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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Rajendra Patel, MBBS, DNB, DrNB
- Número de telefone: +918152049069
- E-mail: doc.rajendrapatel@gmail.com
Estude backup de contato
- Nome: Goutham R Katukuri, MBBS, MD, DM
- Número de telefone: +919902305703
- E-mail: goutham.mge@gmail.com
Locais de estudo
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Telangana
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Hyderabad, Telangana, Índia, 500032
- Recrutamento
- AIG Hospitals
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Contato:
- Rajendra Patel, MBBS, DNB, DrNB
- Número de telefone: +918152049069
- E-mail: doc.rajendrapatel@gmail.com
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Investigador principal:
- Rajendra Patel, MBBS, DNB, DrNB
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Subinvestigador:
- Goutham R Katukuri, MBBS, MD, DM
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Feasibility and Preliminary Efficacy at Week 24
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Cessation of fistula drainage
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- tSVF 1
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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