Идёт набор NCT07652632

Regenerative Endoscopy in Refractory Perianal Crohn's Disease

Без фазы С лечением Crohn Disease (CD) Perianal Crohns Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Autologous Mechanical Tissue Stromal Vascular Fraction (tSVF) Injection.
Кому может быть актуально: Состояния в реестре: Crohn Disease (CD), Perianal Crohns Disease. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Индия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Autologous Mechanical tSVF Injection in Refractory Perianal Fistulizing Crohn's Disease: A Single Arm Pilot Feasibility Study

Обзор

Perianal fistulizing Crohn's disease (pCD) represents a severe phenotype of Crohn's disease, affecting approximately 20-30% of patients and resulting in chronic drainage, recurrent sepsis, impaired continence, and reduced quality of life. Despite optimization of biologics, antibiotics, and surgical drainage, durable healing remains difficult to achieve. Conventional surgical approaches such as curettage or seton management alone yield modest remission rates, and repeated procedures may compromise sphincter integrity. Autologous mechanically processed tissue stromal vascular fraction (tSVF) is derived from adipose tissue using non enzymatic methods and can be prepared and reinjected during the same operative session. Unlike culture-expanded or enzymatically isolated cell products, mechanical tSVF retains a native adipose micro architecture containing stromal cells, perivascular elements, endothelial progenitors, extracellular matrix components, and bioactive cytokines. This heterogeneous microenvironment is hypothesized to exert immunomodulatory, pro angiogenic, and regenerative effects that may enhance tract healing while preserving sphincter function. Mechanical processing avoids enzymatic digestion, cell expansion, and complex laboratory infrastructure, making it potentially more feasible and cost effective in real world settings. However, high quality prospective data evaluating mechanically processed autologous tSVF specifically in refractory complex pCD remain limited, and feasibility data are required before undertaking a large randomized trial. This single arm pilot feasibility study is therefore designed to evaluate procedural feasibility, safety, and preliminary signals of clinical and radiological healing following mechanical tSVF injection in refractory complex perianal Crohn's disease. The results will inform design parameters, outcome variability, and sample size estimation for a future definitive multicenter trial.

Подробное описание

All participants receive a single session of autologous mechanical tSVF injection following the standardized standard operating procedure.

1. Removal of existing setons where applicable (documented in CRF 3) 2. Tumescent liposuction: harvest of 60-120 mL adipose tissue from lower abdomen or flank under tumescent anaesthesia (Klein formula) 3. Mechanical emulsification and filtration to obtain tSVF using the specified device and Standard operating procedure - minimum acceptable yield ≥5 mL 4. Intraoperative tSVF product quality check: Gram stain from final product; viability assessment by Trypan Blue exclusion where feasible; flow cytometry sample aliquot (sub-study, see Appendix D) 5. Fistula preparation: examination under anaesthesia (EUA), curettage of tract, and identification/closure of internal opening 6. tSVF injection (6-12 mL total): circumferentially around internal opening region in 0.1-0.3 mL blebs; along tract length avoiding sphincter penetration 7. Standard postoperative wound care and antibiotics per unit protocol

Вмешательства

Процедура Autologous Mechanical Tissue Stromal Vascular Fraction (tSVF) Injection
Autologous adipose tissue harvest by tumescent liposuction followed by same-session mechanical processing to obtain tissue stromal vascular fraction (tSVF) and local injection into the perianal fistula tract and internal opening region

Первичные конечные точки

Feasibility and Preliminary Efficacy at Week 24 [Срок оценки: Week 24]

Вторичные конечные точки (1)

Cessation of fistula drainage [Срок оценки: Week 24 & 52]

Критерии участия

Критерии включения

Age 18-65 years
Crohn's disease with complex perianal fistula (≥1 secondary tract or internal opening involvement)
Refractory to ≥1 biologic and/or ≥1 prior sphincter sparing procedure
No abscess on screening MRI
Mild or no proctitis on endoscopic assessment
CDAI <220
Stable IBD therapy ≥8 weeks
Able to provide informed consent