Back to resultsTreatment of Crohn's Complex Perianal Fistulas With Tissue Transplantation by Local Injection of Micro-fragmented Autologous Adipose Tissue. (ATTIC)
Primary Purpose
Crohn Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lipogems
Sponsored by
About this trial
This is an interventional treatment trial for Crohn Disease
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Lipogems
Placebo
Arm Description
surgical drainage with cone fistulectomy + infiltration of micro-fractured autologous adipose tissue at the level of the internal orifice
surgical drainage with cone fistulectomy + infiltration of physiological solution and suture point positioning at the internal orifice level
Outcomes
Primary Outcome Measures
Number of participants with Combined remission
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
Number of participants with Clinical remission
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.
Full Information
NCT ID
NCT05594862
First Posted
October 13, 2022
Last Updated
October 21, 2022
Sponsor
Lipogems International spa
1. Study Identification
Unique Protocol Identification Number
NCT05594862
Brief Title
Treatment of Crohn's Complex Perianal Fistulas With Tissue Transplantation by Local Injection of Micro-fragmented Autologous Adipose Tissue.
Acronym
ATTIC
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2022 (Anticipated)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lipogems International spa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lipogems
Arm Type
Active Comparator
Arm Description
surgical drainage with cone fistulectomy + infiltration of micro-fractured autologous adipose tissue at the level of the internal orifice
Arm Title
Placebo
Arm Type
No Intervention
Arm Description
surgical drainage with cone fistulectomy + infiltration of physiological solution and suture point positioning at the internal orifice level
Intervention Type
Device
Intervention Name(s)
Lipogems
Intervention Description
Micro-fragmented adipose tissue infiltration
Primary Outcome Measure Information:
Title
Number of participants with Combined remission
Description
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
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Number of participants with Clinical remission
Description
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.
Time Frame
2-4-8-12-24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raffaella Vignati
Phone
+390237072408
Email
raffaella.vignati@lipogems.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment of Crohn's Complex Perianal Fistulas With Tissue Transplantation by Local Injection of Micro-fragmented Autologous Adipose Tissue.
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