3D BIO-STRUCTURES FOR G.I. POST-SURGICAL DEFECTS

NCT ID: NCT06587633

Last Updated: 2024-09-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2026-09-10

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 patient's cells. This approach aims to promote tissue regeneration and integration, repair extensive CGF and restore the proper microbiota.

A small portion of the patient's 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.

Conditions

Fistula

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endoscopic procedure

Group Type: EXPERIMENTAL

Endoscopic procedure

Intervention Type: DEVICE

tSVFem injection + 3D scaffold placement

Interventions

Endoscopic procedure

tSVFem injection + 3D scaffold placement

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• patients with CGF at any level that can be approached endoscopically and for whom the possibility of conventional conservative treatment is ruled out, or all possible conservative or surgical treatments have already been performed without benefit, or in whom the reiteration of such treatments is contraindicated, because of life-threatening, and/or possible complications, and/or disabling outcomes.

Exclusion Criteria

• patients who have not given informed consent to the procedure;
• patients with entero-enteral CGF,
• patients who have therapeutic options of other type.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Ospedale Casa Sollievo della Sofferenza

UNKNOWN

Sponsor Role: collaborator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Papi Massimiliano

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fondazione Policlinico Universitario Agostino gemelli IRCCS

Roma, , Italy

Countries

Italy

Facility Contacts

Massimiliano Papi

Role: primary

massimiliano.papi@unicatt.it

+39 06 3015 4566

Other Identifiers

6913

Identifier Type: -

Identifier Source: org_study_id