Treatment of Complex Crohns' Perianal Fistulas by Local Injection of Autologous and Micro-fragmented Adipose Tissue
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Healing
Study Overview
Brief Summary
The study aims to evaluate safety, feasibility and effectiveness of local injections of autologous and micro-fragmented adipose tissue obtained with the Lipogems® system in patients with refractory complex fistulizing perianal Crohn's disease.
Detailed Description
Complex perianal fistulas represent one of the most challenging manifestations of Crohn's disease. Combined surgical and medical therapy with biologic drugs today represents the first-line treatment option but the overall success rate does not exceed 60%. The treatment of patients in which complete closure cannot be achieved despite the combination of biological therapy and surgery, is still not well defined. These patients may benefit from innovative therapeutic approaches such as mesenchymal stromal cells. The adipose tissue is an ideal source, due to its abundance and easy access. The investigators evaluate safety, feasibility and effectiveness of local injections of micro-fragmented adipose tissue in patients with refractory complex fistulizing perianal Crohn's disease.
STUDY DESIGN This is a no profit interventional prospective study without drugs. A cohort of patients (15) with complex perianal Crohn's Disease, refractory to standard treatment with biologic drugs, or with secondary failure after initial effectiveness or presenting clinical contraindications to biological treatment are enrolled in the study.
After the enrolment, medical history and clinical data are collected and pre-operatory exams, pelvic MRI, and laboratory tests (erythrocyte sedimentation rate and C-reactive protein) are performed. Health-related quality of life is assessed by a disease-specific (Inflammatory Bowel Disease Questionnaire) and a generic (Short-Form 36 Health Survey) questionnaire.
METHODS
- Harvesting of the adipose tissue
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Signature of the informed consent
- •Diagnosis of Crohn's Disease confirmed by instrumental and histological methods
- •Age >18 years; both genders
- •Presence of complex fistulizing perianal Crohn's Disease refractory to standard treatment (combination of surgical drainage of sepsis and local/systemic administration of anti-tumor necrosis factor-alpha agents with subsequent surgical "rescue" repair by means of endoanal mucosal flap or biological plug placement).
Exclusion Criteria
- •Patients unable to follow the schedule of the protocol
- •Patients with ano- and recto-vaginal fistulas
- •Patients with active infections by Human Immunodeficiency Virus, hepatitis C virus, hepatitis B virus, tuberculosis, septic uncontrolled conditions
- •Patients with abdominal acute localization of Crohn's Disease that could have required general surgery during the study
- •Patients with oncological or lymphoproliferative active diseases
- •Patients where an adequate amount of lipoaspirate (at least 60 cc) could not be safely harvested
Arms & Interventions
Lipogems
Lipogems injection into the submucosa surrounding the internal fistula orifice and in the perianal tissue along the residual fistula tract
Intervention: Lipogems (Procedure)
Outcomes
Primary Outcomes
Healing
Time Frame: 6 months
Closing of the fistula tract clinically assessed and confirmed by pelvic MRI
Secondary Outcomes
- Health-related quality of life assessed by a disease specific questionnaire(6 months)
- Health-related quality of life assessed by a generic questionnaire(6 months)
Investigators
Silvio Laureti
Associated Professor
IRCCS Azienda Ospedaliero-Universitaria di Bologna