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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04750499
Other study ID # Fistula_CM1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date September 2024

Study information

Verified date February 2023
Source Hospital Clinic of Barcelona
Contact Salvador Guillaumes, MD PhD
Phone +34 687 795 458
Email guillaumes@clinic.cat
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 12
Est. completion date September 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Adipose tissue injection associated with endorectal advancement flap.
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.

Locations

Country Name City State
Spain Hospital Clínic Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Healing rate Fistula tract closing by clinically assessment and confirmation by pelvic MRI if necessary. 1 year
Secondary 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). 1 year
Secondary Treatment related adverse events Reported adverse events designated as related to treatment 1 year
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