Regenerative Endoscopy in Refractory Perianal Crohn's Disease

NCT07652632 | Recruiting

• 1 other identifier: tSVF 1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Crohn Disease (CD); Perianal Crohns Disease

Keywords

tSVF; REPAIR-CD

Outcome Measures

Primary Outcomes (1)

• Feasibility and Preliminary Efficacy at Week 24

  •Assess feasibility (recruitment rate, retention to Week 24, protocol adherence, and tSVF processing success rate) and generate preliminary efficacy estimates for mechanical tSVF injection in refractory complex pCD.

  Week 24

Secondary Outcomes (1)

• Cessation of fistula drainage

  Week 24 & 52

Study Arms (1)

Autologous tSVF Injection for Perianal Crohn's Disease

EXPERIMENTAL

Participants with refractory complex perianal fistulizing Crohn's disease will undergo adipose tissue harvesting by tumescent liposuction, mechanical processing to obtain tissue stromal vascular fraction (tSVF), and local injection of tSVF around the internal opening and along the fistula tract, with standard postoperative care and continuation of stable background IBD therapy.

Procedure: Autologous Mechanical Tissue Stromal Vascular Fraction (tSVF) Injection

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

Autologous tSVF Injection for Perianal Crohn's Disease

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (2)

AIG Hospitals

Hyderabad, Telangana, 500032, India

RECRUITING

AIG Hospitals

Hyderabad, Telangana, 500032, India

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Interventions

Injections

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Rajendra Patel, MBBS, DNB, DrNB

  AIG Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rajendra Patel, MBBS, DNB, DrNB

CONTACT

+918152049069; doc.rajendrapatel@gmail.com

Goutham R Katukuri, MBBS, MD, DM

CONTACT

+919902305703; goutham.mge@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Gastroenterologist

Model Details: Single-Arm Prospective Feasibility Study

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 17, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): March 1, 2028
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)