Treatment of Perianal Fistulas by Endorectal Advancement Flap Associated With Adipose Tissue Injection (Fistula_CM1)
Primary Purpose
Anal Fistula
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Adipose tissue injection associated with endorectal advancement flap.
Sponsored by
About this trial
This is an interventional treatment trial for Anal Fistula focused on measuring Complex Anal Fistula, Mesenchymal Stem Cells, Microfragmented adipose tissue, Regenerative Medicine
Eligibility Criteria
Inclusion Criteria:
- Patients of both genders, aged over 18 years old.
- Diagnosis, confirmed by standard methods (magnetic resonance and/or trans-anal ultrasound), of complex fistula (trans-sphincteric unsuitable for treatment lay-open).
- Seton placed at least 4-6 weeks previously.
- No limitations to a periodic follow-up lasting for a total of 12 months
- Informed consent form signed.
Exclusion Criteria:
- Active septic process.
- Patients unable to follow the pathway required by the protocol.
- Pregnant women.
- Failure to sign the informed consent form
Sites / Locations
- Hospital ClínicRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Patients with complex anal fistulas, non related to Crohn's disease.
Outcomes
Primary Outcome Measures
Healing rate
Fistula tract closing by clinically assessment and confirmation by pelvic MRI if necessary.
Secondary Outcome Measures
Incontinence rate
Presence of Fecal Incontinence Measured by the Wexner score instrument, The scoring of the instrument ranges from 0 (no incontinence) to 20 (complete incontinence).
Treatment related adverse events
Reported adverse events designated as related to treatment
Full Information
NCT ID
NCT04750499
First Posted
February 8, 2021
Last Updated
October 31, 2022
Sponsor
Hospital Clinic of Barcelona
1. Study Identification
Unique Protocol Identification Number
NCT04750499
Brief Title
Treatment of Perianal Fistulas by Endorectal Advancement Flap Associated With Adipose Tissue Injection
Acronym
Fistula_CM1
Official Title
Treatment of Complex Perianal Fistulas, in Patients Without Crohn's Disease, by Endorectal Advancement Flap Associated With Injection of Autologous and Micro-fragmented Adipose Tissue
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Clinic of Barcelona
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
The study aims to evaluate effectiveness of the association of endorectal advancement flap technique with local injection of autologous and micro-fragmented adipose tissue, obtained with the Lipogems® system, in patients with complex Perianal Fistulas not related to Crohn's Disease.
Detailed Description
Treatment of anal fistula pursues permanent healing and preservation of anal continence, not always easy goals in complex anal fistulas.
In patients with Crohn's disease, simple surgery (ligation of the path and suturing of the internal orifice) associated with injections of stem cells derived from autologous or allogeneic adipose tissue has been shown to cure up to 70%. of the cases. Similar results have been obtained in small series of patients with fistulas of cryptoglandular origin and also in rectourethral and rectovaginal fistulas of other etiologies. Unfortunately, this treatment is time consuming and extremely expensive.
Fresh adipose tissue is an alternative source of mesenchymal stem cells (MSC) with regenerative capabilities, immunomodulatory angiogenic and anti-inflammatory effects. The injection of fresh adipose tissue, obtained by liposuction from the same patient, is currently a therapeutic alternative used in regenerative medicine, plastic and orthopedic surgery indications, as well in other fields. Beneficial effects of fresh adipose tissue on anus fistulas and fecal incontinence have also been reported.
The aim of the present study is to evaluate the effectiveness of the injection of autologous, microfragmented and minimally manipulated adipose tissue, associated with a surgical technique that obtains by itself up to 70% cure in order to add the benefits of surgery with those in regenerative medicine hoping that the beneficial effects of MSC will aid in the healing and repair process.
A prospective study is proposed in 12 patients with non-Crohn's-related complex anals fistulas. Whenever possible, the endorectal advancement flap technique will be applied; in blind fistulas and special cases, in which the flap is not indicated, alternative techniques will be used. In all cases, autologous, micro-fragmented and minimally manipulated adipose tissue, obtained with a standardized procedure, previously validated and authorized, will be injected. This procedure uses the "Lipogems ®" device (Lipogems International SpA, Milan, Italy), with which a well-characterized adipose tissue is obtained with the maximum safety guarantees.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Fistula
Keywords
Complex Anal Fistula, Mesenchymal Stem Cells, Microfragmented adipose tissue, Regenerative Medicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Interventional (Clinical Trial)
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Patients with complex anal fistulas, non related to Crohn's disease.
