Ignite Creation Date:
2024-05-06 @ 1:51 AM
Last Modification Date:
2024-10-26 @ 11:10 AM
Study NCT ID:
NCT01915927
Status:
COMPLETED
Last Update Posted:
2020-01-03
First Post:
2013-07-31
Brief Title:
Stem Cell Fistula Plug in Perianal Crohns Disease
Sponsor:
William A Faubion MD
Organization:
Mayo Clinic
Study Overview
Official Title:
A Phase 1 Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With Fistulizing Crohns Disease
Status:
COMPLETED
Status Verified Date:
2019-12
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:
MSC-AFP
Brief Summary:
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 Twenty adult patients age 18 years or older with refractory complicated perianal fistulizing Crohns disease will be enrolled Subjects will undergo standard adjuvant therapy including drainage of infection and placement of a draining seton with continuation of pre-existing anti-Crohns therapy Six weeks post placement of the draining seton the seton will be replaced with the MSC loaded Gore Bio-A 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
Detailed Description:
None
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