Fistula3DReGNCT06587633
3D BIO-STRUCTURES FOR G.I. POST-SURGICAL DEFECTS
A study testing Endoscopic procedure in people with Fistula, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Fistula
- What is being tested?
- Endoscopic procedure
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2024to 10 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- patients who have not given informed consent to the procedure;
- patients with entero-enteral CGF,
- patients who have therapeutic options of other type.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario Agostino gemelli IRCCS
Roma
Massimiliano Papi, +39 06 3015 4566, massimiliano.papi@unicatt.it
About this study
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
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
- Being tested
- Endoscopic procedure
- Medical subject headings
- Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic procedureDevice
tSVFem injection + 3D scaffold placement
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic procedure | Experimental | Not described Receives: Device: Endoscopic procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (2)
Evaluation of immunological response
Exposure of the tSVFem-containing scaffolds to peripheral blood mononuclear cells obtained from the same patient. Microbiota analysis (obtained from stool sample of the patient) before and after the treatment. DNA extraction, metagenomics or 16S rRNA gene sequencing will be used to determine the diversity and abundance of the microbial community. Statistical analysis will be performed to identify specific microbial taxa that have changed significantly. PICRUSt2 and ALDEx2 tools will be applied to identify microbial signatures
Measured: 24 months
Incidence of Treatment-Emergent Adverse Events
treatment-related adverse events as assessed by CTCAE v5.0 will be registered during follow-up
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion10 Jun 2026 (estimated)
- Study completion10 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FistulaStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS Casa Sollievo della Sofferenza
- Responsible party
- Principal investigator, Papi Massimiliano, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587633
- Sponsor's protocol ID
- 6913
- Acronym
- 3DReG
- Status last verified
- Sep 2024
- First submitted
- 28 Aug 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06587633
- Acronym / sponsor ID
- 3DReG / 6913
- Conditions
- Fistula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Collaborators
- IRCCS Casa Sollievo della Sofferenza
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 10 Jun 2026 (estimated)
- Study completion
- 10 Sep 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic procedure | Experimental | Device: Endoscopic procedure |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- patients who have not given informed consent to the procedure;
- patients with entero-enteral CGF,
- patients who have therapeutic options of other type.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic proceduretSVFem injection + 3D scaffold placement | Device | Endoscopic procedure |
Primary outcome
Efficacy of the custom-made 3D printed vascular stromal tissue and scaffolds to treat CGFs.
Time frame: 24 months
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.
2 secondary outcomes
Evaluation of immunological response
Time frame: 24 months
Incidence of Treatment-Emergent Adverse Events
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fondazione Policlinico Universitario Agostino gemelli IRCCS
Roma, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic procedure in people with Fistula, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of the custom-made 3D printed vascular stromal tissue and scaffolds to treat CGFs. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.