Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06587633
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-28
Brief Title:
3D BIO-STRUCTURES FOR GI POST-SURGICAL DEFECTS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
3D BIO-STRUCTURES POPULATED WITH MICRO-FRAGMENTED EMULSIFIED STROMAL TISSUE DERIVED FROM AUTOLOGOUS ADIPOSE TISSUE HARVESTING FOR THE REGENERATIVE TREATMENT OF POST-SURGICAL DEFECTS OF THE GASTROINTESTINAL TRACT
Status:
NOT_YET_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:
3DReG
Brief Summary:
The study is focused on evaluating the safety and efficacy of using vascular stromal tissue derived from autologous adipose tissue and subjected to microfragmentation and emulsification Stromal Vascular Fraction Micro-Emulsion - tSVFem in the treatment of chronic gastrointestinal fistulae CGF Tissue regeneration will be stimulated using 3D bio-printed scaffolds enriched at implantation with mesenchymal stem cells derived from patients adipose tissue injection of tSVFem and scaffold placement will be performed endoscopically The study proposes to use 3D bioprinting to create customized polymeric bioinks gels on supporting scaffolds that can serve as a framework for the growth and development of the patients cells This approach aims to promote tissue regeneration and integration repair extensive CGF and restore the proper microbiota
A small portion of the patients tSVFem will be injected in a bioreactor into the scaffolds and used for evaluation of the ability of the scaffolds to support cell proliferation migration and differentiation as well as secretion of cytokines and growth factors and the immunological response Also to analyze the effect on cells and microbial species the intestinal microbiota will be analyzed in a bioreactor under different dynamic conditions on the growth and differentiation of the MSCs contained in tsVFem on the bio-printed scaffolds and the immunological results
A small portion of the patients tSVFem will be injected in a bioreactor into the scaffolds and used for evaluation of the ability of the scaffolds to support cell proliferation migration and differentiation as well as secretion of cytokines and growth factors and the immunological response Also to analyze the effect on cells and microbial species the intestinal microbiota will be analyzed in a bioreactor under different dynamic conditions on the growth and differentiation of the MSCs contained in tsVFem on the bio-printed scaffolds and the immunological results
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