Condition: Crohn Disease (CD) · Perianal Crohns Disease · Sponsor: Asian Institute of Gastroenterology, India
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,…
This description comes directly from the study's public registry record.
Rajendra Patel, MBBS, DNB, DrNB · +918152049069 · doc.rajendrapatel@gmail.com
Goutham R Katukuri, MBBS, MD, DM · +919902305703 · goutham.mge@gmail.com
Always discuss trial participation with your own doctor first.
| AIG Hospitals | Hyderabad, Telangana, India | Recruiting |
| AIG Hospitals | Hyderabad, Telangana, India | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07652632