An interventional study of Endoscopic tSVF-EM Therapy in Fistula, Regenerative Medicine and Stromal Vascular Fraction, sponsored by Asian Institute of Gastroenterology, India. Not yet recruiting at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by Asian Institute of Gastroenterology, India · Not applicable, Interventional, and Other
RESTOREGI Study Benign gastrointestinal fistulas are abnormal communications between the gastrointestinal tract and adjacent organs or the skin. Chronic fistulas are often difficult to treat because of persistent inflammation, fibrosis, impaired vascularity, and defective tissue regeneration. Endoscopic regenerative therapy using mechanically processed autologous total stromal vascular fraction-enriched microfragmented adipose tissue (tSVF-EM) has emerged as a novel therapeutic approach that may promote tissue repair through angiogenesis, immunomodulation, and regenerative signaling.
Although early clinical experience suggests promising healing outcomes, factors predicting successful fistula closure remain poorly understood. The RESTOREGI study is a prospective, single-center observational cohort study designed to identify patient-related, fistula-related, and procedural factors associated with successful healing following endoscopic tSVF-EM therapy in benign gastrointestinal fistulas. The study will also evaluate treatment safety, time to healing, recurrence rates, and the impact of procedural variables on outcomes.
Benign gastrointestinal fistulas are abnormal communications between the gastrointestinal tract and adjacent organs or the skin that can result in significant morbidity, prolonged hospitalization, impaired quality of life, and repeated therapeutic interventions. Chronic fistulas are characterized by persistent inflammation, fibrosis, impaired perfusion, and defective tissue regeneration, all of which may contribute to failure of conventional closure techniques and recurrent disease.
Endoscopic regenerative therapy using autologous total stromal vascular fraction-enriched microfragmented adipose tissue (tSVF-EM) has emerged as a novel therapeutic approach for the management of complex gastrointestinal defects. Following adipose tissue harvest and mechanical processing, tSVF-EM contains a heterogeneous population of stromal and regenerative cells, extracellular matrix components, and bioactive factors that may promote angiogenesis, immunomodulation, tissue remodeling, and wound healing. Endoscopic delivery of this material directly into the fistula margins aims to create a biologically favorable environment for durable tissue repair.
Early clinical experience with regenerative endoscopic therapies has demonstrated technical feasibility and encouraging healing outcomes in selected patients with benign gastrointestinal fistulas. However, considerable variability in treatment response exists, and factors associated with successful healing remain poorly understood. Improved understanding of patient-related, fistula-related, and procedural determinants of treatment success may facilitate better patient selection, optimize procedural planning, guide the use of adjunctive therapies, and improve overall clinical outcomes.
The RESTOREGI study is a prospective, single-center, real-world cohort study designed to evaluate clinical outcomes following endoscopic tSVF-EM therapy in patients with benign gastrointestinal fistulas. Standardised data will be collected regarding patient characteristics, fistula anatomy and etiology, inflammatory and nutritional status, and procedural factors associated with regenerative endotherapy. The study is intended as an exploratory, hypothesis-generating investigation to identify clinically meaningful factors associated with fistula healing and to establish prospective safety and effectiveness data in this emerging field of regenerative endoscopy.
Findings from this study are expected to provide foundational evidence for future multicenter studies and contribute to the development of evidence-based patient selection and treatment strategies for regenerative management of benign gastrointestinal fistulas.
219 studies on the registry are indexed under Fistula; 49 are open to participants now.
This study's planned enrollment of 50 is close to the median of 50 across 152 interventional studies indexed under Fistula.
Browse Fistula studies →Asian Institute of Gastroenterology, India is the lead sponsor of 135 studies on the registry; 59 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with benign gastrointestinal fistulas will undergo endoscopic regenerative therapy using autologous total stromal vascular fraction-enriched microfragmented adipose tissue (tSVF-EM). Adjunctive endoscopic therapies including argon plasma coagulation, tract abrasion, clipping, over-the-scope clip placement, endoscopic suturing, or stenting may be performed at the discretion of the treating physician. Repeat tSVF-EM sessions are permitted according to clinical response.
Procedure: Endoscopic tSVF-EM Therapy
Autologous adipose tissue will be harvested using standard liposuction techniques and mechanically processed to obtain total stromal vascular fraction-enriched microfragmented adipose tissue (tSVF-EM). The processed tissue will be injected endoscopically into the margins and/or tract of benign gastrointestinal fistulas according to institutional regenerative endoscopy protocols. Adjunctive endoscopic therapies, including argon plasma coagulation (APC), fistula tract abrasion or curettage, clips, over-the-scope clips (OTSC), endoscopic suturing, or stent placement, may be performed at the discretion of the treating physician. Repeat tSVF-EM treatment sessions may be undertaken based on clinical response and persistence of the fistula.
Composite Fistula Healing at 6 Months
Composite fistula healing is defined as the simultaneous achievement of: Clinical resolution of the fistula, characterized by the absence of fistula output, drainage, or symptoms attributable to the fistula; and Objective confirmation of closure demonstrated by either: Endoscopic evidence of complete closure of the fistula opening, or Radiological evidence of absence of contrast extravasation or fistulous communication on appropriate imaging studies. Participants meeting both criteria will be classified as having achieved successful fistula healing.
Time frame: 6 months following the first tSVF-EM treatment session
Number of tSVF-EM Treatment Sessions Required for Healing
Total number of endoscopic tSVF-EM treatment sessions required to achieve composite fistula healing.
Time frame: Up to 12 months after first treatment session
Time to Fistula Healing
Time from the first tSVF-EM treatment session to achievement of composite fistula healing, defined as clinical resolution of fistula output and objective confirmation of closure by endoscopy or imaging.
Time frame: Up to 12 months after first treatment session
Fistula Recurrence Rate
Proportion of participants who develop recurrence of a previously healed fistula, defined as reappearance of clinical drainage and/or objective evidence of fistula reopening after documented healing.
Time frame: 12 months after first treatment session
Treatment-Related Adverse Events
Incidence, type, severity, and outcome of adverse events related to adipose tissue harvest, endoscopic intervention, sedation/anesthesia, and delayed infectious complications. Adverse events will be graded according to the ASGE Lexicon classification system.
Time frame: From treatment initiation through 12 months of follow-up
Overall Clinical Healing Rate
Proportion of treated fistulas achieving clinical healing during the study period.
Time frame: 12 months after first treatment session
Need for Additional Endoscopic or Surgical Intervention
Proportion of participants requiring alternative endoscopic therapies, radiologic interventions, or surgery because of persistent or recurrent fistula despite tSVF-EM therapy.
Time frame: 12 months after first treatment session
Plan to share: No — ndividual participant-level data collected during this study will not be made publicly available. De-identified aggregate study results may be published in scientific journals and presented at scientific meetings.
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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Asian Institute of Gastroenterology, India →