Treatment of Crohn's Complex Perianal Fistulas With Tissue Transplantation by Local Injection of Micro-fragmented Autologous Adipose Tissue.

Study Purpose

multicentre randomized controlled prospective study aimed at evaluating the efficacy of the infiltration of microfractured adipose tissue in the healing of perianal fistulas not-responding to treatment with biologics, in order to improve the quality of life and significantly reduce the risk of definitive ostomy.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- The patient's age is over 18 at the time of surgery.

- The patient suffers from Crohn's disease confirmed by instrumental and histological methods.

- The patient presents with complex perianal fistulising disease refractory to standard treatment (combination of surgical drainage of sepsis and local / systemic administration of anti-TNF-α for at least 1 year) - The patient received, understood and signed informed consent for active participation in the study.

- The patient is able to understand the conditions of the study and to participate throughout the duration.

Exclusion Criteria:

- Patients with more than 1 internal and 3 external openings.

- Patients with ileus / colo ostomy.

- Patients with anus / rectum-vaginal fistulas.

- Patients with active HIV infections, hepatitis C (HCV), hepatitis B (HBV), tuberculosis.

- Patients with abdominal localization of Crohn's disease who may require general surgery during the study.

- Patients with active oncological or lymphoproliferative diseases from which it was not possible to safely withdraw an adequate quantity of lipoaspirate (at least 60 cc).

- Patients with clinical conditions that may compromise the success of the surgery or the follow-up.

- Pregnant or breastfeeding women.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05594862
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Lipogems International spa
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Crohn Disease

Arms & Interventions

Arms

Active Comparator: Lipogems

surgical drainage with cone fistulectomy + infiltration of micro-fractured autologous adipose tissue at the level of the internal orifice

No Intervention: Placebo

surgical drainage with cone fistulectomy + infiltration of physiological solution and suture point positioning at the internal orifice level

Interventions

Device: - Lipogems

Micro-fragmented adipose tissue infiltration

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Raffaella Vignati

raffaella.vignati@lipogems.com

+390237072408

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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