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Mesenchymal Stem Cell Therapy in Multiple System Atrophy

NCT02315027 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-08

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

Autologous Mesenchymal Stem Cells

single dose of 1 × 10(7) cells intrathecally

BIOLOGICAL

Autologous Mesenchymal Stem Cells

2 doses of 5 × 10(7) cells intrathecally each 1 month (±4 days) apart

BIOLOGICAL

Autologous Mesenchymal Stem Cells

2 doses of 1 × 10(8) cells intrathecally each 1 month apart

BIOLOGICAL

Autologous Mesenchymal Stem Cells

Ten doses of 5 x 10(7) (±20%) cells intrathecally six months (±1 month) apart

BIOLOGICAL

Autologous Mesenchymal Stem Cells

Ten doses of 2.5 x 10(7) (±20%) cells intrathecally six months (±1 month) apart

Sponsors & Collaborators

  • Food and Drug Administration (FDA)

    collaborator FED

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Wolfgang Singer, MD · Mayo Clinic

  • Phillip Low, MD · Mayo Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2027-03-31
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02315027 on ClinicalTrials.gov