Intervention Type
Procedure
Intervention Name(s)
Adipose tissue injection associated with endorectal advancement flap.
Intervention Description
Injection of adipose tissue will be associated with endorectal advancement flap technique. In blind fistulas and special cases, in which the flap is not indicated, alternative techniques will be used. In all cases, autologous, micro-fragmented and minimally manipulated adipose tissue, obtained with a standardized procedure, previously validated and authorized, will be injected. This procedure uses the "Lipogems ®" device (Lipogems International SpA, Milan, Italy), with which a well-characterized adipose tissue is obtained with the maximum safety guarantees.
Primary Outcome Measure Information:
Title
Healing rate
Description
Fistula tract closing by clinically assessment and confirmation by pelvic MRI if necessary.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Incontinence rate
Description
Presence of Fecal Incontinence Measured by the Wexner score instrument, The scoring of the instrument ranges from 0 (no incontinence) to 20 (complete incontinence).
Time Frame
1 year
Title
Treatment related adverse events
Description
Reported adverse events designated as related to treatment
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients of both genders, aged over 18 years old.
Diagnosis, confirmed by standard methods (magnetic resonance and/or trans-anal ultrasound), of complex fistula (trans-sphincteric unsuitable for treatment lay-open).
Seton placed at least 4-6 weeks previously.
No limitations to a periodic follow-up lasting for a total of 12 months
Informed consent form signed.
Exclusion Criteria:
Active septic process.
Patients unable to follow the pathway required by the protocol.
Pregnant women.
Failure to sign the informed consent form
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Salvador Guillaumes, MD PhD
Phone
+34 687 795 458
Email
guillaumes@clinic.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salvador Guillaumes, MD PhD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nils Jimmy Hidalgo, MD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Irene Bachero, MD
Organizational Affiliation
Hospital Clinbic. Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínic
City
Barcelona
ZIP/Postal Code
08006
Country
Spain
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29453515
Citation
Naldini G, Sturiale A, Fabiani B, Giani I, Menconi C. Micro-fragmented adipose tissue injection for the treatment of complex anal fistula: a pilot study accessing safety and feasibility. Tech Coloproctol. 2018 Feb;22(2):107-113. doi: 10.1007/s10151-018-1755-8. Epub 2018 Feb 16.
Results Reference
background
PubMed Identifier
29277560
Citation
Panes J, Garcia-Olmo D, Van Assche G, Colombel JF, Reinisch W, Baumgart DC, Dignass A, Nachury M, Ferrante M, Kazemi-Shirazi L, Grimaud JC, de la Portilla F, Goldin E, Richard MP, Diez MC, Tagarro I, Leselbaum A, Danese S; ADMIRE CD Study Group Collaborators. Long-term Efficacy and Safety of Stem Cell Therapy (Cx601) for Complex Perianal Fistulas in Patients With Crohn's Disease. Gastroenterology. 2018 Apr;154(5):1334-1342.e4. doi: 10.1053/j.gastro.2017.12.020. Epub 2017 Dec 24.
Results Reference
background
PubMed Identifier
22706128
Citation
Herreros MD, Garcia-Arranz M, Guadalajara H, De-La-Quintana P, Garcia-Olmo D; FATT Collaborative Group. Autologous expanded adipose-derived stem cells for the treatment of complex cryptoglandular perianal fistulas: a phase III randomized clinical trial (FATT 1: fistula Advanced Therapy Trial 1) and long-term evaluation. Dis Colon Rectum. 2012 Jul;55(7):762-72. doi: 10.1097/DCR.0b013e318255364a.
Results Reference
background
PubMed Identifier
23051701
Citation
Bianchi F, Maioli M, Leonardi E, Olivi E, Pasquinelli G, Valente S, Mendez AJ, Ricordi C, Raffaini M, Tremolada C, Ventura C. A new nonenzymatic method and device to obtain a fat tissue derivative highly enriched in pericyte-like elements by mild mechanical forces from human lipoaspirates. Cell Transplant. 2013;22(11):2063-77. doi: 10.3727/096368912X657855. Epub 2012 Oct 8.
Results Reference
background
PubMed Identifier
27236668
Citation
Tremolada C, Ricordi C, Caplan AI, Ventura C. Mesenchymal Stem Cells in Lipogems, a Reverse Story: from Clinical Practice to Basic Science. Methods Mol Biol. 2016;1416:109-22. doi: 10.1007/978-1-4939-3584-0_6.
Results Reference
background
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Treatment of Perianal Fistulas by Endorectal Advancement Flap Associated With Adipose Tissue Injection
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