Ignite Creation Date:
2024-05-06 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 12:41 PM
Study NCT ID:
NCT03449069
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2018-02-22
Brief Title:
Pediatric MSC-AFP Sub-study for Crohns Fistula
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Phase I Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With Fistulizing Crohns Disease Pediatric Sub-study
Status:
COMPLETED
Status Verified Date:
2024-03
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 the safety of using an autologous mesenchymal stromal cell MSC coated fistula plug in people with fistulizing Crohns disease Autologous means these cells to coat the plug come from the patient
Detailed Description:
The investigators propose to study the safety of autologous mesenchymal stromal cell transfer using a biomatrix the Gore Bio-A Fistula Plug in a Phase I study using a single dose of 20 million cells 5 patients age 12 to 17 years with Crohns perianal fistulas will be enrolled
Subjects will undergo standard adjuvant therapy including drainage of infection and placement of a draining seton Six weeks post placement of the draining seton the seton will be replaced with the MSC loaded Gore fistula plug as per current clinical practice The subjects will be subsequently followed for fistula response and closure for 24 months This is an autologous product derived from the patient and used only for the same patient
Subjects will undergo standard adjuvant therapy including drainage of infection and placement of a draining seton Six weeks post placement of the draining seton the seton will be replaced with the MSC loaded Gore fistula plug as per current clinical practice The subjects will be subsequently followed for fistula response and closure for 24 months This is an autologous product derived from the patient and used only for the same patient
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