Ignite Creation Date:
2024-05-06 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05836883
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-12
First Post:
2023-04-19
Brief Title:
Study of ExoFlo for the Treatment of Perianal Fistulas
Sponsor:
Direct Biologics LLC
Organization:
Direct Biologics LLC
Study Overview
Official Title:
A Phase IBIIA Study of ExoFlo an Ex Vivo Culture-expanded Adult Allogeneic Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicle Isolate Product for the Treatment of Perianal Fistulizing Crohns Disease
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
To evaluate the safety and feasibility of ExoFlo as a treatment for Perianal Fistulizing Crohns Disease
Detailed Description:
This is a phase IBIIA multicenter single-blind placebo-controlled dose-escalation design randomized controlled trial for the treatment of Perianal Fistulizing Crohns Disease
Subjects will be randomized 21 Investigational Medicinal Product IMP to normal saline NS in 3 cohorts of 12 subjects as follows
Cohort 1 Local injection of 15 mL of IMP or NS on Day 0 8 IMP 4 NS Cohort 2 Local injection of 30 mL of IMP or NS on Day 0 8 IMP 4 NS Cohort 3 Local injection of 30 mL of IMP or NS on Day 0 and Month 3 8 IMP 4 NS
Subjects will be randomized 21 Investigational Medicinal Product IMP to normal saline NS in 3 cohorts of 12 subjects as follows
Cohort 1 Local injection of 15 mL of IMP or NS on Day 0 8 IMP 4 NS Cohort 2 Local injection of 30 mL of IMP or NS on Day 0 8 IMP 4 NS Cohort 3 Local injection of 30 mL of IMP or NS on Day 0 and Month 3 8 IMP 4 NS
Study Oversight
Has Oversight DMC:
None
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?:
None