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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Rajendra Patel, MBBS, DNB, DrNB
- Número de teléfono: +918152049069
- Correo electrónico: doc.rajendrapatel@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Goutham R Katukuri, MBBS, MD, DM
- Número de teléfono: +919902305703
- Correo electrónico: goutham.mge@gmail.com
Ubicaciones de estudio
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Telangana
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Hyderabad, Telangana, India, 500032
- Reclutamiento
- AIG Hospitals
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Contacto:
- Rajendra Patel, MBBS, DNB, DrNB
- Número de teléfono: +918152049069
- Correo electrónico: doc.rajendrapatel@gmail.com
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Investigador principal:
- Rajendra Patel, MBBS, DNB, DrNB
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Sub-Investigador:
- Goutham R Katukuri, MBBS, MD, DM
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Feasibility and Preliminary Efficacy at Week 24
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Cessation of fistula drainage
Periodo de tiempo: Week 24 & 52
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Week 24 & 52
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Rajendra Patel, MBBS, DNB, DrNB, AIG Hospitals
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- tSVF 1
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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