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

NCT06587633 | Not Yet Recruiting

• 1 other identifier: 6913
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Efficacy of the custom-made 3D printed vascular stromal tissue and scaffolds to treat CGFs.

  Efficacy: endoscopic evaluation with or without radiological auxilium at 3 months after the procedure. Fistula will be described as: closed or still open. Further endoscopic evaluations with or without radiological auxilium could be repeated to assess maintenance of the closure.

  24 months

Secondary Outcomes (2)

• Evaluation of immunological response

  24 months

• Incidence of Treatment-Emergent Adverse Events

  24 months

Study Arms (1)

Endoscopic procedure

EXPERIMENTAL

Device: Endoscopic procedure

Interventions

Endoscopic procedure DEVICE

tSVFem injection + 3D scaffold placement

Endoscopic procedure

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead
• IRCCS Ospedale Casa Sollievo della Sofferenza: collaborator

Study Sites (1)

Fondazione Policlinico Universitario Agostino gemelli IRCCS

Roma, Italy

Location

MeSH Terms

Conditions

Fistula

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): June 10, 2026
• Study Completion (Estimated): September 10, 2026
• Last Updated: September 25, 2024

Record last verified: 2024-09

Locations

IT (1)