Regenerative Endoscopy in Refractory Perianal Crohn's Disease (REPAIR-pCD)
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
All participants receive a single session of autologous mechanical tSVF injection following the standardized standard operating procedure.
- Removal of existing setons where applicable (documented in CRF 3)
- Tumescent liposuction: harvest of 60-120 mL adipose tissue from lower abdomen or flank under tumescent anaesthesia (Klein formula)
- Mechanical emulsification and filtration to obtain tSVF using the specified device and Standard operating procedure - minimum acceptable yield ≥5 mL
- Intraoperative tSVF product quality check: Gram stain from final product; viability assessment by Trypan Blue exclusion where feasible; flow cytometry sample aliquot (sub-study, see Appendix D)
- Fistula preparation: examination under anaesthesia (EUA), curettage of tract, and identification/closure of internal opening
- tSVF injection (6-12 mL total): circumferentially around internal opening region in 0.1-0.3 mL blebs; along tract length avoiding sphincter penetration
- Standard postoperative wound care and antibiotics per unit protocol
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Rajendra Patel, MBBS, DNB, DrNB
- Telefoonnummer: +918152049069
- E-mail: doc.rajendrapatel@gmail.com
Studie Contact Back-up
- Naam: Goutham R Katukuri, MBBS, MD, DM
- Telefoonnummer: +919902305703
- E-mail: goutham.mge@gmail.com
Studie Locaties
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Telangana
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Hyderabad, Telangana, Indië, 500032
- Werving
- AIG Hospitals
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Contact:
- Rajendra Patel, MBBS, DNB, DrNB
- Telefoonnummer: +918152049069
- E-mail: doc.rajendrapatel@gmail.com
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Hoofdonderzoeker:
- Rajendra Patel, MBBS, DNB, DrNB
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Onderonderzoeker:
- Goutham R Katukuri, MBBS, MD, DM
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Autologous tSVF Injection for Perianal Crohn's Disease
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.
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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
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Feasibility and Preliminary Efficacy at Week 24
Tijdsspanne: Week 24
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•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.
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Week 24
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Cessation of fistula drainage
Tijdsspanne: Week 24 & 52
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Week 24 & 52
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Rajendra Patel, MBBS, DNB, DrNB, AIG Hospitals
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- tSVF 1
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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