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โ† Trials
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Regenerative Endoscopy in Refractory Perianal Crohn's Disease

RecruitingNAAges 18 Years - 65 YearsAllAsian Institute of Gastroenterology, India
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In plain words

What the trial is, and whether it could suit you

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,

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age 18-65 years * Crohn's disease with complex perianal fistula (โ‰ฅ1 secondary tract or internal opening involvement) * Refractory to โ‰ฅ1 biologic and/or โ‰ฅ1 prior sphincter sparing procedure * No abscess on screening MRI * Mild or no proctitis on endoscopic assessment * CDAI \<220 * Stable IBD therapy โ‰ฅ8 weeks * Able to provide informed consent Exclusion Criteria: * Rectovaginal fistula * Severe active proctitis requiring urgent escalation * Malignancy in tract or pelvic region * Pregnancy or lactation * ASA IV status or bleeding disorder * MRI contraindications
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What it tests

  • Autologous Mechanical Tissue Stromal Vascular Fraction (tSVF) Injection
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Where

2 sites
AIG Hospitals
Hyderabad, India
AIG Hospitals
Hyderabad, India
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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