Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2026-02-23 @ 1:09 AM
Study NCT ID:
NCT02315027
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-03
First Post:
2014-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mesenchymal Stem Cell Therapy in Multiple System Atrophy
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Intrathecal Autologous Mesenchymal Stem Cell Therapy in Multiple System Atrophy (MSA) - Effect of Dose and Natural History
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
The primary aim is to evaluate the safety and tolerability of intrathecal injection of autologous MSCs in a dose escalation study in patients with MSA. Safety secondary goals include to monitor changes in peripheral blood and in components of CSF, and monitor for any changes of nervous system structures using MRI. Efficacy secondary goals include evaluating potential efficacy by providing a number of studies and instruments that will detect changes in the course of the disease in terms of autonomic and neurologic symptoms and deficits.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01FD004789 | FDA | None | https://reporter.nih.gov/quic… | View |
| R01NS092625 | NIH | None | https://reporter.nih.gov/quic… | View |