Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06620809
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-22
Brief Title:
The Safety and Efficacy of NouvSoma001 in Neuromyelitis Optica Spectrum Disorders
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-Label Exploratory Clinical Trial to Assess the Safety and Efficacy of NouvSoma001 in the Treatment of Neuromyelitis Optica Spectrum Disorders
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-center randomized open-label placebo-controlled dose-escalation trial The objective of this research is to evaluate the safety tolerability and efficacy of intrathecal administration of human-induced neural stem cell-derived extracellular vesicles NouvSoma001 for the treatment of neuromyelitis optica spectrum disorders
Detailed Description:
This is a single-center randomized open-label placebo-controlled dose-escalation trial The study consists of two parts Part 1 is a dose-escalation study while Part 2 is a dose-extension study based on the results of Part 1 Part 1 will follow a traditional 33 dose-escalation design enrolling a total of 9 subjects In Cohort 1 participants will receive 5 109 particles in Cohort 2 they will receive 15 1010 particles and in Cohort 3 they will receive 3 1010 particles If no dose-limiting toxicities DLTs are observed within 2 weeks after the initial administration a new cohort will be enrolled at the next higher dose level If DLTs are observed in 1 participant another 2 participants will be treated at the same dose level Dose escalation will cease if DLTs are observed in more than 33 of the participants In Part 2 the remaining 60 participants will be randomized in a 21 ratio to the treatment and placebo groups with the dose level determined by the Data Safety Monitoring Board based on the results of Part 1
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None