Mesenchymal Stem Cell Therapy for Multiple System Atrophy

Recruiting in Palo Alto (17 mi)

Overseen byWolfgang Singer, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Trial Summary

What is the purpose of this trial?The purpose of this study is to determine whether mesenchymal stem cells (MSCs) can be safely delivered to the cerebrospinal fluid (CSF) of patients with multiple system atrophy (MSA). Funding Source - FDA OOPD.

Eligibility Criteria

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.

Inclusion Criteria

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

Participants with an anticipated survival of at least 3 years in the opinion of the investigator

Participants who are willing and able to give informed consent

+3 more

Exclusion Criteria

I am not on medications that affect my nervous system's automatic functions.

I have been diagnosed with cancer.

Women of childbearing potential who do not practice an acceptable method of birth control

+8 more

Participant Groups

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.

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)