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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05594862
Recruitment Status : Not yet recruiting
First Posted : October 26, 2022
Last Update Posted : October 26, 2022
Sponsor:
Information provided by (Responsible Party):
Lipogems International spa

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Crohn Disease Device: Lipogems Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Treatment of Crohn's Complex Perianal Fistulas With Tissue Transplantation by Local Injection of Micro-fragmented Autologous Adipose Tissue. Multicenter Randomized Controlled Prospective Study
Estimated Study Start Date : November 2022
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Active Comparator: Lipogems
surgical drainage with cone fistulectomy + infiltration of micro-fractured autologous adipose tissue at the level of the internal orifice
Device: Lipogems
Micro-fragmented adipose tissue infiltration

No Intervention: Placebo
surgical drainage with cone fistulectomy + infiltration of physiological solution and suture point positioning at the internal orifice level



Primary Outcome Measures :
  1. Number of participants with Combined remission [ Time Frame: 24 weeks ]
    The primary outcome of the study will be the evaluation of the difference between the two experimental groups in terms of "combined remission" which will be defined at 24 weeks from surgery to clinical evaluation as "absence of drainage at a slight digital compression". of all treated external orifices that were draining at baseline and pelvic MRI as the absence of abscesses> 3 mm in correspondence of the treated perianal fistulas


Secondary Outcome Measures :
  1. Number of participants with Clinical remission [ Time Frame: 2-4-8-12-24 weeks ]
    Comparison between the two experimental groups in terms of clinical remission at 2 weeks (± 2 days), 4 weeks (± 2 days), 8 weeks (± 2 days), 12 weeks (± 3 days) and 24 weeks ± (5 days) from surgery (ie the closure of all external orifices treated that were draining at baseline despite a slight digital compression) with the presence of abscess collections> 3 mm on MRI.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05594862


Contacts
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Contact: Raffaella Vignati +390237072408 raffaella.vignati@lipogems.com

Sponsors and Collaborators
Lipogems International spa
  Study Documents (Full-Text)

Documents provided by Lipogems International spa:
Study Protocol  [PDF] July 15, 2022

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Responsible Party: Lipogems International spa
ClinicalTrials.gov Identifier: NCT05594862    
Other Study ID Numbers: ATTIC
First Posted: October 26, 2022    Key Record Dates
Last Update Posted: October 26, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Fistula
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical