NCT07652632 Regenerative Endoscopy in Refractory Perianal Crohn's Disease
| NCT ID | NCT07652632 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Asian Institute of Gastroenterology, India |
| Condition | Crohn Disease (CD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-04-20 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2026-04-20 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 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
Contact & Investigator
Rajendra Patel, MBBS, DNB, DrNB
PRINCIPAL INVESTIGATOR
AIG Hospitals
Frequently Asked Questions
Who can join the NCT07652632 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Crohn Disease (CD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07652632 currently recruiting?
Yes, NCT07652632 is actively recruiting participants. Contact the research team at doc.rajendrapatel@gmail.com for enrollment information.
Where is the NCT07652632 trial being conducted?
This trial is being conducted at Hyderabad, India, Hyderabad, India.
Who is sponsoring the NCT07652632 clinical trial?
NCT07652632 is sponsored by Asian Institute of Gastroenterology, India. The principal investigator is Rajendra Patel, MBBS, DNB, DrNB at AIG Hospitals. The trial plans to enroll 50 participants.