Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06598202
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
Exploring Nasal Drop Therapy With Small Extracellular Vesicles for ALS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Exploratory Study on the Use of Intranasal Administration of Small Extracellular Vesicles for the Treatment of Amyotrophic Lateral Sclerosis
Status:
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:
de-ALS
Brief Summary:
This is a multicenter randomized double-blind placebo-controlled dose-escalation trial The goal of this clinical trial is to evaluate the safety and preliminary efficacy of nasal drop exosomes derived from human umbilical cord blood mesenchymal stem cells hUC-MSC-sEV-001 in amyotrophic lateral sclerosis
Detailed Description:
This is a multicenter randomized double-blind placebo-controlled dose-escalation trial The study will consist of two parts Part 1 will be a dose-escalation study and Part 2 will be an expanded safety study based on the findings from Part 1
A traditional 33 dose-escalation design will be implemented in Part 1 Cohort 1 will receive 141010 particlesmL Cohort 2 will receive 701010 particlesmL and Cohort 3 will receive 1751011 particlesmL Cohort 1 and Cohort 2 will receive a dose of 1 mL per nostril while Cohort 3 will receive 2 mL per nostril administered once daily twice a week for a total of two weeks If no dose-limiting toxicities DLTs are observed for 2 weeks after the administration of the first nasal drop a new cohort will be enrolled at the next planned dose level If DLTs are observed in one participant in the cohort an additional three participants will be treated at the same dose level Dose escalation will be stopped if DLTs are observed in more than 33 of the participants
In Part 2 20 subjects will be randomized in a 11 ratio exosome n10 or exosome placebo n10 The dose level will be determined by the primary researcher based on the findings from Part 1
A traditional 33 dose-escalation design will be implemented in Part 1 Cohort 1 will receive 141010 particlesmL Cohort 2 will receive 701010 particlesmL and Cohort 3 will receive 1751011 particlesmL Cohort 1 and Cohort 2 will receive a dose of 1 mL per nostril while Cohort 3 will receive 2 mL per nostril administered once daily twice a week for a total of two weeks If no dose-limiting toxicities DLTs are observed for 2 weeks after the administration of the first nasal drop a new cohort will be enrolled at the next planned dose level If DLTs are observed in one participant in the cohort an additional three participants will be treated at the same dose level Dose escalation will be stopped if DLTs are observed in more than 33 of the participants
In Part 2 20 subjects will be randomized in a 11 ratio exosome n10 or exosome placebo n10 The dose level will be determined by the primary researcher based on the findings from 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