Micro-fragmented Adipose Tissue and Complex Crohns' Anal Fistulas

NCT03555773 | Completed

• 1 other identifier: Lipogems-crohn2
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease; Perianal Fistula

Keywords

perianal Crohn's disease; mesenchymal stromal cells; complex anal fistulas; micro-fragmented adipose tissue; regenerative medicine

Outcome Measures

Primary Outcomes (1)

• Healing

  Closing of the fistula tract clinically assessed and confirmed by pelvic MRI

  6 months

Secondary Outcomes (2)

• 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

Study Arms (1)

Lipogems

EXPERIMENTAL

Lipogems injection into the submucosa surrounding the internal fistula orifice and in the perianal tissue along the residual fistula tract

Procedure: Lipogems

Interventions

Lipogems PROCEDURE

After local surgical drainage of the perianal disease, micro-fragmented adipose tissue is injected circumferentially into the submucosa surrounding the internal fistula orifice and in the perianal tissue along the residual fistula tract.

Lipogems

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

S. Orsola-Malpighi Hospital

Bologna, BO, 40138, Italy

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Gilberto Poggioli, Prof

  S. Orsola-Malpighi Hospital, Department of Medical and Surgical Sciences (DIMEC), University of Bologna, Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Model Details: 15 patients with complex fistulizing perianal Crohn's disease refractory to biological therapy

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 14, 2018
• Study Start: May 11, 2016
• Primary Completion: June 28, 2017
• Study Completion: June 28, 2017
• Last Updated: June 14, 2018

Record last verified: 2018-06

Locations

IT (1)