Fat-Tissue Cell Injection for Hard-to-Treat Perianal Fistulas in Crohn's Disease
Tests an injection made from a person's own fat tissue in perianal Crohn's disease.
Plain-language title generated from the registry record
Registry title: Regenerative Endoscopy in Refractory Perianal Crohn's Disease
Key facts
- Where
- Hyderabad, IndiaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07652632, who can take part
Where in India
- AIG HospitalsHyderabad, IndiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Asian Institute of Gastroenterology, India
- Trial code
- NCT07652632
- Record updated
- 17 June 2026
- Original description
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.Read full original descriptionShow less
Autologous Mechanical tSVF Injection in Refractory Perianal Fistulizing Crohn's Disease: A Single Arm Pilot Feasibility Study
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.
Inclusion: 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: Rectovaginal fistula; Malignancy in tract or pelvic region; ASA IV status or bleeding disorder; Severe active proctitis requiring urgent escalation; Pregnancy or lactation; MRI contraindications.