Regenerative Endoscopy in Refractory Perianal Crohn's Disease
Not applicable · Testing Autologous Mechanical Tissue Stromal Vascular Fraction (tSVF) Injection · 2 sites · Asian Institute of Gastroenterology, India
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Autologous Mechanical Tissue Stromal Vascular Fraction (tSVF) Injection (a procedure) as a possible treatment. Condition(s) listed: Crohn Disease (CD) and Perianal Crohns Disease.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 65
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 5 more requirement(s). There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 50 participants are expected to take part.
- Start date: 2026-04-20.
- Main results expected around 2026-10 (estimate from the record).
- 2 study sites listed (2 marked recruiting) in India.
Main thing being measured
- Feasibility and Preliminary Efficacy at Week 24 (Week 24)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn Disease (CD); Perianal Crohns Disease |
| Lead sponsor | Asian Institute of Gastroenterology, India |
| Enrollment | 50 (estimated) |
| Start date | 2026-04-20 |
| Primary completion (est.) | 2026-10 |
| First posted | 2026-06-17 |
| Last updated | 2026-06-17 |
| Official title | Autologous Mechanical tSVF Injection in Refractory Perianal Fistulizing Crohn's Disease: A Single Arm Pilot Feasibility Study |
| ClinicalTrials.gov ID | NCT07652632 |
Interventions
- Autologous Mechanical Tissue Stromal Vascular Fraction (tSVF) Injection (Procedure)
Autologous adipose tissue harvest by tumescent liposuction followed by same-session mechanical processing to obtain tissue stromal vascular fraction (tSVF) and local injection into the perianal fistula tract and internal opening region
Full eligibility criteria (from the record)
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
Locations (2)
| Site | City | Country | Site status |
|---|---|---|---|
| AIG Hospitals | Hyderabad, Telangana | India | Recruiting |
| AIG Hospitals | Hyderabad, Telangana | India | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.