Ignite Creation Date:
2024-05-06 @ 9:35 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03014219
Status:
WITHDRAWN
Last Update Posted:
2017-07-06
First Post:
2017-01-04
Brief Title:
Phase 1 Crohns Pediatric Sub-study of MSC AFP
Sponsor:
William A Faubion MD
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:
WITHDRAWN
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
FDA approval was not obtained until adult trial completes accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 20 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
Detailed Description:
Visit 1 Patients will be evaluated for eligibility inclusionexclusion checklist and written informed consent will be obtained Patients will undergo general exam with vital signs Patients will be scheduled for a fat biopsy to collect the tissue needed to grow MSC In the event there is no cell growth from the tissue obtained from the first biopsy one further attempt will made from a second tissue sample from this patient However if the second attempt fails to grow cells no further attempts will be made and the subject will not continue in the study
The subjects will be subsequently followed for fistula response and closure for 24 months Study visits are Day 1 Week 2 Week 4 Week 8 Week 12 Week 24 Week 52 and Week 104 This is an autologous product derived from the patient and used only for the same patient
The subjects will be subsequently followed for fistula response and closure for 24 months Study visits are Day 1 Week 2 Week 4 Week 8 Week 12 Week 24 Week 52 and Week 104 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