Study currently suspended due to device-related issues

Interventional, prospective, randomized, controlled, double blind, parallel groups, nonprofit, single center trial

The goal of this clinical trial is to compare, the efficacy of

• circumferential infiltration of microfractured autologous adipose tissue combined with the placement of a biological prosthesis in the fistula tract versus
• endoanal mucosal flap in terms of clinical and radiological healing (combined remission)

in patients with Crohn's rectovaginal fistulas refractory to standard treatment,

Secondary objectives are improvement of the clinical outcome (clinical remission, clinical response, failure), time elapsed between surgery and clinical outcome, onset of any recurrences, safety and improvement in quality of life.

Inclusion Criteria:

• Confirmed Crohn's disease
• presence of recto-vaginal fistula refractory to standard treatment (surgical drainage of sepsis and treatment with biological drg for at least 12 months)
• The patient has received, understood and signed the informed consent to actively participate in the study.
• The patient is able to understand the conditions of the study and to participate for the whole duration.

Exclusion Criteria:

• presence of oostomy
• Patients with active HIV, hepatitis C (HCV), hepatitis B (HBV), tuberculosis or other uncontrolled septic conditions.
• Patients who present technical difficulties, in the opinion of the investigator, in safely recovering the amount of adipose tissue necessary for the procedure.
• Patients with abdominal localization of Crohn's disease who may require general surgery during the study.
• Patients with active oncological or lymphoproliferative diseases
• Pregnant or breastfeeding women

Patients with recto-vaginal fistulas

Randomization procedures and statistical analyses will be performed by an investigator not involved in the clinical evaluation or surgical treatment of patients. All clinical evaluations will be performed by independent co-investigators not involved in the surgical procedures and blinded to patient assignment. The dedicated radiologist who will evaluate the MRI scans will be blind to patient allocation. Surgeons will not be able to share information about the treatment used in the surgical procedure and will not be able to participate in any clinical evaluation of the MPC during the study.