Autologous tSVF Injection for Refractory Perianal Crohn’s Disease
Official title: Autologous Mechanical tSVF Injection in Refractory Perianal Fistulizing Crohn's Disease: A Single Arm Pilot Feasibility Study
Run by Asian Institute of Gastroenterology, India · NCT07652632 · Data updated 2026-11-12
We’re testing whether injecting a patient’s own mechanically processed tissue stromal vascular fraction around and into fistula tracts can help heal complex perianal Crohn’s disease in people who have not responded to standard therapies.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Asian Institute of Gastroenterology, India Academic / other |
| Locations | 2 sites (Hyderabad, Telangana and 1 other locations) |
| Status | Recruiting |
| Started | April 20, 2026 |
| Main results expected | October 2026 |
| Study ends | March 2028 |
| Registry record updated | June 17, 2026 |
| Trial ID | NCT07652632 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18-65 with complex perianal Crohn’s disease refractory to at least one biologic and/or prior sphincter-sparing procedure, without abscess on MRI and with mild/no proctitis.
✕Probably not a fit
Patients with active abscess, rectovaginal fistula, severe proctitis, pelvic malignancy, pregnancy, significant bleeding disorders, or MRI contraindications may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study uses autologous mechanical tSVF, derived from the patient’s fat tissue, injected during a single operation after fistula preparation. The procedure includes liposuction to collect adipose tissue, mechanical processing to obtain tSVF, a viability/quality check, and targeted injection around the fistula’s internal opening and along the tract. All participants receive the same intraoperative tSVF treatment with standard postoperative care. Eligibility targets adults with refractory complex perianal Crohn’s disease who have not achieved durable healing with prior biologics or sphincter-sparing procedures.
Why it matters
Potential benefit: If successful, patients may experience improved fistula healing and quality of life through a minimally invasive, autologous regenerative approach.
How similar studies have gone: Prior studies in regenerative approaches for perianal Crohn’s disease show variable but promising fistula healing with autologous cell-based therapies; this approach applies a mechanical, non-enzymatic tSVF technique.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
AIG Hospitals
Hyderabad, Telangana, India Recruiting -
AIG Hospitals
Hyderabad, Telangana, India Recruiting
Study contacts
- Principal investigator: Rajendra Patel, MBBS, DNB, DrNB — AIG Hospitals
- Study coordinator: Rajendra Patel, MBBS, DNB, DrNB
- Email: doc.rajendrapatel@gmail.com
- Phone: +918152049069
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.