AI

What is the most recent decision by the FDA in regards to Arm 2?

"While Phase 2 trials lack the efficacy data of a Phase 3, our team still believes that Arm 2 is safe."

Answered by AI

Does this experiment have an age limit? If so, what is it?

"To qualify for this study, patients must be between the ages of 30 and 70. In contrast, there are 43 other clinical trials that treat patients under 18 and 148 that target a demographic of seniors over 65."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
What site did they apply to?
Mayo Clinic
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I want to get better. Clinical Trials are the only way to help with this disease.
PatientReceived 1 prior treatment
I am seeking help with my condition. I also would like to help people in the future. I know what I have is rare, so I am exploring all my options.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Randomized Double-Blind Placebo-Controlled Adaptive Design Trial Of Intrathecally Administered Autologous Mesenchymal Stem Cells In Multiple System Atrophy
Wolfgang Singer, MD 2021. "Randomized Double-Blind Placebo-Controlled Adaptive Design Trial Of Intrathecally Administered Autologous Mesenchymal Stem Cells In Multiple System Atrophy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05167721.
All > Multiple System Atrophy
~31 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top